Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
About this trial
This is an interventional treatment trial for Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Eligibility Criteria
Inclusion Criteria:
- 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), Crohn'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, Sjogren'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
Sites / Locations
- Thomas HospitalRecruiting
- Mobile Infirmary Medical CenterRecruiting
- Anchorage Associates in Radiation MedicineRecruiting
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLCRecruiting
- Alaska Oncology and Hematology LLCRecruiting
- Alaska Women's Cancer CareRecruiting
- Anchorage Oncology CentreRecruiting
- Katmai Oncology GroupRecruiting
- Providence Alaska Medical CenterRecruiting
- Fairbanks Memorial HospitalRecruiting
- CTCA at Western Regional Medical Center
- Kingman Regional Medical CenterRecruiting
- Cancer Center at Saint Joseph'sRecruiting
- Mercy Hospital Fort SmithRecruiting
- CHI Saint Vincent Cancer Center Hot Springs
- Kaiser Permanente-Deer Valley Medical Center
- Mission Hope Medical Oncology - Arroyo GrandeRecruiting
- PCR OncologyRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
- Mercy Cancer Center �� CarmichaelRecruiting
- Mercy San Juan Medical CenterRecruiting
- Epic Care-DublinRecruiting
- Kaiser Permanente Dublin
- Mercy Cancer Center - Elk GroveRecruiting
- Bay Area Breast Surgeons IncRecruiting
- Epic Care Partners in Cancer CareRecruiting
- Kaiser Permanente-Fremont
- Fresno Cancer Center
- Kaiser Permanente-Fresno
- UC San Diego Moores Cancer Center
- Tibor Rubin VA Medical Center
- Contra Costa Regional Medical CenterRecruiting
- Kaiser Permanente-Modesto
- Providence Queen of The ValleyRecruiting
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor InstituteRecruiting
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- VA Palo Alto Health Care SystemRecruiting
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Mercy Cancer Center - RocklinRecruiting
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- The Permanente Medical Group-Roseville Radiation Oncology
- Kaiser Permanente Downtown Commons
- Mercy Cancer Center - SacramentoRecruiting
- South Sacramento Cancer Center
- Salinas Valley MemorialRecruiting
- UC San Diego Medical Center - Hillcrest
- Naval Medical Center -San Diego
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Kaiser Permanente-Santa Rosa
- Providence Medical Foundation - Santa RosaRecruiting
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Epic Care Cyberknife CenterRecruiting
- Woodland Memorial HospitalRecruiting
- Rocky Mountain Cancer Centers-AuroraRecruiting
- The Medical Center of Aurora
- UCHealth University of Colorado HospitalRecruiting
- Boulder Community HospitalRecruiting
- Boulder Community Foothills Hospital
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Rocky Mountain Cancer Centers - Centennial
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- UCHealth Memorial Hospital CentralRecruiting
- Memorial Hospital NorthRecruiting
- Saint Francis Cancer CenterRecruiting
- Cancer Center of Colorado at Sloan's Lake
- National Jewish Health-Main Campus
- The Women's Imaging Center
- Porter Adventist HospitalRecruiting
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health OneRecruiting
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western Surgical Care
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - SwedishRecruiting
- Rocky Mountain Cancer Centers - Swedish
- Swedish Medical CenterRecruiting
- The Melanoma and Skin Cancer InstituteRecruiting
- Poudre Valley HospitalRecruiting
- Cancer Care and Hematology-Fort CollinsRecruiting
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- UCHealth Greeley HospitalRecruiting
- Good Samaritan Medical Center
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony HospitalRecruiting
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Littleton Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United HospitalRecruiting
- Rocky Mountain Cancer Centers-Longmont
- Medical Center of the RockiesRecruiting
- McKee Medical Center
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical CenterRecruiting
- National Jewish Health-Northern Hematology Oncology
- Rocky Mountain Cancer Centers-ThorntonRecruiting
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital Care Center at GreenwichRecruiting
- Smilow Cancer Hospital Care Center - GuilfordRecruiting
- Smilow Cancer Center/Yale-New Haven HospitalRecruiting
- Yale UniversityRecruiting
- Yale-New Haven Hospital North Haven Medical CenterRecruiting
