Throat Cancer

EA3161



Testing Immunotherapy versus Observation in Patients with HPV Throat Cancer

STATUS: Active


This phase III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer (throat cancer) that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin 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. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. 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. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.
  • STEP 1: Age >= 18 years

  • STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • STEP 1: Patients must have oropharynx cancer (American Joint Committee on Cancer [AJCC] 8) that is p16-positive by immunohistochemistry OR p16 equivocal by IHC and HPV positive by in situ hybridization with the following criteria: >= 10 pack-years, stage T1-2N2-N3 or T3-4N0-3 (less than 10 pack-years is considered a non-smoker) OR < 10 pack-years, stage T4N0-N3 or T1-3N2-3

  • STEP 1: Patients must not have known hypersensitivity to nivolumab or compounds of similar chemical or biologic composition.

  • STEP 1: Patients with a history of allergic reactions attributed to platinum-based chemotherapy agents are excluded.

  • STEP 1: Patients must not have had prior systemic therapy, radiation treatment or surgery for p16 positive oropharyngeal squamous cell carcinoma (OPSCC). * NOTE: Patients who had resection of T1 or T2 carcinoma with no radiation or chemotherapy are eligible if surgery was done 5 years prior to enrollment

  • STEP 1: Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors.

  • STEP 1: Patients must not receive investigational agents within 4 weeks of enrollment or at any time while on study.

  • STEP 1: Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded.

  • STEP 1: Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded.

  • STEP 1: Patients with a history of prior or second malignancy are excluded, with the exception of curatively treated non-melanoma skin cancer, or curatively treated cervical cancer; additionally, patients curatively treated for malignancy who remain disease-free at > 2 years of follow up, are not excluded.

  • STEP 1: Absolute neutrophil count (ANC) >= 1500/mm^3 (must be obtained =< 2 weeks prior to randomization).

  • STEP 1: Hemoglobin (Hgb) >= 8.0 g/dL (must be obtained =< 2 weeks prior to randomization).

  • STEP 1: Platelet count >= 100,000/mm^3 (must be obtained =< 2 weeks prior to randomization).

  • STEP 1: Creatinine clearance of >= 60 ml/min (must be obtained =< 2 weeks prior to randomization). Creatinine clearance may be measured or calculated. If calculating, creatinine clearance, use the Cockcroft-Gault formula.

  • STEP 1: Total bilirubin within 1.5 times the normal limits (must be obtained =< 2 weeks prior to randomization).

  • STEP 1: Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) within 2.0 times the normal limits (must be obtained =< 2 weeks prior to randomization).

  • STEP 1: Alkaline phosphatase within 2.0 times the normal limits (must be obtained =< 2 weeks prior to randomization).

  • STEP 1: Patients must not be pregnant or breast-feeding as chemotherapy, radiation, and immunotherapy may have possible teratogenicity effects; in addition, complications from pregnancy may interfere with the ability of patients to have an uninterrupted therapy. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy. A patient of childbearing potential is any female, 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).

  • STEP 1: Patients of childbearing potential must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment. Patients must also not donate ova during this same time period.

  • STEP 1: Patients must have measurable disease

  • STEP 1: Patients must have tumor measurements with CT of neck and CT of chest (or CT of neck and FDG PET/CT if standard of care) within 4 weeks prior to Step 1 randomization.

  • STEP 1: Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohnโ€™s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogrenโ€™s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.

  • STEP 1: Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).

  • STEP 1: Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications which are expected to continue during nivolumab administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease

  • STEP 1: Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • STEP 1: 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

  • STEP 1: Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable antiviral regimen

  • STEP 1: Patients must not be receiving any other investigational agents.

  • STEP 1: Patient must not have a baseline clinically significant hearing loss, which in the opinion of the investigator would preclude the use of cisplatin

  • STEP 2: Patients must have progression per RECIST criteria AND tissue-proven progression on Arm B treatment within 12 months after completion of radiation therapy.

  • STEP 2: ECOG performance status of 0 or 1.

  • STEP 2: Patients must not have known hypersensitivity to nivolumab or compounds of similar chemical or biologic composition.

