Lung Cancer

EA5191



Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer

STATUS: Active


This phase II trial compares cabozantinib alone and the combination of cabozantinib and nivolumab to standard chemotherapy in the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as docetaxel, gemcitabine hydrochloride, paclitaxel, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cabozantinib alone or in combination with nivolumab may be more effective than standard chemotherapy in treating patients with non-small cell lung cancer.
  • ELIGIBILITY CRITERIA FOR STEP 0 (PRE-REGISTRATION): Patient must have pathologically confirmed non-squamous non-small cell lung carcinoma (NSCLC)

  • ELIGIBILITY CRITERIA FOR STEP 0 (PRE-REGISTRATION): Patient must have stage IV disease (includes M1a, M1b, or recurrent earlier stage disease), according to the 8th edition of the lung cancer Tumor Node Metastasis (TNM) classification system

  • ELIGIBILITY CRITERIA FOR STEP 0 (PRE-REGISTRATION): Patient must have predominant non-squamous histology (patients with NSCLC no otherwise specified [NOS] are eligible). Mixed tumors will be categorized by the predominant cell type. If small cell elements are present the patient is ineligible

  • ELIGIBILITY CRITERIA FOR STEP 0 (PRE-REGISTRATION): Patientโ€™s tumor(s) must be tested and known negative for EGFR tyrosinase kinase inhibitor (TKI) sensitizing mutations (EGFR Exon 19 deletions, L858R, L861Q, G719X) and ALK gene rearrangements (by fluorescence in situ hybridization [FISH], next generation sequencing [NGS], or immunohistochemistry [IHC]) by routine Clinical Laboratory Improvement Act (CLIA)-certified clinical testing methods. Negative circulating tumor deoxyribonucleic acid (DNA) results alone are not acceptable. Prior testing for tumor PD-L1 status is not required

  • ELIGIBILITY CRITERIA FOR STEP 0 (PRE-REGISTRATION): Patients WITHOUT tumors with known molecular alterations in ROS1, MET, RET, or must have progressed radiographically (per local investigator assessment) following one, but only one, line of platinum-based chemotherapy AND one, but only one, line of prior immunotherapy. Lines of therapy are defined by clinical or radiographic progression. Patients may have received chemotherapy and immunotherapy either concurrently or sequentially in either order. Patient must have received at least 2 prior doses of checkpoint inhibitor therapy in an every 2, 3, or 4 week schedule. No submission of molecular testing is required and patients may be registered for Step 0 then proceed directly to Step 1 screening OR Patients with tumors with known molecular alterations in ROS1, MET, and RET must have progressed radiographically (per local investigator clinical assessment) on at least one line of prior chemotherapy or targeted therapy, but there is no limit on number of prior number. Reciept of prior immunotherapy is allowed but not required. * Known molecular alterations in ROS1 , MET, and RET are defined as below ROS1 gene rearrangement by FISH or DNA analysis. In addition to above requirements, these patients must have progressed on at least one prior ROS1 TKI therapy * MET exon 14 splice mutations on DNA analysis. In addition to above requirements, prior MET directed TKI therapy is optional * MET mutations predicted to be sensitive to MET inhibitor. In addition to above requirements, prior MET directed TKI therapy is optional * High MET amplification by FISH (characterized by a fluorescence in situ hybridization MET/CEP7 ratio of 5 or greater); OR MET amplification by DNA NGS CLIA certified assay. In addition to above requirements, prior MET directed TKI therapy is optional * RET gene rearrangement by FISH or DNA analysis. In addition to above requirements, prior RET directed TKI therapy is optional ** During Step 0 screening, CLIA reports of the testing results must be submitted via Medidata Rave for central review for instructions. The central review will be performed by the study chair, co-chair, biology co-chair, and/or a delegate to determine that the results indicate a patientโ€™s eligibility for targeted therapy. CLIA reports that contain information pertaining to any of the above mutations will be uploaded to Medidata Rave for central review of documentation for determination of patient eligibility for targeted therapy (Arm T). Central testing of tissue will not be performed. Institutions will be notified of the patientโ€™s eligibility status for Arm T within two (2) business days of submission of the molecular testing reports. Patients with tumors with the above known molecular alterations are eligible for cohort Arm Z following Step 1 eligibility review. Patients without tumors with the above known molecular alterations for randomization to Arm A, B or C following Step 1 eligibility review

  • ELIGIBILITY CRITERIA FOR STEP 0 (PRE-REGISTRATION): NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (in the opinion of the treating physician) are eligible for this trial

  • ELIGIBILITY CRITERIA FOR STEP 0 (PRE-REGISTRATION): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents (such as anthracycline or human epidermal growth factor receptor (HER2)-directed antibody therapy, but not prior checkpoint inhibitor therapy), must have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients must be class 2B or better

  • ELIGIBILITY CRITERIA FOR STEP 0 (PRE-REGISTRATION): Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patient must have met the eligibility criteria outlined above

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patient must have measurable disease as defined by RECIST version (v) 1.1 criteria. Measurements must be obtained within 4 weeks prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patient must have an anticipated life expectancy greater than 3 months