- Smilow Cancer Hospital-Orange Care CenterRecruiting
- Smilow Cancer Hospital Care Center-TrumbullRecruiting
- Smilow Cancer Hospital Care Center - WaterfordRecruiting
- Beebe South Coastal Health CampusRecruiting
- Beebe Medical CenterRecruiting
- Delaware Clinical and Laboratory Physicians PARecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Christiana Care Health System-Christiana HospitalRecruiting
- Beebe Health CampusRecruiting
- George Washington University Medical CenterRecruiting
- Broward Health North
- Holy Cross HospitalRecruiting
- Broward Health Medical Center
- The Watson ClinicRecruiting
- Moffitt Cancer Center-International PlazaRecruiting
- Moffitt Cancer Center - McKinley CampusRecruiting
- Moffitt Cancer CenterRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Atlanta VA Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
- South Georgia Medical Center/Pearlman Cancer CenterRecruiting
- Hawaii Cancer Care - WestridgeRecruiting
- Pali Momi Medical CenterRecruiting
- Queen's Cancer Center - PearlridgeRecruiting
- The Cancer Center of Hawaii-Pali MomiRecruiting
- Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
- Queen's Cancer Cenrer - POB IRecruiting
- Queen's Medical CenterRecruiting
- Straub Clinic and HospitalRecruiting
- University of Hawaii Cancer CenterRecruiting
- Kuakini Medical CenterRecruiting
- Queen's Cancer Center - KuakiniRecruiting
- The Cancer Center of Hawaii-LilihaRecruiting
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and ChildrenRecruiting
- Wilcox Memorial Hospital and Kauai Medical ClinicRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Idaho Urologic Institute-MeridianRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Saint Anthony's Health
- Rush - Copley Medical CenterRecruiting
- Advocate Good Shepherd HospitalRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Saint Mary's HospitalRecruiting
- Northwestern UniversityRecruiting
- John H Stroger Jr Hospital of Cook CountyRecruiting
- University of IllinoisRecruiting
- Advocate Illinois Masonic Medical CenterRecruiting
- AMG Crystal Lake - OncologyRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Illinois CancerCare-DixonRecruiting
- Advocate Good Samaritan HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Advocate Sherman HospitalRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Advocate South Suburban HospitalRecruiting
- AMITA Health Cancer Institute and Outpatient Center
- Illinois CancerCare-Kewanee ClinicRecruiting
- Northwestern Medicine Lake Forest Hospital
- AMG Libertyville - OncologyRecruiting
- Condell Memorial HospitalRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Good Samaritan Regional Health CenterRecruiting
- Cancer Care Center of O'FallonRecruiting
- Advocate Christ Medical CenterRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Advocate Lutheran General HospitalRecruiting
- Illinois CancerCare-PekinRecruiting
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment CenterRecruiting
- Illinois CancerCare-PeoriaRecruiting
- OSF Saint Francis Radiation Oncology at Peoria Cancer CenterRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Southwest Illinois Health Services LLP
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare Center
- Parkview Regional Medical CenterRecruiting
- Community Cancer Center EastRecruiting
- Community Cancer Center SouthRecruiting
- Franciscan Health IndianapolisRecruiting
- Community Cancer Center NorthRecruiting
- Community Howard Regional HealthRecruiting
- Woodland Cancer Care Center
- Franciscan Health MooresvilleRecruiting
- Union HospitalRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - Boone
- Saint Anthony Regional Hospital
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Alegent Health Mercy Hospital
- Greater Regional Medical CenterRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical Center
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer Center
- Trinity Regional Medical Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Methodist West Hospital
- Mercy Medical Center-West LakesRecruiting
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph HospitalRecruiting
- Saint Joseph Radiation Oncology Resource CenterRecruiting
- Saint Joseph Hospital EastRecruiting
- Saint Joseph London
- Jewish Hospital
- The James Graham Brown Cancer Center at University of LouisvilleRecruiting
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center NortheastRecruiting
- Jewish Hospital Medical Center South
- LSU Health Baton Rouge-North ClinicRecruiting
- Our Lady of The LakeRecruiting
- Louisiana Hematology Oncology Associates LLCRecruiting