  • STEP 2: Patients must not have received non-protocol anti-cancer therapy after completion of radiation and chemotherapy.

  • STEP 2: ANC >= 1500/mm^3 (must be obtained =< 2 weeks prior to registration).

  • STEP 2: Hgb >= 8.0 g/dL (must be obtained =< 2 weeks prior to registration).

  • STEP 2: Platelet count >= 100,000/mm^3 (must be obtained =< 2 weeks prior to registration).

  • STEP 2: Creatinine within institutional limits of normal (must be obtained =< 2 weeks prior to registration)

  • STEP 2: Total bilirubin within 1.5 times the normal limits (must be obtained =< 2 weeks prior to registration).

  • STEP 2: SGOT (AST) or SGPT (ALT) within 2.0 times the normal limits (must be obtained =< 2 weeks prior to registration).

  • STEP 2: Alkaline phosphatase within 1.5 times the normal limits (must be obtained =< 2 weeks prior to registration).

  • STEP 2: Patients must not be pregnant or breast-feeding as chemotherapy, radiation, and immunotherapy may have possible teratogenicity effects; in addition, complications from pregnancy may interfere with the ability of patients to have an uninterrupted therapy. All women of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A women of childbearing potential is any female, 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).

  • STEP 2: Patients of childbearing potential must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment. Patients must also not donate ova during this same time period.

  • STEP 2: Patients must have measurable disease at the time of documented progression * NOTE: For patients that have undergone salvage surgery for disease recurrence, measurable disease is not required at the time of registration to Step 2

  • STEP 2: Patients must have tumor measurements with CT of neck and CT of chest (or CT of neck and FDG PET/CT if standard of care) within 4 weeks prior to Step 2 registration * NOTE: Patients that have undergone salvage surgery for disease recurrence prior to Step 2 are not required to have measurable disease post-resection, but must have CT of neck and CT of chest (or CT of neck and FDG PET/CT if standard of care) after salvage surgery and within 4 weeks prior to step 2 registration to establish a baseline prior to nivolumab