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the following times prior to randomization/registration: * Chemotherapy/targeted oral therapy administered in a daily or weekly schedule must be completed >= 1 week prior to randomization/registration * Any chemotherapy administered in an every 2 week or greater schedule must be completed >= 2 weeks prior to randomization/registration * Additionally, patient should be recovered to equal to or less than grade 1 toxicities related to any prior treatment, unless adverse events (AE[s]) are clinically non significant and/or stable on supportive therapy (as determined by the treating physician)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patient must not have had any prior radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Leukocytes >= 3,000/mcL (obtained within 2 weeks prior to randomization/registration)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Absolute neutrophil count >= 1,500/mcL (obtained within 2 weeks prior to randomization/registration)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Platelets >= 100,000/mcL (obtained within 2 weeks prior to randomization/registration)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Hemoglobin >= 9 g/dL (obtained within 2 weeks prior to randomization/registration)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained within 2 weeks prior to randomization/registration)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN (obtained within 2 weeks prior to randomization/registration)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Creatinine =< 1.5 x ULN OR calculated (Cockcroft-Gault formula) or measured creatinine clearance >= 50 mL/min/1.73 m^2 (normalized to body surface area [BSA]) for patients with creatinine levels greater than 1.5 times the institutional normal creatinine =< 1.5 x ULN or creatinine clearance >= 50 ml/min/1.73 m^2 (obtained within 2 weeks prior to randomization/registration)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Women must not be pregnant or breast-feeding due to the unknown effects of cabozantinib and nivolumab on human development and for the potential risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization/registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has achieved menarche at some point, * Has not undergone a hysterectomy or bilateral oophorectomy; * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for up to 7 months after completion of treatment on the study

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Clinically significant gastrointestinal bleeding within 6 months prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Pulmonary hemorrhage or hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Any grade drug induced pneumonitis within 3 months prior to randomization/registration. Prior immune mediated pneumonitis of grade 3 or 4 are not eligible regardless of time window

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Current radiographic evidence of cavitating pulmonary lesion(s)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Current radiographic evidence of tumor invading any major blood vessels

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or mainstem endobronchial tumor within 28 days prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Peptic ulcer disease, inflammatory bowel, known malabsorption syndrome, bowel obstruction or gastric outlet obstruction (percutaneous endoscopic gastrostomy [PEG] tube placement) within 3 months prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Abdominal fistula, GI perforation, intra-abdominal abscess within 6 months prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Grade 3 or greater infection, or infection requiring intravenous systemic treatment within 28 days prior to randomization/registration. Patients should be off antibiotics at the time of randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Serious non-healing wound/ulcer/bone fracture within 28 days prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: History of organ transplant

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Concurrent symptomatic untreated hypothyroidism within 7 days prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: History of major surgery (within 3 months, with wound healing within 28 days, prior to randomization/registration), minor surgery (within 28 days prior to randomization/registration), other minor procedures (within 7 days prior to randomization/registration) or clinically relevant ongoing complications from prior surgery

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic, or > 90 mm Hg diastolic within 7 days of registration despite optimal antihypertensive treatment

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Unstable angina pectoris (within 6 months prior to therapy)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Clinically-significant cardiac arrhythmias (within 6 months prior to therapy)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Stroke (including transient ischemic attack [TIA], or other ischemic event) (within 6 months prior to therapy)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Myocardial infarction (within 6 months prior to therapy)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose (within 6 months prior to therapy) * NOTE: Subjects with a diagnosis of deep vein thrombosis (DVT) (but not pulmonary embolism [PE]) within 6 months are allowed if stable, asymptomatic, and treated with low molecular weight heparin (LMWH) for at least 2 weeks before first dose

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patient must not receive concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) within 7 days prior to randomization/registration. Allowed anticoagulants are the following: * Low-dose aspirin (100 mg PO daily or less) is permitted * Anticoagulation with therapeutic doses of LMWH is allowed in patients who are on a stable dose of LMWH for at least 6 weeks prior to study randomization/registration, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor within this time period

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patient must not receive concomitant treatment of strong CYP3A4 inducers (e.g., dexamethasone (> 1 mg daily dosing), phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. Johnโ€™s Wort) within 7 days prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patient must have corrected QT interval calculated by the Fridericia formula QTc corrected by Fridericia (QTcF) =< 500 ms within 28 days prior to randomization/registration

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patient must be able to swallow tablets

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patient must not be on systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to randomization/registration, with the following exceptions: * Inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease * Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption) * Physiologic replacement doses of systemic corticosteroids are permitted, if < 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patients with new or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of study treatment. * Patient must meet one of the following criteria with respect to brain metastases: Patients with no known brain metastasis must have baseline brain imaging within 12 weeks prior to study randomization/registration not demonstrating brain metastases OR patients with known brain metastases must have baseline brain imaging and completed treatment to all symptomatic brain metastases (with whole brain radiation or radiosurgery; or complete neurosurgical resection >= 3 months prior to randomization/registration) >= 4 weeks prior to randomization/registration. They must be clinically stable. Known leptomeningeal disease is not allowed

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patient must not have known active autoimmune disease or known history of autoimmune disease for which recurrence may affect vital organ function or require immune suppressive treatment including systemic corticosteroids (e.g., immune-related neurologic disease, multiple sclerosis, autoimmune neuropathy, Guillain-Barre syndrome, etc.)