- Mary Bird Perkins Cancer CenterRecruiting
- Our Lady of the Lake Physicians Group - Medical OncologyRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- Greater Baltimore Medical CenterRecruiting
- UM Upper Chesapeake Medical CenterRecruiting
- Tufts Medical CenterRecruiting
- Lowell General HospitalRecruiting
- Mercy Medical Center
- UMass Memorial Medical Center - University CampusRecruiting
- Saint Joseph Mercy HospitalRecruiting
- Bronson Battle CreekRecruiting
- McLaren Cancer Institute-Bay CityRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer CenterRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-Clarkston
- McLaren Cancer Institute-ClarkstonRecruiting
- Newland Medical Associates-Clarkston
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors Park
- Weisberg Cancer Treatment CenterRecruiting
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- McLaren Cancer Institute-FlintRecruiting
- Singh and Arora Hematology Oncology PCRecruiting
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe Woods
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer Center
- Borgess Medical CenterRecruiting
- Karmanos Cancer Institute at McLaren Greater LansingRecruiting
- Mid-Michigan Physicians-LansingRecruiting
- Sparrow HospitalRecruiting
- McLaren Cancer Institute-Lapeer RegionRecruiting
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- McLaren Cancer Institute-MacombRecruiting
- McLaren Cancer Institute-Central MichiganRecruiting
- Trinity Health Muskegon HospitalRecruiting
- Lakeland Hospital NilesRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- McLaren Cancer Institute-Northern MichiganRecruiting
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy OaklandRecruiting
- McLaren-Port HuronRecruiting
- Spectrum Health Reed City HospitalRecruiting
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Lakeland Medical Center Saint JosephRecruiting
- Marie Yeager Cancer CenterRecruiting
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical CenterRecruiting
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- University of Michigan Health - WestRecruiting
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - BurnsvilleRecruiting
- Cambridge Medical Center
- Mercy HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity Hospital
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Minneapolis VA Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- New Ulm Medical Center
- Fairview Northland Medical Center
- North Memorial Medical Health CenterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Sanford Thief River Falls Medical Center
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Sanford Cancer Center Worthington
- Fairview Lakes Medical Center
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - BolivarRecruiting
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Capital Region Southwest CampusRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-South City
- Mercy Hospital SouthRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer CenterRecruiting
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess HospitalRecruiting
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls ClinicRecruiting
- Saint Peter's Community Hospital
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community HospitalRecruiting
- Community Medical HospitalRecruiting
- Nebraska Medicine-BellevueRecruiting
- CHI Health Saint Francis
- CHI Health Good SamaritanRecruiting
- Saint Elizabeth Regional Medical Center
- Nebraska Medicine-Village PointeRecruiting
- Alegent Health Immanuel Medical CenterRecruiting
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Alegent Health Lakeside HospitalRecruiting
- Creighton University Medical CenterRecruiting
- University of Nebraska Medical CenterRecruiting
- Midlands Community Hospital
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven HillsRecruiting
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- Las Vegas Urology - Green Valley
- Las Vegas Urology - Pebble
- Urology Specialists of Nevada - Green Valley
- Las Vegas Urology - Pecos
- Desert West Surgery
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada CentralRecruiting
- Urology Specialists of Nevada - Central
- GenesisCare USA - Las VegasRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical Center
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Las Vegas Prostate Cancer Center
- Las Vegas Urology - Sunset
- Urology Specialists of Nevada - Southwest
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Ann M Wierman MD LTD
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- GenesisCare USA - Vegas Tenaya
