Melanoma (Skin Cancer)

EA6192 / PET-Stop



Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients with Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial

STATUS: Active


This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy.
  • STEP 0 PRE-REGISTRATION INCLUSION CRITERIA

  • Patient must be >= 18 years of age

  • Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition. Patients with mucosal melanoma defined as unresectable stage III or regional/distant metastatic disease are eligible

  • Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible. Patients must not have melanoma from an ocular primary site

  • Patient must have had measurable disease by immune related Response Evaluation Criteria in Solid Tumors (imRECIST) prior to start of initial anti-PD-1 therapy

  • Patient must be actively receiving standard of care anti-PD-1 therapy, currently be 52 weeks (+/- 2 weeks) from start of anti-PD-1 therapy, and have not experienced a toxicity that prevents them from continuing on therapy. Patients are not required to complete all four induction doses of nivolumab/ipilimumab or pembrolizumab/ipilimumab if they continued to receive anti-PD-1 monotherapy. Weight based anti-PD-1 dosing is permitted in place of flat dosing. Permitted systemic anti-PD-1 therapy regimens include: * Nivolumab 240 mg IV every (Q)2weeks or 480 mg IV Q4weeks * Pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks * Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance * Nivolumab 3 mg/kg plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance * Pembrolizumab 2 mg/kg (or 200 mg flat dose) plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks maintenance *โ€ขNivolumab 480mg / Relatlimab 160mg FDC IV Q4weeks

  • Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients who are receiving bisphosphonates and RANKL inhibitors for management of bone metastases are eligible

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients with detectable viral loads are excluded as it is unclear if these patients have a low risk of melanoma progression off anti-PD-1 treatment

  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • Patients with a 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

  • Patients with baseline brain metastases must have been treated with surgery and/or stereotactic radiosurgery and demonstrate disease control or response. Alternatively, patients with baseline brain metastases primarily treated with systemic therapy must demonstrate ongoing response/disease control. Patients with emergent or progressive brain metastases after start of systemic therapy are not eligible. Brain imaging (magnetic resonance imaging [MRI] with IV contrast preferred; non-contrast MRI or contrast enhanced computed tomography [CT] scan are acceptable) at week 48 (+/- 6 weeks) to confirm disease control/response is required in patients with known brain metastasis history

  • 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 are eligible for this trial

  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better

  • Patient must have experienced complete response, partial response, or stable disease on restaging CT scans by imRECIST that is maintained on diagnostic restaging scans by immune mediated response evaluation criteria in solid tumors (imRECIST) that is maintained on the PET/CT scan at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy

  • Patient must have completed an FDG-PET/CT scan at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy * Patients with FDG PET/CT positive for hypermetabolic lesions: If a core needle, punch or excisional biopsy and pathological review of a representative lesion was not performed prior to pre-registration (Step 0) must either: ** Be amenable to undergo a biopsy. Patient must not be on anticoagulation therapy or, if on anti-coagulation therapy, patient must be able to hold treatment for a biopsy procedure (core needle, punch or excisional biopsy). Anti-coagulation therapy is defined as low molecular weight heparin, warfarin, factor Xa inhibitor, or direct thrombin inhibitor ** Have documentation of inability to perform the biopsy due to feasibility or safety concerns

  • Patients must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the anti-PD-1 regimens being used. All patients of childbearing potential must have a blood test or urine study within 28 days prior to Step 0 pre-registration to rule out pregnancy. A second pregnancy test for patients registered to Arm A may be done as clinically indicated. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) 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)

  • Patients must not conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of study registration and continuing (for patients of childbearing potential) until at least 5 months after the last dose of anti-PD-1 treatment. Patients of childbearing potential must also not donate eggs during this same time period

  • Leukocytes >= 3,000/mcL (obtained =< 4 weeks prior to protocol registration)

  • Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 4 weeks prior to protocol registration)

  • Platelets >= 100,000/mcL (obtained =< 4 weeks prior to protocol registration)

  • Total bilirubin =< institutional upper limit of normal (ULN) (patients with history of Gilbertโ€™s syndrome are permitted to have a total bilirubin > 1.5 x institutional ULN) (obtained =< 4 weeks prior to protocol registration)

  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 4 weeks prior to protocol registration)

  • Creatinine =< 1.5 x institutional ULN (obtained =< 4 weeks prior to protocol registration)