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: For patients with known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy at time of registration/randomization, if indicated

  • ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION/REGISTRATION) FOR ALL TREATMENT ARMS: Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load at time of registration/randomization

  • ADDITIONAL ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION) ARMS A-C: Patient must not be eligible for the targeted therapy arm (Arm T) per one of the following criteria: * Patient was registered on step 0 randomized cohort * Patient was registered on step 0, targeted cohort however, must meet one of the following criteria: ** Patient did not have a known molecular alteration in ROS1, RET, or MET and did not have central review of tissue ** Central review report the patient is not eligible for Arm T based on molecular report * Patient was registered on Step 0, targeted cohort however, must meet one of the following criteria: ** Central review results report the patient is not eligible for Arm T ** Central review results report the patient is eligible for Arm T, but patient did not meet the additional eligibility criteria

  • ADDITIONAL ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION) ARMS A-C: Patient must not have had any prior anti-MET therapy, such as crizotinib or cabozantinib

  • ADDITIONAL ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION) ARMS A-C: Patient must not have had any prior allergic reaction or hypersensitivity to study drug components or related drugs (multitargeted small molecule tyrosine kinase inhibitors or checkpoint inhibitor monoclonal antibodies)

  • ADDITIONAL ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION) ARMS A-C: Patients must not have had history of life-threatening toxicity related to prior immune therapy (e.g. anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (e.g., hypo/hyperthyroidism)

  • ADDITIONAL ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION) TARGETED ARM T: Patient was registered to step 0, targeted arm and central review results report the patient is eligible for arm T

  • ADDITIONAL ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION) TARGETED ARM T: Patients with ROS1 gene rearrangements must have progressed on at least one prior ROS1 targeted therapy such as crizotinib

  • ADDITIONAL ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION) TARGETED ARM T: Patient must have progressed radiographically (per local investigator clinical assessment) on at least one line of prior chemotherapy or targeted therapy, but there is no limit on number of prior number. Prior immunotherapy is allowed but not required. Prior bevacizumab with chemo is allowed. * NOTE: The requirement for prior chemotherapy will be met if patients have recurrence within 6 months after prior adjuvant platinum based chemotherapy for early stage disease, or recurrence within 6 months after prior radiotherapy plus platinum based chemotherapy for locally advanced disease * NOTE: Patients with unresectable stage III NSCLC who have received chemo and radiation then consolidation durvalumab, followed by progression are eligible if progression happens after > 2 doses of durvalumab. Prior bevacizumab with chemo is also allowed

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Patients must have met all eligibility requirements for Step 1 at time of registration to Step 1 to be eligible for Step 2

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Patients must have radiographic progressive disease per RECIST criteria after >= 2 cycles of therapy on arm C

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Patients must not have intervening anticancer treatment or major surgical procedure(s) between step 1 and step 2, except palliative radiation to the bone finishing >= 1 week prior to registration to step 2

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Patients may not have central nervous system progression, but patients with stable CNS disease are allowed

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Patients must be registered to step 2 within 4 weeks of the last dose of treatment administration from step 1

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Patients must have an ECOG performance status between 0-2

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Patients must have recovered to baseline (pre-step 1) or Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Leukocytes >= 3,000/mcL (obtained within 2 weeks prior to randomization/registration)

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Absolute neutrophil count >= 1,500/mcL (obtained within 2 weeks prior to randomization/registration)

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Platelets >= 100,000/mcL (obtained within 2 weeks prior to randomization/registration)

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Hemoglobin >= 9 g/dL (obtained within 2 weeks prior to randomization/registration)

  • Total bilirubin =< 1.5 x institutional ULN (obtained within 2 weeks prior to randomization/registration)

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN (obtained within 2 weeks prior to randomization/registration)

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Creatinine =< 1.5 x ULN OR calculated (Cockcroft-Gault formula) or measured creatinine clearance >= 50 mL/min/1.73 m^2 (normalized to BSA) for patients with creatinine levels greater than 1.5 times the institutional normal creatinine =< 1.5 x ULN or creatinine clearance >= 50 ml/min/1.73 m^2 (obtained within 2 weeks prior to randomization/registration)

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before registration

  • STEP 2 ELIGIBILITY CRITERIA (CROSSOVER ARM Z): No intercurrent illness or disease complication that the investigator believes would limit the ability to safely tolerate the combination of cabozantinib and nivolumab

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
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Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
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Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Associates in Radiation Medicine
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Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
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Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Radiation Therapy Center
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Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
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Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
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Email: AKPAMC.OncologyResearchSupport@providence.org

Fairbanks
Fairbanks Memorial Hospital
Contact: Site Public Contact
Email: Veronica.Stevenson@foundationhealth.org

AL
Birmingham
Veterans Administration Medical Center - Birmingham
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

AR
Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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Email: ResearchInstituteInquiries@CommonSpirit.org

AZ
Goodyear
CTCA at Western Regional Medical Center
Contact: Site Public Contact

Kingman
Kingman Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Phoenix
Cancer Center at Saint Joseph's
Contact: Site Public Contact
Email: CancerInstitute@DignityHealth.org

Tucson
Banner University Medical Center - Tucson
Contact: Site Public Contact
Email: UACC-NCTN@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
Contact: Site Public Contact

CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

PCR Oncology
Contact: Site Public Contact
Email: research@sncrf.org

Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Contact: Site Public Contact
Email: Najee.Boucher@providence.org

Fremont
Washington Hospital
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Marysville
Fremont - Rideout Cancer Center
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Orange
Saint Joseph Hospital - Orange
Contact: Site Public Contact

Palo Alto
Stanford Cancer Institute Palo Alto
Contact: Site Public Contact
Email: ccto-office@stanford.edu

Sacramento
Mercy Cancer Center - Sacramento
Contact: Site Public Contact
Email: OncologyResearch@DignityHealth.org