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
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Alaska Oncology and Hematology LLC
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Katmai Oncology Group
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Providence Alaska Medical Center
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Fairbanks Memorial Hospital
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AL
Fairhope
Thomas Hospital
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Mobile Infirmary Medical Center
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AR
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Mercy Hospital Fort Smith
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AZ
Goodyear
CTCA at Western Regional Medical Center
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Kingman
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Cancer Center at Saint Joseph's
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CA
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Mission Hope Medical Oncology - Arroyo Grande
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PCR Oncology
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Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Carmichael
Mercy Cancer Center ๏ฟฝ๏ฟฝ Carmichael
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Mercy San Juan Medical Center
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Dublin
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Kaiser Permanente Dublin
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Elk Grove
Mercy Cancer Center - Elk Grove
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Emeryville
Bay Area Breast Surgeons Inc
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Epic Care Partners in Cancer Care
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La Jolla
UC San Diego Moores Cancer Center
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Tibor Rubin VA Medical Center
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Contra Costa Regional Medical Center
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Modesto
Kaiser Permanente-Modesto
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Providence Queen of The Valley
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Oakland
Alta Bates Summit Medical Center - Summit Campus
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Bay Area Tumor Institute
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VA Palo Alto Health Care System
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Richmond
Kaiser Permanente-Richmond
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Rocklin
Mercy Cancer Center - Rocklin
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Rohnert Park Cancer Center
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Roseville
Kaiser Permanente-Roseville
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The Permanente Medical Group-Roseville Radiation Oncology
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Sacramento
Kaiser Permanente Downtown Commons
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Mercy Cancer Center - Sacramento
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South Sacramento Cancer Center
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Salinas
Salinas Valley Memorial
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San Diego
Naval Medical Center -San Diego
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San Francisco
Kaiser Permanente-San Francisco
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Kaiser Permanente-Santa Teresa-San Jose
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San Leandro
Kaiser Permanente San Leandro
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San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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San Rafael
Kaiser San Rafael-Gallinas
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Santa Clara
Kaiser Permanente Medical Center - Santa Clara
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Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Santa Rosa
Kaiser Permanente-Santa Rosa
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Providence Medical Foundation - Santa Rosa
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South San Francisco
Kaiser Permanente Cancer Treatment Center
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Kaiser Permanente-South San Francisco
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Stockton
Kaiser Permanente-Stockton
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Vacaville
Kaiser Permanente Medical Center-Vacaville
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Vallejo
Kaiser Permanente-Vallejo
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Walnut Creek
Epic Care Cyberknife Center
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Kaiser Permanente-Walnut Creek
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Woodland
Woodland Memorial Hospital
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CO
Aurora
Rocky Mountain Cancer Centers-Aurora
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The Medical Center of Aurora
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UCHealth University of Colorado Hospital
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Boulder
Boulder Community Foothills Hospital
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Boulder Community Hospital
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Centennial
Rocky Mountain Cancer Centers - Centennial
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Colorado Springs
Memorial Hospital North
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Penrose-Saint Francis Healthcare
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Saint Francis Cancer Center
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UCHealth Memorial Hospital Central
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Denver
Cancer Center of Colorado at Sloan's Lake
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Colorado Blood Cancer Institute
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National Jewish Health-Main Campus
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Porter Adventist Hospital
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Presbyterian - Saint Lukes Medical Center - Health One
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Rocky Mountain Cancer Centers-Midtown
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Rocky Mountain Cancer Centers-Rose
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Rose Medical Center
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SCL Health Saint Joseph Hospital
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The Women's Imaging Center
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Western Surgical Care
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Durango
Mercy Medical Center
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Southwest Oncology PC
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Englewood
Mountain Blue Cancer Care Center - Swedish
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Rocky Mountain Cancer Centers - Swedish
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Swedish Medical Center
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The Melanoma and Skin Cancer Institute
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Fort Collins
Cancer Care and Hematology-Fort Collins
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Poudre Valley Hospital
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Golden
National Jewish Health-Western Hematology Oncology
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Grand Junction
Saint Mary's Hospital and Regional Medical Center
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North Colorado Medical Center
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Lafayette
Good Samaritan Medical Center
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Lakewood
Rocky Mountain Cancer Centers-Lakewood
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Saint Anthony Hospital
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Littleton
Littleton Adventist Hospital
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Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
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Sky Ridge Medical Center
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Longmont
Longmont United Hospital
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Rocky Mountain Cancer Centers-Longmont
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Loveland
McKee Medical Center
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Medical Center of the Rockies
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Parker
Parker Adventist Hospital
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Pueblo
Saint Mary Corwin Medical Center
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Thornton
National Jewish Health-Northern Hematology Oncology
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Rocky Mountain Cancer Centers-Thornton
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Wheat Ridge
SCL Health Lutheran Medical Center
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CT
Greenwich
Smilow Cancer Hospital Care Center at Greenwich
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Guilford
Smilow Cancer Hospital Care Center - Guilford
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New Haven
Smilow Cancer Center/Yale-New Haven Hospital
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Yale University
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North Haven
Yale-New Haven Hospital North Haven Medical Center
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Orange
Smilow Cancer Hospital-Orange Care Center
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Trumbull
Smilow Cancer Hospital Care Center-Trumbull
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Waterford
Smilow Cancer Hospital Care Center - Waterford
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DC
Washington
George Washington University Medical Center
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DE
Frankford
Beebe South Coastal Health Campus
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Lewes
Beebe Medical Center
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Newark
Christiana Care Health System-Christiana Hospital
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Delaware Clinical and Laboratory Physicians PA
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Helen F Graham Cancer Center
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Medical Oncology Hematology Consultants PA
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Rehoboth Beach
Beebe Health Campus
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FL
Deerfield Beach
Broward Health North
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Fort Lauderdale
Broward Health Medical Center
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Holy Cross Hospital
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Lakeland
The Watson Clinic
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Tampa
Moffitt Cancer Center
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Moffitt Cancer Center - McKinley Campus
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Moffitt Cancer Center-International Plaza
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GA
Atlanta
Emory University Hospital Midtown
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Emory University Hospital/Winship Cancer Institute
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Decatur
Atlanta VA Medical Center
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Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Valdosta
South Georgia Medical Center/Pearlman Cancer Center
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HI
Aiea
Hawaii Cancer Care - Westridge
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Pali Momi Medical Center
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Queen's Cancer Center - Pearlridge
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The Cancer Center of Hawaii-Pali Momi
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Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
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Kaiser Permanente Moanalua Medical Center
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Kapiolani Medical Center for Women and Children
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Kuakini Medical Center
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Queen's Cancer Cenrer - POB I
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Queen's Cancer Center - Kuakini
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Queen's Medical Center
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Straub Clinic and Hospital
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The Cancer Center of Hawaii-Liliha
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University of Hawaii Cancer Center
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Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
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IA
Ames
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Boone
McFarland Clinic - Boone
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Carroll
Saint Anthony Regional Hospital
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Email: sbenson@iora.org