  • STEP 1 REGISTRATION INCLUSION CRITERIA

  • Patient met all eligibility criteria outlined above

  • Patient must register to Step 1 within 4 weeks of registration to Step 0

  • Patients must meet one of the following criteria: * Patient had no positive hypermetabolic lesions on the week 52 FDG-PET/CT. * Patients with positive hypermetabolic lesion(s) on the week 52 FDG-PET/CT (positive hypermetabolic = standard uptake volume [SUV] > pooled mediastinal blood), one of the following must have occurred: ** A representative lesion was biopsied (core needle, punch or excisional biopsy) and subsequent pathology review performed to determine the presence or absence of viable tumor within 28 days of registration to Step 0 ** Documentation is present that the patient is not able to undergo biopsy of a hypermetabolic lesion due to feasibility or safety concerns, i.e., the lesion location that is not amenable to biopsy

United States
AK
Fairbanks
Fairbanks Memorial Hospital
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Email: Veronica.Stevenson@foundationhealth.org

AL
Fairhope
Thomas Hospital
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Mobile
Mobile Infirmary Medical Center
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AR
Ft. Smith
Mercy Hospital Fort Smith
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Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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Email: ResearchInstituteInquiries@CommonSpirit.org

Little Rock
CARTI Cancer Center
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Email: Research@CARTI.com

University of Arkansas for Medical Sciences
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AZ
Phoenix
Cancer Center at Saint Joseph's
Contact: Site Public Contact
Email: Research-cancerinstitute@dignityhealth.org

Tucson
Banner University Medical Center - Tucson
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Email: UACC-IIT@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
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Email: UACC-IIT@uacc.arizona.edu

CA
Antioch
Kaiser Permanente-Deer Valley Medical Center
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Email: Kpoct@kp.org

Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Email: ResearchInstituteInquiries@CommonSpirit.org

Carmichael
Mercy Cancer Center ๏ฟฝ๏ฟฝ Carmichael
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Email: ecog.rss@jimmy.harvard.edu

Mercy San Juan Medical Center
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Email: OncologyResearch@DignityHealth.org

Dublin
Kaiser Permanente Dublin
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Elk Grove
Mercy Cancer Center - Elk Grove
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Email: OncologyResearch@DignityHealth.org

Fremont
Kaiser Permanente-Fremont
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Email: Kpoct@kp.org

Fresno
Fresno Cancer Center
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Email: Kpoct@kp.org

Kaiser Permanente-Fresno
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Email: Kpoct@kp.org

Los Angeles
Cedars Sinai Medical Center
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The Angeles Clinic and Research Institute - West Los Angeles Office
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Email: ecog.rss@jimmy.harvard.edu

Modesto
Kaiser Permanente-Modesto
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Oakland
Kaiser Permanente Oakland-Broadway
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Email: Kpoct@kp.org

Kaiser Permanente-Oakland
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Email: Kpoct@kp.org

Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
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Email: Kpoct@kp.org

Redwood City
Kaiser Permanente- Marshall Medical Offices
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Richmond
Kaiser Permanente-Richmond
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Email: Kpoct@kp.org

Rocklin
Mercy Cancer Center - Rocklin
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Email: OncologyResearch@DignityHealth.org

Rohnert Park
Rohnert Park Cancer Center
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Email: Kpoct@kp.org

Roseville
Kaiser Permanente-Roseville
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Email: Kpoct@kp.org

The Permanente Medical Group-Roseville Radiation Oncology
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Email: Kpoct@kp.org

Sacramento
Kaiser Permanente Downtown Commons
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Email: kpoct@kp.org

Kaiser Permanente-South Sacramento
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Email: Kpoct@kp.org

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

South Sacramento Cancer Center
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Email: Kpoct@kp.org

San Francisco
Kaiser Permanente-San Francisco
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Email: Kpoct@kp.org

San Jose
Kaiser Permanente-Santa Teresa-San Jose
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Email: Kpoct@kp.org

San Leandro
Kaiser Permanente San Leandro
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Email: Kpoct@kp.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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Email: ResearchInstituteInquiries@CommonSpirit.org

San Rafael
Kaiser San Rafael-Gallinas
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Email: Kpoct@kp.org

Santa Clara
Kaiser Permanente Medical Center - Santa Clara
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Email: Kpoct@kp.org

