De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
Basaloid Squamous Cell Carcinoma, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
About this trial
This is an interventional treatment trial for Basaloid Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma but not neuroendocrine phenotype) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage)
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Simple tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving =< 4 nodes are permitted and considered as non-therapeutic nodal excisions
P16-positive based on local site immunohistochemical tissue staining (defined as greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining of tumor cells). Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification
- Note: Institutions must screen patients, whose tumors must be p16-positive by immunohistochemistry (IHC) in order to be eligible for the trial using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the United States (U.S.) CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable. The p16-positive results must be reported on the pathology report being submitted
Clinical stage T1-2, N1, M0 (American Joint Committee on Cancer [AJCC], 8th edition [ed.]) or T3, N0-N1, M0 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:
- General history and physical examination within 56 days prior to registration;
- Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable) within 70 days prior to registration;
One of the following imaging studies is required within 56 days prior to registration:
- FDG-PET/CT of the neck and chest (with or without contrast); FDG-PET/CT scan is strongly preferred and highly recommended to be used for eligibility OR
- Chest CT (with or without contrast)
One of the following imaging studies is required within 28 days prior to registration:
- A diagnostic CT scan of neck (with contrast and of diagnostic quality) OR
- An magnetic resonance imaging (MRI) of the neck (with contrast and of diagnostic quality)
- Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck performed for the purposes of radiation planning may serve as both staging and planning tools
Patients must provide their personal smoking history prior to registration. The lifetime cumulative history cannot exceed 10 pack-years. The following formula is used to calculate the pack-years during the periods of smoking in the patient's life; the cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history
- Number of pack-years = [Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)] / 20
- Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined. While there are reportedly increased risks of head and neck cancer associated with sustained heavy cigar and pipe use (Wyss 2013), such sustained use of non-cigarette products is unusual and does not appear to convey added risk with synchronous cigarette smoking. Cigar and pipe tobacco consumption is therefore not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is no clear scientific evidence regarding the role of chewing tobacco-containing products in this disease, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone
- Zubrod performance status of 0-1 within 14 days prior to registration
- Absolute neutrophil count >= 1,500/mcL (within 14 days prior to registration)
- Platelets >= 100,000/mcL (within 14 days prior to registration)
- Hemoglobin >= 8.0 g/dL (within 14 days prior to registration) (Note: use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 14 days prior to registration)
- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN (within 14 days prior to registration)
- Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) (within 14 days prior to registration)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
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 for the hepatitis, they are eligible if they have an undetectable HCV viral load.
- Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
For women of childbearing potential (WOCBP), negative serum or urine pregnancy test within 24 hours prior to registration
- Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
- Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must be willing to use an adequate method of contraception during and after treatment
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
- Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available
Exclusion Criteria:
- Clinical stages T0; T4; T1-2, N0; or any N2 (AJCC, 8th ed)
- Recurrent disease
- Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
- Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
- Carcinoma of the neck of unknown primary site origin (T0 is ineligible, even if p16-positive)
- Radiographically matted nodes, defined as 3 abutting nodes with loss of the intervening fat plane
- Supraclavicular nodes, defined as nodes centered below the level of the cricoid cartilage
- Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed
- Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (of note, the exclusion applies only for invasive cancers such that carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- History of severe hypersensitivity reaction to any monoclonal antibody.
Severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise greater than that noted; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients
- Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- Patients with active autoimmune disease requiring systemic treatment (i.e. disease modifying agents, corticosteroids, or immunosuppressive drugs) 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), rheumatoid arthritis, connective tissue diseases, 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
- Note: 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)
- Patients who are pregnant, nursing, or expecting to conceive or father children
- Prior allergic reaction to cisplatin
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Banner MD Anderson Cancer CenterRecruiting
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- Kaiser Permanente-Deer Valley Medical CenterRecruiting
- PCR OncologyRecruiting
- Sutter Auburn Faith HospitalRecruiting
- Sutter Cancer Centers Radiation Oncology Services-AuburnRecruiting
- AIS Cancer Center at San Joaquin Community HospitalRecruiting
- Tower Cancer Research FoundationRecruiting
- Sutter Cancer Centers Radiation Oncology Services-Cameron ParkRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- Kaiser Permanente DublinRecruiting
- UC San Diego Health System - EncinitasRecruiting
- Kaiser Permanente-FremontRecruiting
- Fresno Cancer CenterRecruiting
- Kaiser Permanente-FresnoRecruiting
- City of Hope at Irvine LennarRecruiting
- UC San Diego Moores Cancer CenterRecruiting
- City of Hope Antelope ValleyRecruiting
- Los Angeles County-USC Medical CenterRecruiting
- USC / Norris Comprehensive Cancer CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- Fremont - Rideout Cancer CenterRecruiting
- Kaiser Permanente-ModestoRecruiting
- Palo Alto Medical Foundation-Camino DivisionRecruiting
- Kaiser Permanente Oakland-BroadwayRecruiting
- Kaiser Permanente-OaklandRecruiting
- Palo Alto Medical Foundation Health CareRecruiting
- Stanford Cancer Institute Palo AltoRecruiting
- Kaiser Permanente-Rancho Cordova Cancer CenterRecruiting
- Kaiser Permanente- Marshall Medical OfficesRecruiting
- Kaiser Permanente-RichmondRecruiting
- Rohnert Park Cancer CenterRecruiting
- Kaiser Permanente-RosevilleRecruiting
- Sutter Cancer Centers Radiation Oncology Services-RosevilleRecruiting
- Sutter Roseville Medical CenterRecruiting
- The Permanente Medical Group-Roseville Radiation OncologyRecruiting
- Kaiser Permanente Downtown CommonsRecruiting
- Sutter Medical Center SacramentoRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-South SacramentoRecruiting
- South Sacramento Cancer CenterRecruiting
- UC San Diego Medical Center - Hillcrest
- Naval Medical Center -San Diego
- Kaiser Permanente-San FranciscoRecruiting
- UCSF Medical Center-Mission BayRecruiting
- Kaiser Permanente-Santa Teresa-San JoseRecruiting
- Stanford Cancer Center South BayRecruiting
- Kaiser Permanente San LeandroRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Kaiser San Rafael-GallinasRecruiting
- Kaiser Permanente Medical Center - Santa ClaraRecruiting
- Kaiser Permanente-Santa RosaRecruiting
- City of Hope South PasadenaRecruiting
- Kaiser Permanente Cancer Treatment CenterRecruiting
- Kaiser Permanente-South San FranciscoRecruiting
- Kaiser Permanente-StocktonRecruiting
- Palo Alto Medical Foundation-SunnyvaleRecruiting
- City of Hope South BayRecruiting
- Torrance Memorial Physician Network - Cancer CareRecruiting
- Torrance Memorial Medical CenterRecruiting
- City of Hope UplandRecruiting
- Kaiser Permanente Medical Center-VacavilleRecruiting
- Kaiser Permanente-VallejoRecruiting
- Kaiser Permanente-Walnut CreekRecruiting
- Rocky Mountain Regional VA Medical CenterRecruiting
- UCHealth University of Colorado Hospital
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- UCHealth Memorial Hospital Central
- Memorial Hospital North
- Porter Adventist HospitalRecruiting
- Poudre Valley Hospital
- Cancer Care and Hematology-Fort Collins
- UCHealth Greeley Hospital
- Littleton Adventist HospitalRecruiting
- Medical Center of the Rockies
- Parker Adventist HospitalRecruiting
- Hartford HospitalRecruiting
- Delaware Clinical and Laboratory Physicians PARecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Christiana Care Health System-Christiana HospitalRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral SpringsRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- Jupiter Medical CenterRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- Miami Cancer InstituteRecruiting
- UM Sylvester Comprehensive Cancer Center at KendallRecruiting