Clive
Medical Oncology and Hematology Associates-West Des Moines
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Mercy Cancer Center-West Lakes
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Council Bluffs
Alegent Health Mercy Hospital
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Creston
Greater Regional Medical Center
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Des Moines
Broadlawns Medical Center
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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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Mission Cancer and Blood - Laurel
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Fort Dodge
McFarland Clinic - Trinity Cancer Center
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Trinity Regional Medical Center
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Jefferson
McFarland Clinic - Jefferson
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Marshalltown
McFarland Clinic - Marshalltown
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West Des Moines
Mercy Medical Center-West Lakes
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Methodist West Hospital
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ID
Boise
Saint Alphonsus Cancer Care Center-Boise
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Email: stephanie.couch@stjoeshealth.org

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

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

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

Emmett
Walter Knox Memorial Hospital
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Fruitland
Saint Luke's Cancer Institute - Fruitland
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Email: eslinget@slhs.org

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

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

Nampa
Saint Alphonsus Cancer Care Center-Nampa
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Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
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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

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

Chicago
Advocate Illinois Masonic Medical Center
Contact: Site Public Contact

John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact

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

University of Illinois
Contact: Site Public Contact

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

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

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

Hinsdale
AMITA Health Cancer Institute and Outpatient 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

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

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
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

OSF Saint Francis Medical Center
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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
Fort Wayne
Parkview Regional Medical Center
Contact: Site Public Contact

Indianapolis
Community Cancer Center East
Contact: Site Public Contact
Email: lcheri@ecommunity.com

Community Cancer Center North
Contact: Site Public Contact
Email: lcheri@ecommunity.com

Community Cancer Center South
Contact: Site Public Contact
Email: lcheri@ecommunity.com

Franciscan Health Indianapolis
Contact: Site Public Contact

Kokomo
Community Howard Regional Health
Contact: Site Public Contact
Email: oncology@communityhoward.org

Michigan City
Woodland Cancer Care Center
Contact: Site Public Contact
Email: sally.arnett@franciscanalliance.org

Mooresville
Franciscan Health Mooresville
Contact: Site Public Contact

Terre Haute
Union Hospital
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

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

The James Graham Brown Cancer Center at University of Louisville
Contact: Site Public Contact

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

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

MA
Boston
Tufts Medical Center
Contact: Site Public Contact
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Lowell
Lowell General Hospital
Contact: Site Public Contact
Email: ghincks@lowellgeneral.org

Springfield
Mercy Medical Center
Contact: Site Public Contact

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

MD
Baltimore
Greater Baltimore Medical Center
Contact: Site Public Contact

University of Maryland/Greenebaum Cancer Center
Contact: Site Public Contact

Bel Air
UM Upper Chesapeake Medical Center
Contact: Site Public Contact

MI
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

Bay City
McLaren Cancer Institute-Bay City
Contact: Site Public Contact
Email: ctoadmin@karmanos.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

McLaren Cancer Institute-Clarkston
Contact: Site Public Contact
Email: ctoadmin@karmanos.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

Wayne State University/Karmanos Cancer Institute
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

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

Farmington Hills
Weisberg Cancer Treatment Center
Contact: Site Public Contact
Email: ctoadmin@karmanos.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