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

Santa Rosa
Kaiser Permanente-Santa Rosa
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Email: Kpoct@kp.org

South San Francisco
Kaiser Permanente Cancer Treatment Center
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Email: Kpoct@kp.org

Kaiser Permanente-South San Francisco
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Email: Kpoct@kp.org

Stockton
Kaiser Permanente-Stockton
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Email: Kpoct@kp.org

Vacaville
Kaiser Permanente Medical Center-Vacaville
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Email: Kpoct@kp.org

Vallejo
Kaiser Permanente-Vallejo
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Email: Kpoct@kp.org

Walnut Creek
Kaiser Permanente-Walnut Creek
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Email: Kpoct@kp.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
Contact: Site Public Contact
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
Colorado Blood Cancer Institute
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Email: info@westernstatesncorp.org

Kaiser Permanente-Franklin
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Email: kristi.m.bronkan@kp.org

Porter Adventist Hospital
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Email: ResearchTracking@Centura.Org

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

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

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

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

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

Western Surgical Care
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Durango
Mercy Medical Center
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Email: ResearchTracking@Centura.Org

Southwest Oncology PC
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

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

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

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

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

Lafayette
Kaiser Permanente-Rock Creek
Contact: Site Public Contact
Email: kristi.m.bronkan@kp.org

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
Kaiser Permanente-Lone Tree
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Email: kristi.m.bronkan@kp.org

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

Sky Ridge Medical Center
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Email: info@westernstatesncorp.org

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

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

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

DC
Washington
MedStar Georgetown University Hospital
Contact: Site Public Contact

MedStar Washington Hospital Center
Contact: Site Public Contact

FL
Aventura
UM Sylvester Comprehensive Cancer Center at Aventura
Contact: Site Public Contact

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Contact: Site Public Contact

Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Contact: Site Public Contact

Fort Lauderdale
Holy Cross Hospital
Contact: Site Public Contact

Miami
UM Sylvester Comprehensive Cancer Center at Kendall
Contact: Site Public Contact

University of Miami Miller School of Medicine-Sylvester Cancer Center
Contact: Site Public Contact

Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Contact: Site Public Contact

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

Northside Hospital
Contact: Site Public Contact
Email: ClinicalTrials@northside.com

Duluth
Northside Hospital - Duluth
Contact: Site Public Contact
Email: Clinical.trials@northside.com

Lawrenceville
Northside Hospital - Gwinnett
Contact: Site Public Contact
Email: Clinical.trials@northside.com

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

HI
Honolulu
Kaiser Permanente Moanalua Medical Center
Contact: Site Public Contact
Email: shelley.a.clark@kp.org

IA
Ames
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic - 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

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
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Iowa Methodist Medical Center
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Medical Oncology and Hematology Associates-Des Moines
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Mercy Medical Center - Des Moines
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Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
Contact: Site Public Contact

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

Trinity Regional Medical Center
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Jefferson
McFarland Clinic - Jefferson
Contact: Site Public Contact

Marshalltown
McFarland Clinic - 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

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

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

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

Saint Mary's Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Chicago
Northwestern University
Contact: Site Public Contact
Email: cancer@northwestern.edu

University of Illinois
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Danville
Carle at The Riverfront
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

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

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

Galesburg
Illinois CancerCare-Galesburg
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Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Contact: Site Public Contact

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

Lake Forest
Northwestern Medicine Lake Forest Hospital
Contact: Site Public Contact
Email: cancertrials@northwestern.edu

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

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

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

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

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

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

Paducah
Mercy Health - Paducah Medical Oncology and Hematology
Contact: Site Public Contact
Email: BJWarner@mercy.com

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

MA
Boston
Boston Medical Center
Contact: Site Public Contact

MD
Baltimore
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Contact: Site Public Contact

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

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

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
University of Michigan Health - West
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

Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

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

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

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

Hibbing
Essentia Health Hibbing Clinic
Contact: Site Public Contact

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

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

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

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

Thief River Falls
Sanford Thief River Falls Medical Center
Contact: Site Public Contact

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

Worthington
Sanford Cancer Center Worthington
Contact: Site Public Contact

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

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

Osage Beach
Lake Regional Hospital
Contact: Site Public Contact
Email: clinicaltrials@lakeregional.com