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Las Vegas Urology - Cathedral Rock
- Las Vegas Urology - Smoke Ranch
- OptumCare Cancer Care at MountainViewRecruiting
- Urology Specialists of Nevada - Northwest
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of NevadaRecruiting
- GenesisCare USA - Fort ApacheRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Radiation Oncology AssociatesRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- AtlantiCare Health Park-Cape May Court HouseRecruiting
- AtlantiCare Surgery CenterRecruiting
- Jersey City Medical CenterRecruiting
- Saint Barnabas Medical CenterRecruiting
- Virtua Samson Cancer Center
- Morristown Medical CenterRecruiting
- Virtua Memorial
- Rutgers Cancer Institute of New JerseyRecruiting
- Rutgers New Jersey Medical SchoolRecruiting
- Overlook HospitalRecruiting
- Virtua Voorhees
- University of New Mexico Cancer CenterRecruiting
- Montefiore Medical Center-Einstein CampusRecruiting
- Montefiore Medical Center-Weiler HospitalRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Roswell Park Cancer InstituteRecruiting
- University of RochesterRecruiting
- Stony Brook University Medical CenterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- SUNY Upstate Medical Center-Community CampusRecruiting
- AdventHealth Infusion Center Asheville
- Novant Health Presbyterian Medical CenterRecruiting
- AdventHealth Infusion Center Haywood
- CaroMont Regional Medical CenterRecruiting
- East Carolina UniversityRecruiting
- AdventHealth Hendersonville
- Novant Health Cancer Institute - HuntersvilleRecruiting
- Novant Health Presbyterian Medical Center HuntersvilleRecruiting
- Novant Health Cancer Institute - KernersvilleRecruiting
- Novant Health Cancer Institute - MatthewsRecruiting
- Novant Health Cancer Institute - MooresvilleRecruiting
- Novant Health Cancer Institute - Mount AiryRecruiting
- CarolinaEast Medical CenterRecruiting
- Novant Health Cancer Institute - StatesvilleRecruiting
- Novant Health Cancer Institute - ThomasvilleRecruiting
- AdventHealth Infusion Center Weaverville
- Novant Health Cancer Institute - WilkesboroRecruiting
- Novant Health Forsyth Medical CenterRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford South University Medical Center
- Southpointe-Sanford Medical Center Fargo
- Sanford Medical Center Fargo
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Summa Health System - Akron CampusRecruiting
- UH Seidman Cancer Center at UH Avon Health CenterRecruiting
- Summa Health System - Barberton CampusRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Cleveland Clinic Mercy HospitalRecruiting
- Mercy Hematology and Oncology Associates Inc
- Miami Valley Hospital SouthRecruiting
- Geauga HospitalRecruiting
- Good Samaritan Hospital - CincinnatiRecruiting
- Bethesda North HospitalRecruiting
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve UniversityRecruiting
- MetroHealth Medical CenterRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Dayton Blood and Cancer CenterRecruiting
- Miami Valley HospitalRecruiting
- Miami Valley Hospital NorthRecruiting
- Mercy Cancer Center-Elyria
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- Miami Valley Cancer Care and InfusionRecruiting
- Cleveland Clinic Cancer Center MansfieldRecruiting
- Hillcrest Hospital Cancer CenterRecruiting
- Summa Health Medina Medical CenterRecruiting
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- UH Seidman Cancer Center at Southwest General HospitalRecruiting
- University Hospitals Parma Medical CenterRecruiting
- University Hospitals Portage Medical CenterRecruiting
- North Coast Cancer CareRecruiting
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- Upper Valley Medical CenterRecruiting
- UH Seidman Cancer Center at Saint John Medical CenterRecruiting
- UHHS-Westlake Medical CenterRecruiting
- Cancer Centers of Southwest Oklahoma ResearchRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health SystemRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area HospitalRecruiting
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-Ontario
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Christiana Care Health System-Concord Health CenterRecruiting
- Geisinger Medical CenterRecruiting
- Pocono Medical CenterRecruiting
- UPMC Hillman Cancer Center ErieRecruiting
- UPMC Cancer Center at UPMC HorizonRecruiting
- Lehigh Valley Hospital-Hazleton
- Penn State Milton S Hershey Medical CenterRecruiting
- Geisinger Medical Oncology-LewisburgRecruiting
- Lewistown HospitalRecruiting
- Thomas Jefferson University HospitalRecruiting