- Orlando Health Cancer InstituteRecruiting
- Moffitt Cancer Center-International PlazaRecruiting
- Moffitt Cancer Center - McKinley CampusRecruiting
- Moffitt Cancer CenterRecruiting
- Moffitt Cancer Center at Wesley ChapelRecruiting
- Grady Health SystemRecruiting
- Emory University Hospital MidtownRecruiting
- Hawaii Cancer Care - WestridgeRecruiting
- Pali Momi Medical CenterRecruiting
- 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
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical CenterRecruiting
- Queen's Cancer Center - KuakiniRecruiting
- The Cancer Center of Hawaii-LilihaRecruiting
- Kaiser Permanente Moanalua Medical CenterRecruiting
- 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
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Rush - Copley Medical CenterRecruiting
- Advocate Good Shepherd HospitalRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Northwestern UniversityRecruiting
- Rush University Medical Center
- Advocate Illinois Masonic Medical CenterRecruiting
- AMG Crystal Lake - OncologyRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Advocate Good Samaritan HospitalRecruiting
- Crossroads Cancer CenterRecruiting
- Advocate Sherman HospitalRecruiting
- Illinois CancerCare-EurekaRecruiting
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Illinois CancerCare-MacombRecruiting
- Loyola University Medical CenterRecruiting
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Advocate Lutheran General HospitalRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Illinois CancerCare-PeruRecruiting
- Illinois CancerCare-PrincetonRecruiting
- SwedishAmerican Regional Cancer Center/ACTRecruiting
- Memorial Hospital EastRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Illinois CancerCare - WashingtonRecruiting
- IU Health North HospitalRecruiting
- Indiana University/Melvin and Bren Simon Cancer CenterRecruiting
- Sidney and Lois Eskenazi HospitalRecruiting
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Greater Regional Medical Center
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran HospitalRecruiting
- Methodist West HospitalRecruiting
- Mercy Medical Center-West Lakes
- University of Kansas Cancer CenterRecruiting
- Lawrence Memorial Hospital
- Olathe Health Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- Salina Regional Health CenterRecruiting
- University of Kansas Health System Saint Francis CampusRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- University of Kentucky/Markey Cancer Center
- Jewish Hospital
- Norton Hospital Pavilion and Medical CampusRecruiting
- The James Graham Brown Cancer Center at University of LouisvilleRecruiting
- Norton Brownsboro Hospital and Medical CampusRecruiting
- LSU Health Baton Rouge-North Clinic
- Louisiana Hematology Oncology Associates LLC
- Mary Bird Perkins Cancer Center
- Our Lady of the Lake Physicians Group - Medical Oncology
- East Jefferson General Hospital
- MaineHealth Coastal Cancer Treatment Center
- MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
- Maine Medical Center-Bramhall Campus
- Penobscot Bay Medical Center
- MaineHealth Cancer Care Center of York County
- MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
- Maine Medical Center- Scarborough Campus
- Maine Medical Partners - South Portland
- University of Maryland/Greenebaum Cancer Center
- Greater Baltimore Medical CenterRecruiting
- UM Upper Chesapeake Medical Center
- Boston Medical Center
- Dana-Farber Cancer InstituteRecruiting
- Saint Joseph Mercy HospitalRecruiting
- McLaren Cancer Institute-Bay CityRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Henry Ford Cancer Institute-DownriverRecruiting
- 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
- McLaren Cancer Institute-ClarkstonRecruiting
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Henry Ford Medical Center-FairlaneRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Henry Ford HospitalRecruiting
- Weisberg Cancer Treatment 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
- Karmanos Cancer Institute at McLaren Greater LansingRecruiting
- Mid-Michigan Physicians-LansingRecruiting
- Sparrow HospitalRecruiting
- McLaren Cancer Institute-Lapeer RegionRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- McLaren Cancer Institute-MacombRecruiting
- Lakeland Hospital NilesRecruiting
- Henry Ford Medical Center-ColumbusRecruiting
- McLaren Cancer Institute-Northern MichiganRecruiting
- McLaren-Port HuronRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Lakeland Medical Center Saint JosephRecruiting