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: Danielle.Werle@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

NC
Cary
Duke Cancer Institute Cary
Contact: Site Public Contact

Durham
Duke University Medical Center
Contact: Site Public Contact

Raleigh
Duke Raleigh Hospital
Contact: Site Public Contact

Duke Women's Cancer Care Raleigh
Contact: Site Public Contact

ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

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

Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Medical Center Fargo
Contact: Site Public Contact

Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford South University Medical Center
Contact: Site Public Contact

Southpointe-Sanford Medical Center Fargo
Contact: Site Public Contact

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

NE
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

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

NJ
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Contact: Site Public Contact

Hackensack
Hackensack University Medical Center
Contact: Site Public Contact

Middletown
Memorial Sloan Kettering Monmouth
Contact: Site Public Contact

Montvale
Memorial Sloan Kettering Bergen
Contact: Site Public Contact

Neptune
Jersey Shore Medical Center
Contact: Site Public Contact

Red Bank
Riverview Medical Center/Booker Cancer Center
Contact: Site Public Contact

NY
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org

Commack
Memorial Sloan Kettering Commack
Contact: Site Public Contact

Glens Falls
Glens Falls Hospital
Contact: Site Public Contact

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org

Memorial Sloan Kettering Cancer Center
Contact: Site Public Contact

Uniondale
Memorial Sloan Kettering Nassau
Contact: Site Public Contact

West Harrison
Memorial Sloan Kettering Westchester
Contact: Site Public Contact

OH
Avon
UH Seidman Cancer Center at UH Avon Health Center
Contact: Site Public Contact

Beachwood
UHHS-Chagrin Highlands Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

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

Belpre
Strecker Cancer Center-Belpre
Contact: Site Public Contact
Email: sheree@columbusccop.org

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

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

Chillicothe
Adena Regional Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.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

University of Cincinnati Cancer Center-UC Medical Center
Contact: Site Public Contact
Email: cancer@uchealth.com

Cleveland
Case Western Reserve University
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Columbus
Columbus Oncology and Hematology Associates Inc
Contact: Site Public Contact
Email: sheree@columbusccop.org

Doctors Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Grant Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Carmel East Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Carmel Health Center West
Contact: Site Public Contact
Email: sheree@columbusccop.org

Ohio State University Comprehensive Cancer Center
Contact: Site Public Contact
Email: Jamesline@osumc.edu

Riverside Methodist Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

The Mark H Zangmeister Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Dayton
Dayton Blood and Cancer Center
Contact: Site Public Contact

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

Delaware
Delaware Health Center-Grady Cancer Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Grady Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Dublin
Columbus Oncology and Hematology Associates
Contact: Site Public Contact
Email: sheree@columbusccop.org

Dublin Methodist Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.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

Gahanna
Central Ohio Breast and Endocrine Surgery
Contact: Site Public Contact
Email: sheree@columbusccop.org

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

Miami Valley Cancer Care and Infusion
Contact: Site Public Contact

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

Grove City
Mount Carmel Grove City Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Zangmeister Center Grove City
Contact: Site Public Contact
Email: sheree@columbusccop.org

Kettering
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

Lancaster
Fairfield Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Lima
Saint Rita's Medical Center
Contact: Site Public Contact

Mansfield
OhioHealth Mansfield Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marietta
Marietta Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marion
OhioHealth Marion General Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Maumee
Toledo Clinic Cancer Centers-Maumee
Contact: Site Public Contact
Email: pshoup@toledoclinic.com

Mount Vernon
Knox Community Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

New Albany
Mount Carmel New Albany Surgical Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Newark
Licking Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Newark Radiation Oncology
Contact: Site Public Contact
Email: sheree@columbusccop.org

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

Portsmouth
Southern Ohio Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.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

Saint Vincent Mercy Medical Center
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

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

West Chester
University of Cincinnati Cancer Center-West Chester
Contact: Site Public Contact
Email: cancer@uchealth.com

Westerville
Saint Ann's Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

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

Zanesville
Genesis Healthcare System Cancer Care Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

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

University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

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

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

Danville
Geisinger Medical Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

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

Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

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

Hershey
Penn State Milton S Hershey Medical Center
Contact: Site Public Contact
Email: CTO@hmc.psu.edu

Lewisburg
Geisinger Medical Oncology-Lewisburg
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Philadelphia
Thomas Jefferson University Hospital
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu

Pottsville
Geisinger Cancer Services-Pottsville
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Scranton
Community Medical Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Wilkes-Barre
Geisinger Wyoming Valley/Henry Cancer Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

SC
Gaffney
Gibbs Cancer Center-Gaffney
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

Greer
Gibbs Cancer Center-Pelham
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

Spartanburg
North Grove Medical Park
Contact: Site Public Contact

Spartanburg Medical Center
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

Spartanburg Medical Center - Mary Black Campus
Contact: Site Public Contact

Union
MGC Hematology Oncology-Union
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org

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

UT
Salt Lake City
Huntsman Cancer Institute/University of Utah
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

VA
Charlottesville
University of Virginia Cancer Center
Contact: Site Public Contact
Email: uvacancertrials@hscmail.mcc.virginia.edu

VT
Berlin
Central Vermont Medical Center/National Life Cancer Treatment
Contact: Site Public Contact

Burlington
University of Vermont Medical Center
Contact: Site Public Contact
Email: rpo@uvm.edu

University of Vermont and State Agricultural College
Contact: Site Public Contact
Email: rpo@uvm.edu

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

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

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

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

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

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

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

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact

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

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

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

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

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

PRIMARY OBJECTIVE:
I. To determine the 12 month event free survival (EFS) rate following discontinuation of anti-PD-1 therapy in patients with disease control and negative fludeoxyglucose F-18 (FDG)- positron emission tomography (PET)/computed tomography (CT) scan or biopsy for residual disease after 12 months of anti-PD-1 therapy (Arm A).

SECONDARY OBJECTIVES:
I. To determine rates of pathologic response in patients with tumor biopsies where positive hypermetabolic activity was present on FDG-PET/CT scan after 12 months of anti-PD-1 therapy (Arm B).
II. To determine the overall 24 month EFS.
III. To determine overall survival from start of anti-PD-1 therapy.
IV. To determine percentage for patients who remain on treatment beyond 12 months because of positive FDG-PET/CT scan and positive biopsy for residual disease (or unable to obtain a biopsy).
V. To determine incidence rates of treatment-related adverse events beyond 12 months from start of treatment in patients who discontinue anti-PD-1 therapy at 12 months and in patients who continue anti-PD-1 based therapies beyond 12 months (Arm A versus [vs.] Arm B).

EXPLORATORY OBJECTIVES:
I. To assess agreement in determining FDG-PET/CT positivity between the local site read and central review.
II. To determine if metabolic response on serial FDG-PET/CT from pre-therapy to 12 months of anti-PD-1 therapy, as determined centrally by various criteria, is associated with EFS.
III. To determine if metabolic response on serial FDG-PET/CT from 12 to 24 months after start of anti-PD-1 therapy, as determined centrally by various criteria, is associated with EFS.

BIOMARKER OBJECTIVE:
I. To bank tumor samples and peripheral blood for future biomarker studies.

OUTLINE: Patients continue their standard of care anti-PD-1 therapy and are then assigned to 1 of 2 arms.

STANDARD OF CARE: Treatment may consist of the following regimens: 1) nivolumab intravenously (IV) over 30 minutes every 2 weeks (Q2W) or every 4 weeks (Q4W); 2) pembrolizumab IV over 30 minutes every 3 weeks (Q3W) or every 6 weeks (Q6W); 3) nivolumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by nivolumab IV over 30 minutes Q2W or Q4W; or 4) pembrolizumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by pembrolizumab IV over 30 minutes Q3W or Q6W. Treatment continues until 52 weeks from start of standard of care anti-PD-1 therapy in the absence of disease progression or unacceptable toxicity. 

ARM A: Patients with a negative FDG-PET/CT scan or a positive FDG-PET/CT scan but with a negative biopsy for viable tumor discontinue the anti-PD-1 therapy and undergo active surveillance.

ARM B: Patients with a positive FDG-PET/CT scan and positive biopsy for viable tumor or a positive FDG-PET/CT scan and biopsy not performed receive nivolumab IV over 30 minutes Q2W or Q4W, or pembrolizumab IV over 30 minutes Q3W or Q6W for 48 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, and tumor biopsy throughout the study. Patients may optionally undergo blood sample collection throughout the study.

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.


EA6192 / PET-Stop Home Page
ECOG-ACRIN Cancer Research Group