McLaren Cancer Institute-Flint
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Singh and Arora Hematology Oncology PC
Contact: Site Public Contact
Email: ctoadmin@karmanos.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
Karmanos Cancer Institute at McLaren Greater Lansing
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Mid-Michigan Physicians-Lansing
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Sparrow Hospital
Contact: Site Public Contact

Lapeer
McLaren Cancer Institute-Lapeer Region
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

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

Mount Clemens
McLaren Cancer Institute-Macomb
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Mount Pleasant
McLaren Cancer Institute-Central Michigan
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

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

Petoskey
McLaren Cancer Institute-Northern Michigan
Contact: Site Public Contact
Email: ctoadmin@karmanos.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

Port Huron
McLaren-Port Huron
Contact: Site Public Contact
Email: ctoadmin@karmanos.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
Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.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

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

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

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

Minneapolis VA Medical Center
Contact: Site Public Contact

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

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

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

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

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

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

Worthington
Sanford Cancer Center Worthington
Contact: Site Public Contact

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

Bonne Terre
Parkland Health Center-Bonne Terre
Contact: Site Public Contact

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

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

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

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

Butte
Saint James Community Hospital and Cancer Treatment Center
Contact: Site Public Contact

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

Helena
Saint Peter's Community Hospital
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
Asheville
AdventHealth Infusion Center Asheville
Contact: Site Public Contact
Email: AMBER.WHEELER@AdventHealth.com

Charlotte
Novant Health Presbyterian Medical Center
Contact: Site Public Contact
Email: kashah@novanthealth.org

Clyde
AdventHealth Infusion Center Haywood
Contact: Site Public Contact
Email: AMBER.WHEELER@AdventHealth.com

Gastonia
CaroMont Regional Medical Center
Contact: Site Public Contact
Email: tammy.cozad@caromonthealth.org

Greenville
East Carolina University
Contact: Site Public Contact
Email: eubankss@ecu.edu

Hendersonville
AdventHealth Hendersonville
Contact: Site Public Contact
Email: AMBER.WHEELER@AdventHealth.com

Huntersville
Novant Health Cancer Institute - Huntersville
Contact: Site Public Contact
Email: kashah@novanthealth.org

Novant Health Presbyterian Medical Center Huntersville
Contact: Site Public Contact
Email: kashah@novanthealth.org

Kernersville
Novant Health Cancer Institute - Kernersville
Contact: Site Public Contact
Email: asmarrs@novanthealth.org

Matthews
Novant Health Cancer Institute - Matthews
Contact: Site Public Contact
Email: kashah@novanthealth.org

Mooresville
Novant Health Cancer Institute - Mooresville
Contact: Site Public Contact
Email: kashah@novanthealth.org

Mount Airy
Novant Health Cancer Institute - Mount Airy
Contact: Site Public Contact
Email: asmarrs@novanthealth.org

New Bern
CarolinaEast Medical Center
Contact: Site Public Contact
Email: lharrison@carolinaeasthealth.com

Stateville
Novant Health Cancer Institute - Statesville
Contact: Site Public Contact
Email: asmarrs@novanthealth.org

Thomasville
Novant Health Cancer Institute - Thomasville
Contact: Site Public Contact
Email: asmarrs@novanthealth.org

Weaverville
AdventHealth Infusion Center Weaverville
Contact: Site Public Contact
Email: AMBER.WHEELER@AdventHealth.com

Wilkesboro
Novant Health Cancer Institute - Wilkesboro
Contact: Site Public Contact
Email: asmarrs@novanthealth.org

Winston-Salem
Novant Health Forsyth Medical Center
Contact: Site Public Contact
Email: asmarrs@novanthealth.org

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

Fargo
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

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

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
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Contact: Site Public Contact
Email: cancer.research.nurse@dartmouth.edu

NJ
Cape May Court House
AtlantiCare Health Park-Cape May Court House
Contact: Site Public Contact

Egg Harbor Township
AtlantiCare Surgery Center
Contact: Site Public Contact

Jersey City
Jersey City Medical Center
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Livingston
Saint Barnabas Medical Center
Contact: Site Public Contact
Email: joanne.loeb@rwjbh.org