University of California Davis Comprehensive Cancer Center
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San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Email: ResearchInstituteInquiries@CommonSpirit.org

Woodland
Woodland Memorial Hospital
Contact: Site Public Contact
Email: OncologyResearch@DignityHealth.org

CO
Aurora
Rocky Mountain Cancer Centers-Aurora
Contact: Site Public Contact
Email: info@westernstatesncorp.org

The Medical Center of Aurora
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Email: info@westernstatesncorp.org

Boulder
Boulder Community Foothills Hospital
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Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Boulder
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Email: info@westernstatesncorp.org

Centennial
Rocky Mountain Cancer Centers - Centennial
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Email: info@westernstatesncorp.org

Colorado Springs
Penrose-Saint Francis Healthcare
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Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
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Email: ResearchTracking@Centura.Org

Saint Francis Cancer Center
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Email: ResearchTracking@Centura.Org

Denver
Cancer Center of Colorado at Sloan's Lake
Contact: Site Public Contact

Colorado Blood Cancer Institute
Contact: Site Public Contact
Email: info@westernstatesncorp.org

National Jewish Health-Main Campus
Contact: Site Public Contact
Email: glicht@co-cancerresearch.org

Porter Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Presbyterian - Saint Lukes Medical Center - Health One
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Midtown
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Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Rose
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Rose Medical Center
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Email: ccrp@co-cancerresearch.org

SCL Health Saint Joseph Hospital
Contact: Site Public Contact
Email: alan.franklin@sclhealth.org

The Women's Imaging Center
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Western Surgical Care
Contact: Site Public Contact

Durango
Mercy Medical Center
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Email: ResearchTracking@Centura.Org

Southwest Oncology PC
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Email: ResearchTracking@Centura.Org

Englewood
Mountain Blue Cancer Care Center - Swedish
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Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers - Swedish
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Email: info@westernstatesncorp.org

Swedish Medical Center
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Email: info@westernstatesncorp.org

The Melanoma and Skin Cancer Institute
Contact: Site Public Contact
Email: ryan.weight@theskincancerinstitute.com

Fort Collins
Cancer Care and Hematology-Fort Collins
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Poudre Valley Hospital
Contact: Site Public Contact

Golden
National Jewish Health-Western Hematology Oncology
Contact: Site Public Contact
Email: glicht@co-cancerresearch.org

Grand Junction
Saint Mary's Hospital and Regional Medical Center
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

Greeley
North Colorado Medical Center
Contact: Site Public Contact
Email: info@westernstatesncorp.org

UCHealth Greeley Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Highlands Ranch
UCHealth Highlands Ranch Hospital
Contact: Site Public Contact

Lafayette
Good Samaritan Medical Center
Contact: Site Public Contact

Lakewood
Rocky Mountain Cancer Centers-Lakewood
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Saint Anthony Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Littleton
Littleton Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Littleton
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Sky Ridge Medical Center
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Longmont
Longmont United Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Longmont
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Loveland
McKee Medical Center
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Medical Center of the Rockies
Contact: Site Public Contact

Parker
Parker Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Pueblo
Saint Mary Corwin Medical Center
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Thornton
National Jewish Health-Northern Hematology Oncology
Contact: Site Public Contact
Email: glicht@co-cancerresearch.org

Rocky Mountain Cancer Centers-Thornton
Contact: Site Public Contact
Email: info@westernstatesncorp.org

CT
West Haven
Veterans Affairs Connecticut Healthcare System-West Haven Campus
Contact: Site Public Contact

FL
Aventura
Mount Sinai Comprehensive Cancer Center at Aventura
Contact: Site Public Contact
Email: yenrique@msmc.com

Fort Lauderdale
Holy Cross Hospital
Contact: Site Public Contact

Miami Beach
Mount Sinai Medical Center
Contact: Site Public Contact
Email: yenrique@msmc.com

GA
Atlanta
Emory University Hospital Midtown
Contact: Site Public Contact

Emory University Hospital/Winship Cancer Institute
Contact: Site Public Contact

Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Contact: Site Public Contact
Email: underberga@sjchs.org

IA
Ames
Mary Greeley Medical Center
Contact: Site Public Contact

McFarland Clinic PC - Ames
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com

Bettendorf
University of Iowa Healthcare Cancer Services Quad Cities
Contact: Site Public Contact
Email: kedaprile@rccqc.com

Boone
McFarland Clinic PC-Boone
Contact: Site Public Contact

Carroll
Saint Anthony Regional Hospital
Contact: Site Public Contact
Email: sbenson@iora.org

Clive
Medical Oncology and Hematology Associates-West Des Moines
Contact: Site Public Contact

Mercy Cancer Center-West Lakes
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Council Bluffs
Alegent Health Mercy Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Heartland Oncology and Hematology LLP
Contact: Site Public Contact

Jennie Edmundson Memorial Hospital
Contact: Site Public Contact
Email: ctsucontact@westat.com

Creston
Greater Regional Medical Center
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
Contact: Site Public Contact

Iowa Lutheran Hospital
Contact: Site Public Contact

Iowa Methodist Medical Center
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Des Moines
Contact: Site Public Contact

Mercy Medical Center - Des Moines
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
Contact: Site Public Contact

Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Contact: Site Public Contact

Trinity Regional Medical Center
Contact: Site Public Contact

Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Contact: Site Public Contact