- Jefferson Torresdale HospitalRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- UPMC-Shadyside HospitalRecruiting
- Geisinger Cancer Services-PottsvilleRecruiting
- Reading HospitalRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Asplundh Cancer PavilionRecruiting
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South CarolinaRecruiting
- Prisma Health Cancer Institute - Easley
- Gibbs Cancer Center-Gaffney
- Saint Francis HospitalRecruiting
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - FarisRecruiting
- Saint Francis Cancer CenterRecruiting
- Prisma Health Cancer Institute - EastsideRecruiting
- Prisma Health Cancer Institute - GreerRecruiting
- Gibbs Cancer Center-Pelham
- Prisma Health Cancer Institute - SenecaRecruiting
- Spartanburg Medical Center
- MGC Hematology Oncology-Union
- Avera Cancer Institute-AberdeenRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer InstituteRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- The Don and Sybil Harrington Cancer CenterRecruiting
- Dell Seton Medical Center at The University of Texas
- Saint Joseph Regional Cancer Center
- Parkland Memorial HospitalRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- Memorial Hermann Texas Medical CenterRecruiting
- Memorial Hermann Northeast HospitalRecruiting
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Riverton Hospital
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- Norris Cotton Cancer Center-NorthRecruiting
- VCU Massey Cancer Center at Stony PointRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Providence Regional Cancer System-AberdeenRecruiting
- MultiCare Auburn Medical Center
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical CenterRecruiting
- Harrison HealthPartners Hematology and Oncology-BremertonRecruiting
- Harrison Medical CenterRecruiting
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-CentraliaRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- Saint Elizabeth Hospital
- Providence Regional Cancer PartnershipRecruiting
- Saint Francis Hospital
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-IssaquahRecruiting
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-LaceyRecruiting
- Saint Clare Hospital
- PeaceHealth Saint John Medical CenterRecruiting
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Valley Medical CenterRecruiting
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard CampusRecruiting
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First HillRecruiting
- PeaceHealth United General Medical CenterRecruiting
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Franciscan Research Center-Northwest Medical Plaza
- Mary Bridge Children's Hospital and Health Center
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical CenterRecruiting
- Providence Saint Mary Regional Cancer CenterRecruiting
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
- Providence Regional Cancer System-Yelm
- ThedaCare Regional Cancer CenterRecruiting
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- HSHS Sacred Heart HospitalRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- Aurora BayCare Medical CenterRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- Holy Family Memorial Hospital
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Froedtert Menomonee Falls HospitalRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Medical College of WisconsinRecruiting
- Aurora Sinai Medical CenterRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Drexel Town Square Health CenterRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Saint Vincent Hospital Cancer Center at Oconto FallsRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Aurora Cancer Care-RacineRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- HSHS Saint Nicholas HospitalRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
- Aurora Medical Center in SummitRecruiting
- Vince Lombardi Cancer Clinic-Two RiversRecruiting
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth CareRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Diagnostic and Treatment CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
- Welch Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Arm A (cisplatin, IMRT, nivolumab)
Arm B (cisplatin, IMRT, observation)
Arm C (nivolumab)
Patients receive cisplatin IV over 60 minutes weekly and 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. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.
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. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.
Patients receive nivolumab IV over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.