Moorestown
Virtua Samson Cancer Center
Contact: Site Public Contact

Morristown
Morristown Medical Center
Contact: Site Public Contact

Mount Holly
Virtua Memorial
Contact: Site Public Contact

New Brunswick
Rutgers Cancer Institute of New Jersey
Contact: Site Public Contact

Newark
Rutgers New Jersey Medical School
Contact: Site Public Contact

Summit
Overlook Hospital
Contact: Site Public Contact

Voorhees
Virtua Voorhees
Contact: Site Public Contact

NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: HSC-ClinicalTrialInfo@salud.unm.edu

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

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

Rochester
University of Rochester
Contact: Site Public Contact

Stony Brook
Stony Brook University Medical Center
Contact: Site Public Contact

Syracuse
SUNY Upstate Medical Center-Community Campus
Contact: Site Public Contact

State University of New York Upstate Medical University
Contact: Site Public Contact

OH
Akron
Summa Health System - Akron Campus
Contact: Site Public Contact
Email: cancerresearch@summahealth.org

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

Barberton
Summa Health System - Barberton Campus
Contact: Site Public Contact
Email: cancerresearch@summahealth.org

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

Canton
Cleveland Clinic Mercy Hospital
Contact: Site Public Contact

Mercy Hematology and Oncology Associates Inc
Contact: Site Public Contact

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

Chardon
Geauga Hospital
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.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

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

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

MetroHealth Medical Center
Contact: Site Public Contact
Email: dstrater@metrohealth.org

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

Dayton
Dayton Blood and Cancer Center
Contact: Site Public Contact

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

Elyria
Mercy Cancer Center-Elyria
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

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

Greenville
Miami Valley Cancer Care and Infusion
Contact: Site Public Contact

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

Medina
Summa Health Medina Medical Center
Contact: Site Public Contact
Email: cancerresearch@summahealth.org

Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Parma
University Hospitals Parma Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Ravenna
University Hospitals Portage Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

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

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

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

Westlake
UH Seidman Cancer Center at Saint John Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

UHHS-Westlake Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

OK
Lawton
Cancer Centers of Southwest Oklahoma Research
Contact: Site Public Contact

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

Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
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

Oregon City
Providence Willamette Falls Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Portland
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

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

Chadds Ford
Christiana Care Health System-Concord Health Center
Contact: Site Public Contact
Email: lbarone@christianacare.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

Erie
UPMC Hillman Cancer Center Erie
Contact: Site Public Contact
Email: haneydl@upmc.edu

Farrell
UPMC Cancer Center at UPMC Horizon
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

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

Lewistown
Lewistown Hospital
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

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

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

Pittsburgh
UPMC-Shadyside Hospital
Contact: Site Public Contact

University of Pittsburgh Cancer Institute (UPCI)
Contact: Site Public Contact

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

West Reading
Reading Hospital
Contact: Site Public Contact

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

Willow Grove
Asplundh Cancer Pavilion
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu

SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Contact: Site Public Contact

Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

Easley
Prisma Health Cancer Institute - Easley
Contact: Site Public Contact
Email: Kim.Williams3@prismahealth.org

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

Greenville
Prisma Health Cancer Institute - Butternut
Contact: Site Public Contact

Prisma Health Cancer Institute - Eastside
Contact: Site Public Contact

Prisma Health Cancer Institute - Faris
Contact: Site Public Contact

Saint Francis Cancer Center
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Saint Francis Hospital
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

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

Prisma Health Cancer Institute - Greer
Contact: Site Public Contact

Seneca
Prisma Health Cancer Institute - Seneca
Contact: Site Public Contact

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

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

SD
Aberdeen
Avera Cancer Institute-Aberdeen
Contact: Site Public Contact
Email: oncregulatory@avera.org

Sioux Falls
Avera Cancer Institute
Contact: Site Public Contact
Email: OncRegulatory@avera.org

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

TN
Nashville
Vanderbilt University/Ingram Cancer Center
Contact: Site Public Contact

TX
Amarillo
The Don and Sybil Harrington Cancer Center
Contact: Site Public Contact
Email: Gina.Cravey@bsahs.org