- Marie Yeager Cancer CenterRecruiting
- Henry Ford Macomb Health Center - Shelby Township
- Ascension Saint Joseph HospitalRecruiting
- Henry Ford West Bloomfield HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- University of Michigan Health - WestRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Essentia Health Saint Joseph's Medical CenterRecruiting
- Essentia Health - Deer River ClinicRecruiting
- Essentia Health Cancer CenterRecruiting
- Essentia Health Saint Mary's Medical CenterRecruiting
- Miller-Dwan HospitalRecruiting
- Essentia Health Hibbing ClinicRecruiting
- Coborn Cancer Center at Saint Cloud HospitalRecruiting
- Essentia Health SandstoneRecruiting
- Essentia Health Virginia ClinicRecruiting
- Saint Francis Medical CenterRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Freeman Health SystemRecruiting
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- University of Kansas Cancer Center at North Kansas City HospitalRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Washington University School of MedicineRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- CHI Health Good SamaritanRecruiting
- University of Nebraska Medical CenterRecruiting
- Renown Regional Medical CenterRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Community Medical CenterRecruiting
- University of New Mexico Cancer CenterRecruiting
- New Mexico Oncology Hematology ConsultantsRecruiting
- Sands Cancer CenterRecruiting
- Noyes Memorial Hospital/Myers Cancer CenterRecruiting
- Upstate Cancer Center at OswegoRecruiting
- Highland HospitalRecruiting
- University of RochesterRecruiting
- Stony Brook University Medical CenterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- SUNY Upstate Medical Center-Community CampusRecruiting
- Upstate Cancer Center Hematology Oncology at VeronaRecruiting
- Wilmot Cancer Institute at WebsterRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Novant Health Presbyterian Medical CenterRecruiting
- Atrium Health Pineville/LCI-PinevilleRecruiting
- Atrium Health University City/LCI-UniversityRecruiting
- Levine Cancer Institute-BallantyneRecruiting
- Wake Forest University at ClemmonsRecruiting
- Atrium Health Cabarrus/LCI-ConcordRecruiting
- CaroMont Regional Medical Center
- East Carolina UniversityRecruiting
- Novant Health Cancer Institute - HuntersvilleRecruiting
- Novant Health Presbyterian Medical Center HuntersvilleRecruiting
- Novant Health Cancer Institute - KernersvilleRecruiting
- Novant Health Cancer Institute - MatthewsRecruiting
- Atrium Health Union/LCI-UnionRecruiting
- Novant Health Cancer Institute - MooresvilleRecruiting
- Novant Health Cancer Institute - Mount AiryRecruiting
- FirstHealth of the Carolinas-Moore Regional HospitalRecruiting
- Novant Health Cancer Institute - StatesvilleRecruiting
- Wake Forest Baptist Health - Hematology Oncology - StatesvilleRecruiting
- Novant Cancer Institute Radiation Oncology - SupplyRecruiting
- Novant Health Cancer Institute - ThomasvilleRecruiting
- Novant Health Cancer Institute - WilkesboroRecruiting
- Wake Forest Baptist Health - Wilkes Medical CenterRecruiting
- Novant Health Cancer Institute Radiation Oncology - WilmingtonRecruiting
- Novant Health New Hanover Regional Medical CenterRecruiting
- Novant Health Forsyth Medical CenterRecruiting
- Wake Forest University Health SciencesRecruiting
- Sanford Bismarck Medical CenterRecruiting
- 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
- Geauga HospitalRecruiting
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- Case Western Reserve UniversityRecruiting
- MetroHealth Medical CenterRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- 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
- Mercy Health Perrysburg Cancer CenterRecruiting
- University Hospitals Portage Medical CenterRecruiting
- North Coast Cancer CareRecruiting
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- ProMedica Flower HospitalRecruiting
- Saint Vincent Mercy Medical CenterRecruiting
- Mercy Health - Saint Anne HospitalRecruiting
- University of Cincinnati Cancer Center-West ChesterRecruiting
- UH Seidman Cancer Center at Saint John Medical CenterRecruiting
- UHHS-Westlake Medical CenterRecruiting
- Cleveland Clinic Wooster Family Health and Surgery CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Providence Newberg Medical CenterRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Kaiser Permanente NorthwestRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- UPMC AltoonaRecruiting
- UPMC-Heritage Valley Health System BeaverRecruiting
- Carlisle Regional Cancer CenterRecruiting