Jefferson
McFarland Clinic PC-Jefferson
Contact: Site Public Contact

Marshalltown
McFarland Clinic PC-Marshalltown
Contact: Site Public Contact

West Des Moines
Mercy Medical Center-West Lakes
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
Contact: Site Public Contact

ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Contact: Site Public Contact
Email: eslinget@slhs.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Emmett
Walter Knox Memorial Hospital
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Idaho Urologic Institute-Meridian
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Meridian
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Alphonsus Medical Center-Nampa
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Contact: Site Public Contact
Email: eslinget@slhs.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
Contact: Site Public Contact

Aurora
Rush - Copley Medical Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

Barrington
Advocate Good Shepherd Hospital
Contact: Site Public Contact

Bloomington
Illinois CancerCare-Bloomington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Chicago
Advocate Illinois Masonic Medical Center
Contact: Site Public Contact

University of Illinois
Contact: Site Public Contact

Crystal Lake
AMG Crystal Lake - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocate.com

Danville
Carle on Vermilion
Contact: Site Public Contact
Email: Research@carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Contact: Site Public Contact

Downers Grove
Advocate Good Samaritan Hospital
Contact: Site Public Contact
Email: Barbara.barhamand@advocatehealth.com

Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Elgin
Advocate Sherman Hospital
Contact: Site Public Contact

Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Contact: Site Public Contact

Hazel Crest
Advocate South Suburban Hospital
Contact: Site Public Contact

Hines
Edward Hines Jr VA Hospital
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Libertyville
AMG Libertyville - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com

Condell Memorial Hospital
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com

Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com

Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact

O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Oak Lawn
Advocate Christ Medical Center
Contact: Site Public Contact

Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Park Ridge
Advocate Lutheran General Hospital
Contact: Site Public Contact

Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Rockford
SwedishAmerican Regional Cancer Center/ACT
Contact: Site Public Contact
Email: cancercare@swedishamerican.org

Springfield
Memorial Medical Center
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Contact: Site Public Contact

Springfield Clinic
Contact: Site Public Contact

Swansea
Southwest Illinois Health Services LLP
Contact: Site Public Contact
Email: lynns@thecancercenter.com

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com

Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

IN
Richmond
Reid Health
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

South Bend
Memorial Hospital of South Bend
Contact: Site Public Contact

KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org

Hays
HaysMed University of Kansas Health System
Contact: Site Public Contact

Lawrence
Lawrence Memorial Hospital
Contact: Site Public Contact
Email: Stephanie.Norris@LMH.ORG

Olathe
Olathe Health Cancer Center
Contact: Site Public Contact
Email: Jeni.wakefield@olathehealth.org

Overland Park
Saint Luke's South Hospital
Contact: Site Public Contact
Email: aroland@kccop.org

Pittsburg
Ascension Via Christi - Pittsburg
Contact: Site Public Contact
Email: jennifer.jameson@ascension.org

Salina
Salina Regional Health Center
Contact: Site Public Contact
Email: mleepers@srhc.com

Topeka
University of Kansas Health System Saint Francis Campus
Contact: Site Public Contact

KY
Bardstown
Flaget Memorial Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Saint Joseph Hospital East
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

London
Saint Joseph London
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Louisville
Jewish Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saints Mary and Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UofL Health Medical Center Northeast
Contact: Site Public Contact
Email: ctoinfo@louisville.edu

Mount Sterling
Saint Joseph Mount Sterling
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Owensboro
Owensboro Health Mitchell Memorial Cancer Center
Contact: Site Public Contact
Email: vanissa.sorrels@owensborohealth.org

Shepherdsville
Jewish Hospital Medical Center South
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
Contact: Site Public Contact
Email: research@ololrmc.com

Louisiana Hematology Oncology Associates LLC
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Mary Bird Perkins Cancer Center
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Our Lady of The Lake
Contact: Site Public Contact

Our Lady of the Lake Physicians Group - Medical Oncology
Contact: Site Public Contact
Email: research@ololrmc.com

Covington
Northshore Oncology Associates-Covington
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Houma
Terrebonne General Medical Center
Contact: Site Public Contact
Email: ann.hooks@tgmc.com

MA
Boston
Boston Medical Center
Contact: Site Public Contact

Worcester
UMass Memorial Medical Center - University Campus
Contact: Site Public Contact
Email: cancer.research@umassmed.edu

MD
Baltimore
Saint Agnes Hospital
Contact: Site Public Contact

ME
Augusta
Harold Alfond Center for Cancer Care
Contact: Site Public Contact

Biddeford
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Contact: Site Public Contact
Email: LLemire@mmc.org

Sanford
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Contact: Site Public Contact
Email: LLemire@mmc.org

South Portland
Maine Medical Partners - South Portland
Contact: Site Public Contact
Email: ClinicalResearch@mmc.org

MI
Adrian
Hickman Cancer Center
Contact: Site Public Contact

Ann Arbor
Saint Joseph Mercy Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Battle Creek
Bronson Battle Creek
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Brighton
Saint Joseph Mercy Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Saint Joseph Mercy Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Caro
Caro Cancer Center
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Chelsea
Saint Joseph Mercy Chelsea
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Clarkston
Hematology Oncology Consultants-Clarkston
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Detroit
Ascension Saint John Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

East China
Great Lakes Cancer Management Specialists-Doctors Park
Contact: Site Public Contact
Email: karen.forman@ascension.org

Flint
Genesee Cancer and Blood Disease Treatment Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesee Hematology Oncology PC
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
Contact: Site Public Contact
Email: wstrong@ghci.org