Austin
Dell Seton Medical Center at The University of Texas
Contact: Site Public Contact

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

Dallas
Parkland Memorial Hospital
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Houston
Memorial Hermann Texas Medical Center
Contact: Site Public Contact

Humble
Memorial Hermann Northeast Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

UT
American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Cedar City
Sandra L Maxwell Cancer Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Logan
Logan Regional Hospital
Contact: Site Public Contact
Email: officeofresearch@imail.org

Murray
Intermountain Medical Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Ogden
McKay-Dee Hospital Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Provo
Utah Valley Regional Medical Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Riverton
Riverton Hospital
Contact: Site Public Contact
Email: officeofresearch@imail.org

Saint George
Saint George Regional Medical Center
Contact: Site Public Contact
Email: officeofresearch@imail.org

Salt Lake City
LDS Hospital
Contact: Site Public Contact
Email: officeofresearch@imail.org

Utah Cancer Specialists-Salt Lake City
Contact: Site Public Contact
Email: officeofresearch@imail.org

VA
Richmond
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

VT
Saint Johnsbury
Norris Cotton Cancer Center-North
Contact: Site Public Contact
Email: cancer.research.nurse@hitchcock.org

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

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

Eau Claire
HSHS Sacred Heart Hospital
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

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

Saint Vincent Hospital Cancer Center Green Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Contact: Site Public Contact
Email: ewd_research_admin@hshs.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

Manitowoc
Holy Family Memorial Hospital
Contact: Site Public Contact

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

Menomonee Falls
Froedtert Menomonee Falls Hospital
Contact: Site Public Contact

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

Medical College of Wisconsin
Contact: Site Public Contact

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

Oak Creek
Drexel Town Square Health Center
Contact: Site Public Contact

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact

Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

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
HSHS Saint Nicholas Hospital
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

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

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

Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

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

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

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

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

West Bend
Froedtert West Bend Hospital/Kraemer Cancer Center
Contact: Site Public Contact

Weston
Diagnostic and Treatment Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center - Weston
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

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 assess the efficacy of concurrent definitive therapy followed by nivolumab compared with concurrent definitive therapy followed by observation in terms of overall survival (OS).

SECONDARY OBJECTIVES:
I. To further assess the efficacy of nivolumab compared with observation in terms of:
Ia. To evaluate treatment effect within the subset of patients tested as PD-L1+ . 
Ib. To evaluate the prognostic effect of baseline saliva and/or plasma HPV status .
Ic. To evaluate the prognostic effect of mutation burden among patients on the nivolumab arm.
Id. To evaluate the association of 12-week post therapy fludeoxyglucose F-18 (FDG) positron emission tomography(PET)/computed tomography (CT) OS and progression free survival (PFS).
Ie. To establish the prognostic value of standardized uptake value (SUV) max of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS (and/or PFS).
If. To correlate SUV max of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive versus [vs.] negative).
Ig. To compare the PET based therapy response assessment (Hopkins criteria) to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessment at 12 week post chemoradiation therapy, for patients who have a PET/CT scan at 12 weeks.
II. To assess the efficacy of concurrent definitive therapy followed by nivolumab in terms of progression free survival (PFS).

OUTLINE: Patients are randomized to Arm A or Arm B. Patients in Arm B may cross-over to Arm C with clearly documented disease progression.

ARM A: Patients receive cisplatin intravenously (IV) over 60 minutes weekly and intensity modulated radiation therapy (IMRT) 5 days a week for 7 weeks for a total of 35 fractions. Within 4 weeks after completion of concurrent therapy, patients receive nivolumab IV once weekly over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions, and then go on observation. Patients will be offered the option to cross-over to Arm C if they have clearly documented progression within 12 months from the end of cisplatin/radiation therapy.

ARM C: Patients receive nivolumab IV over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.

All patients undergo computed tomography (CT) or Fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/CT scans throughout the trial. Patients may undergo echocardiography (ECHO) as clinically indicated. Additionally, patients undergo blood sample collection during screening. 

After completion of study treatment, patients are followed up every 3-6 months for 3 years and then annually for a total of 10 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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ECOG-ACRIN Cancer Research Group