Hurley Medical Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Grosse Pointe Woods
Academic Hematology Oncology Specialists
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Grosse Pointe Woods
Contact: Site Public Contact
Email: karen.forman@ascension.org

Kalamazoo
Ascension Borgess Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Borgess Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Lansing
Sparrow Hospital
Contact: Site Public Contact

Livonia
Hope Cancer Clinic
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Macomb Township
Contact: Site Public Contact
Email: karen.forman@ascension.org

Marlette
Saint Mary's Oncology/Hematology Associates of Marlette
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Monroe
Toledo Clinic Cancer Centers-Monroe
Contact: Site Public Contact

Muskegon
Trinity Health Muskegon Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Niles
Lakeland Hospital Niles
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Novi
Ascension Providence Hospitals - Novi
Contact: Site Public Contact
Email: karen.fife@ascension.org

Pontiac
21st Century Oncology-Pontiac
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Hope Cancer Center
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Pontiac
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Oakland
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Reed City
Spectrum Health Reed City Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saginaw
Ascension Saint Mary's Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Oncology Hematology Associates of Saginaw Valley PC
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Saint Joseph
Lakeland Medical Center Saint Joseph
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Marie Yeager Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Southfield
Ascension Providence Hospitals - Southfield
Contact: Site Public Contact
Email: karen.fife@ascension.org

Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Contact: Site Public Contact
Email: karen.forman@ascension.org

Tawas City
Ascension Saint Joseph Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Traverse City
Munson Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Warren
Advanced Breast Care Center PLLC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Macomb Professional Building
Contact: Site Public Contact
Email: karen.forman@ascension.org

Macomb Hematology Oncology PC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Warren
Contact: Site Public Contact
Email: karen.forman@ascension.org

Saint John Macomb-Oakland Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

West Branch
Saint Mary's Oncology/Hematology Associates of West Branch
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Wyoming
Metro Health Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Ypsilanti
Huron Gastroenterology PC
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

MN
Aitkin
Riverwood Healthcare Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Baxter
Essentia Health - Baxter Clinic
Contact: Site Public Contact

Brainerd
Essentia Health Saint Joseph's Medical Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Burnsville
Fairview Ridges Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Cambridge
Cambridge Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Deer River
Essentia Health - Deer River Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Detroit Lakes
Essentia Health Saint Mary's - Detroit Lakes Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Duluth
Essentia Health Cancer Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's Medical Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Miller-Dwan Hospital
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Edina
Fairview Southdale Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Ely
Essentia Health - Ely Clinic
Contact: Site Public Contact

Fergus Falls
Lake Region Healthcare Corporation-Cancer Care
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Fosston
Essentia Health - Fosston
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Fridley
Unity Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hibbing
Essentia Health Hibbing Clinic
Contact: Site Public Contact

International Falls
Essentia Health - International Falls Clinic
Contact: Site Public Contact

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hennepin County Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Moose Lake
Essentia Health - Moose Lake Clinic
Contact: Site Public Contact

New Ulm
New Ulm Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Park Rapids
Essentia Health - Park Rapids
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Princeton
Fairview Northland Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Sandstone
Essentia Health Sandstone
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Shakopee
Saint Francis Regional Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Virginia
Essentia Health Virginia Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Waconia
Ridgeview Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Wyoming
Fairview Lakes Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org

Branson
Cox Cancer Center Branson
Contact: Site Public Contact

Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Contact: Site Public Contact

Columbia
University of Missouri - Ellis Fischel
Contact: Site Public Contact

Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Kansas City
Saint Luke's Hospital of Kansas City
Contact: Site Public Contact
Email: aroland@kccop.org

Truman Medical Centers
Contact: Site Public Contact

Lee's Summit
Saint Luke's East - Lee's Summit
Contact: Site Public Contact
Email: aroland@kccop.org

Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: janet.lesko@mercy.net

Missouri Baptist Medical Center
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact

Siteman Cancer Center at Christian Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Siteman Cancer Center-South County
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Washington University School of Medicine
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Contact: Site Public Contact

MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org

Saint Vincent Frontier Cancer Center
Contact: Site Public Contact

Saint Vincent Healthcare
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bozeman
Bozeman Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: amy.hanneman@providence.org

NC
Kenansville
Vidant Oncology-Kenansville
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com

Kinston
Vidant Oncology-Kinston
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com

Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Contact: Site Public Contact
Email: jcwilliams@firsthealth.org

Richlands
Vidant Oncology-Richlands
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com

Washington
Marion L Shepard Cancer Center at Vidant Beaufort Hospital
Contact: Site Public Contact

ND
Fargo
Essentia Health Cancer Center-South University Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Jamestown
Essentia Health - Jamestown Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

NE
Bellevue
Nebraska Medicine-Bellevue
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

Grand Island
CHI Health Saint Francis
Contact: Site Public Contact

Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lincoln
Saint Elizabeth Regional Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Nebraska Medicine-Village Pointe
Contact: Site Public Contact

Nebraska Methodist Hospital
Contact: Site Public Contact

Oncology Associates PC
Contact: Site Public Contact
Email: info@oa-oc.com

University of Nebraska Medical Center
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

NH
Concord
New Hampshire Oncology Hematology PA-Concord
Contact: Site Public Contact

Manchester
Elliot Hospital
Contact: Site Public Contact

Solinsky Center for Cancer Care
Contact: Site Public Contact

NJ
Moorestown
Virtua Samson Cancer Center
Contact: Site Public Contact

Mount Holly
Virtua Memorial
Contact: Site Public Contact

Voorhees
Virtua Voorhees
Contact: Site Public Contact

NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: LByatt@nmcca.org

NV
Carson City
Carson Tahoe Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Henderson
Cancer and Blood Specialists-Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Green Valley
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pebble
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Seven Hills
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Green Valley
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Contact: Site Public Contact
Email: research@sncrf.org

Ann M Wierman MD LTD
Contact: Site Public Contact
Email: research@sncrf.org

Cancer and Blood Specialists-Shadow
Contact: Site Public Contact
Email: research@sncrf.org

Cancer and Blood Specialists-Tenaya
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Contact: Site Public Contact
Email: research@sncrf.org

Desert West Surgery
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Las Vegas
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Vegas Tenaya
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-San Martin
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Contact: Site Public Contact
Email: research@sncrf.org

Hope Cancer Care of Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Prostate Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Cathedral Rock
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pecos
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Smoke Ranch
Contact: Site Public Contact
Email: research@smcrf.org

Las Vegas Urology - Sunset
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Charleston
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at MountainView
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Central
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Contact: Site Public Contact
Email: research@sncrf.org

Summerlin Hospital Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Sunrise Hospital and Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

University Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org

University Medical Center of Southern Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Central
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Northwest
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Southwest
Contact: Site Public Contact
Email: research@sncrf.org

Pahrump
Hope Cancer Care of Nevada-Pahrump
Contact: Site Public Contact
Email: research@sncrf.org

Reno
Radiation Oncology Associates
Contact: Site Public Contact
Email: research@sncrf.org

Renown Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Saint Mary's Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

NY
Bronx
Montefiore Medical Center - Moses Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org

Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
Contact: Site Public Contact
Email: eskwak@montefiore.org

Glens Falls
Glens Falls Hospital
Contact: Site Public Contact

OH
Alliance
Aultman Alliance Community Hospital
Contact: Site Public Contact

Beavercreek
Indu and Raj Soin Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Boardman
Saint Elizabeth Boardman Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Canton
Aultman Health Foundation
Contact: Site Public Contact
Email: ClinicalReserachDept@aultman.com

Cleveland Clinic Mercy Hospital
Contact: Site Public Contact

Mercy Hematology and Oncology Associates Inc
Contact: Site Public Contact

Centerville
Dayton Physicians LLC-Miami Valley South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Oncology Hematology Care Inc-Kenwood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Cleveland Clinic Foundation
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Dayton
Dayton Physician LLC-Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Findlay
Armes Family Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Orion Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greenville
Dayton Physicians LLC-Wayne
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Wayne Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering
First Dayton Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greater Dayton Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Mansfield
Cleveland Clinic Cancer Center Mansfield
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Mayfield Heights
Hillcrest Hospital Cancer Center
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Perrysburg
Mercy Health Perrysburg Cancer Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Sandusky
North Coast Cancer Care
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Springfield
Springfield Regional Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield Regional Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Toledo
Mercy Health - Saint Anne Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Toledo Clinic Cancer Centers-Toledo
Contact: Site Public Contact

Troy
Dayton Physicians LLC - Troy
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

WPAFB
Wright-Patterson Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Warrensville Heights
South Pointe Hospital
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Youngstown
Saint Elizabeth Youngstown Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

OR
Baker City
Saint Alphonsus Medical Center-Baker City
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bend
Saint Charles Health System
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Ontario
Saint Alphonsus Medical Center-Ontario
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Portland
Oregon Health and Science University
Contact: Site Public Contact
Email: trials@ohsu.edu

Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Contact: Site Public Contact

PA
Allentown
Lehigh Valley Hospital-Cedar Crest
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Saint Luke's Cancer Center - Allentown
Contact: Site Public Contact

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Saint Luke's University Hospital-Bethlehem Campus
Contact: Site Public Contact

Bryn Mawr
Bryn Mawr Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Chambersburg
Chambersburg Hospital
Contact: Site Public Contact
Email: ctsucontact@westat.com

WellSpan Medical Oncology and Hematology
Contact: Site Public Contact

Collegeville
Main Line Health Center-Collegeville
Contact: Site Public Contact
Email: turzoe@mlhs.org

East Stroudsburg
Pocono Medical Center
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Easton
Saint Luke's Hospital-Anderson Campus
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Ephrata
Ephrata Cancer Center
Contact: Site Public Contact

Exton
Main Line Health Center-Exton
Contact: Site Public Contact
Email: turzoe@mlhs.org

Gettysburg
Adams Cancer Center
Contact: Site Public Contact

Hanover
Cherry Tree Cancer Center
Contact: Site Public Contact

Hazleton
Lehigh Valley Hospital-Hazleton
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Lebanon
Sechler Family Cancer Center
Contact: Site Public Contact
Email: doxenberg@wellspan.org

Media
Riddle Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Newtown Square
Bryn Mawr Health Center
Contact: Site Public Contact
Email: turzoe@mlhs.org

Paoli
Paoli Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Philadelphia
Penn Presbyterian Medical Center
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact

Pottstown
Pottstown Hospital
Contact: Site Public Contact

Quakertown
Saint Luke's Hospital-Quakertown Campus
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Sayre
Guthrie Medical Group PC-Robert Packer Hospital
Contact: Site Public Contact

Wynnewood
Lankenau Medical Center
Contact: Site Public Contact
Email: turzoe@mlhs.org

York
Cancer Care Associates of York
Contact: Site Public Contact

WellSpan Health-York Cancer Center
Contact: Site Public Contact

WellSpan Health-York Hospital
Contact: Site Public Contact

SC
Greenwood
Self Regional Healthcare
Contact: Site Public Contact
Email: nmcgaha@selfregional.org

TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

VA
Mechanicsville
Bon Secours Memorial Regional Medical Center
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org

Midlothian
Bon Secours Saint Francis Medical Center
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org

Bon Secours Westchester Emergency Center
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org

Norfolk
Bon Secours DePaul Medical Center
Contact: Site Public Contact
Email: Marylou_Anton@bshsi.org

Portsmouth
Bon Secours Maryview Medical Center
Contact: Site Public Contact
Email: Marylou_Anton@bshsi.org

Richmond
Bon Secours Cancer Institute at Reynolds Crossing
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org

Bon Secours Saint Mary's Hospital
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org

VCU Massey Cancer Center at Stony Point
Contact: Site Public Contact
Email: ctoclinops@vcu.edu

Virginia Commonwealth University/Massey Cancer Center
Contact: Site Public Contact
Email: CTOclinops@vcu.edu

Suffolk
Bon Secours Health Center at Harbour View
Contact: Site Public Contact
Email: Marylou_Anton@bshsi.org

WI
Appleton
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Ashland
Duluth Clinic Ashland
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Northwest Wisconsin Cancer Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: ncorp@aurora.org

Chippewa Falls
Marshfield Clinic-Chippewa Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Cudahy
Aurora Saint Luke's South Shore
Contact: Site Public Contact
Email: ncorp@aurora.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Germantown
Aurora Health Care Germantown Health Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org

Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Hayward
Essentia Health-Hayward Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Kenosha
Aurora Cancer Care-Kenosha South
Contact: Site Public Contact
Email: ncorp@aurora.org

La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Ladysmith
Marshfield Clinic - Ladysmith Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: ncorp@aurora.org

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Milwaukee
Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Sinai Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Mukwonago
ProHealth D N Greenwald Center
Contact: Site Public Contact
Email: research.institute@phci.org

New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact

Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org

Racine
Aurora Cancer Care-Racine
Contact: Site Public Contact
Email: ncorp@aurora.org

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org

Spooner
Essentia Health-Spooner Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org

Superior
Essentia Health Saint Mary's Hospital - Superior
Contact: Site Public Contact

Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org

Waukesha
ProHealth Waukesha Memorial Hospital
Contact: Site Public Contact

UW Cancer Center at ProHealth Care
Contact: Site Public Contact
Email: Chanda.miller@phci.org

Wausau
Marshfield Clinic-Wausau Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wauwatosa
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

WV
Huntington
Edwards Comprehensive Cancer Center
Contact: Site Public Contact
Email: Christina.Cole@chhi.org

WY
Cheyenne
Cheyenne Regional Medical Center-West
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

Cody
Billings Clinic-Cody
Contact: Site Public Contact
Email: research@billingsclinic.org

Sheridan
Welch Cancer Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

PRIMARY OBJECTIVE:
I. To determine whether cabozantinib alone, or the combination of nivolumab and cabozantinib, as compared to standard chemotherapy alone, extends progression-free survival (PFS) for this patient population with non squamous NSCLC.

SECONDARY OBJECTIVES:
I. To evaluate the progression free survival (PFS) and best overall radiographic response rate of the targeted therapy arm of the trial.
II. To determine the overall survival for each arm of the trial.
III. To evaluate the best overall radiographic response rate for each arm of the trial.
IV. To evaluate and describe the toxicity profile of monotherapy with cabozantinib, and the combination of nivolumab and cabozantinib in this patient population with non-squamous NSCLC.

EXPLORATORY IMAGING OBJECTIVES:
I. To describe time point tumor response assessment, overall best response, progression-free survival and overall survival using the conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and the exploratory revised CHOI criteria with all measurements performed by the central review.
II. To compare the progression-free survival using the RECIST1.1 imaging response assessment measurements by site study personnel to those performed by central review.

EXPLORATORY CORRELATIVE OBJECTIVE:
I. To perform correlative biomarker research on tissue and blood biospecimens collected within this trial.

OUTLINE: Patients without known molecular alterations are randomly assigned to 1 of 3 arms. Patients with known molecular alterations are assigned to Arm B.

ARM A: Patients receive cabozantinib S-malate orally (PO) once daily (QD). Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients may continue to receive therapy after investigator-assessed RECIST 1.1 defined progression, including stable clinical and performance status and have potential for continued clinical benefit.

ARM B: Patients receive cabozantinib S-malate PO QD and nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients may continue to receive therapy after investigator-assessed RECIST 1.1 defined progression, including stable clinical and performance status and have potential for continued clinical benefit.

ARM C:
STEP 1: Patients receive ramucirumab IV over 30-60 minutes and docetaxel IV over 1 hour on day 1, or docetaxel IV over 1 hour on day 1 or on days 1 and 8, or gemcitabine hydrochloride IV on days 1 and 8, or paclitaxel IV over 3 hours on day 1, or nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity and at the discretion of the treating physician. Patients may continue to receive therapy after investigator-assessed RECIST 1.1 defined progression, including stable clinical and performance status and have potential for continued clinical benefit.

STEP 2: Patients receive cabozantinib S-malate PO QD and nivolumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients may continue to receive therapy after investigator-assessed RECIST 1.1 defined progression, including stable clinical and performance status and have potential for continued clinical benefit.

After the completion of study treatment, patients are followed up every 3 months for up to 3 years.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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