- Christiana Care Health System-Concord Health CenterRecruiting
- Chambersburg HospitalRecruiting
- Geisinger Medical CenterRecruiting
- Fox Chase Cancer Center - East Norriton Hospital Outpatient CenterRecruiting
- Ephrata Cancer CenterRecruiting
- UPMC Hillman Cancer Center ErieRecruiting
- UPMC Cancer Center at UPMC HorizonRecruiting
- Fox Chase Cancer Center BuckinghamRecruiting
- Adams Cancer CenterRecruiting
- UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
- UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- UPMC-Johnstown/John P. Murtha Regional Cancer CenterRecruiting
- Geisinger Medical Oncology-LewisburgRecruiting
- Lewistown HospitalRecruiting
- UPMC Cancer Center at UPMC McKeesport
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
- Forbes HospitalRecruiting
- UPMC Cancer Center - MonroevilleRecruiting
- UPMC Hillman Cancer Center in CoraopolisRecruiting
- Thomas Jefferson University HospitalRecruiting
- Fox Chase Cancer CenterRecruiting
- Jefferson Torresdale HospitalRecruiting
- Temple University Hospital
- Allegheny General HospitalRecruiting
- UPMC-Magee Womens HospitalRecruiting
- UPMC-Saint MargaretRecruiting
- UPMC-Shadyside HospitalRecruiting
- UPMC-Passavant HospitalRecruiting
- UPMC-Saint Clair Hospital Cancer CenterRecruiting
- Geisinger Cancer Services-PottsvilleRecruiting
- UPMC Cancer Center at UPMC NorthwestRecruiting
- UPMC Uniontown Hospital Radiation OncologyRecruiting
- UPMC Washington Hospital Radiation OncologyRecruiting
- Reading HospitalRecruiting
- Wexford Health and Wellness PavilionRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Divine Providence HospitalRecruiting
- Asplundh Cancer PavilionRecruiting
- WellSpan Health-York Cancer CenterRecruiting
- WellSpan Health-York HospitalRecruiting
- UPMC MemorialRecruiting
- Medical University of South CarolinaRecruiting
- Gibbs Cancer Center-GaffneyRecruiting
- Tidelands Georgetown Memorial HospitalRecruiting
- Saint Francis HospitalRecruiting
- Prisma Health Cancer Institute - FarisRecruiting
- Saint Francis Cancer CenterRecruiting
- Prisma Health Cancer Institute - EastsideRecruiting
- Prisma Health Cancer Institute - GreerRecruiting
- Gibbs Cancer Center-PelhamRecruiting
- Rock Hill Radiation Therapy CenterRecruiting
- Levine Cancer Institute-Rock HillRecruiting
- Prisma Health Cancer Institute - SenecaRecruiting
- Spartanburg Medical CenterRecruiting
- MGC Hematology Oncology-UnionRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer InstituteRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- The West Clinic - Wolf RiverRecruiting
- University of Tennessee - KnoxvilleRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- The Don and Sybil Harrington Cancer CenterRecruiting
- American Fork Hospital / Huntsman Intermountain Cancer CenterRecruiting
- Farmington Health CenterRecruiting
- Logan Regional HospitalRecruiting
- Intermountain Medical CenterRecruiting
- McKay-Dee Hospital CenterRecruiting
- Utah Valley Regional Medical CenterRecruiting
- Riverton HospitalRecruiting
- Saint George Regional Medical CenterRecruiting
- Utah Cancer Specialists-Salt Lake CityRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- LDS HospitalRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- Inova Schar Cancer InstituteRecruiting
- Inova Fair Oaks HospitalRecruiting
- Naval Medical Center - PortsmouthRecruiting
- VCU Massey Cancer Center at Stony PointRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Valley Medical CenterRecruiting
- Swedish Medical Center-Ballard CampusRecruiting
- Swedish Medical Center-First HillRecruiting
- Providence Saint Mary Regional Cancer CenterRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- Ascension Saint Elizabeth HospitalRecruiting
- Duluth Clinic AshlandRecruiting
- Northwest Wisconsin Cancer CenterRecruiting
- Ascension Southeast Wisconsin Hospital - Elmbrook CampusRecruiting
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- Ascension Calumet HospitalRecruiting
- HSHS Sacred Heart HospitalRecruiting
- Ascension Saint Francis - Reiman Cancer CenterRecruiting
- Ascension Southeast Wisconsin Hospital - FranklinRecruiting
- 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
- Essentia Health-Hayward ClinicRecruiting
- UW Cancer Center Johnson CreekRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Froedtert Menomonee Falls HospitalRecruiting
- Ascension Columbia Saint Mary's Hospital OzaukeeRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Ascension Southeast Wisconsin Hospital - Saint Joseph CampusRecruiting
- Ascension Columbia Saint Mary's Hospital - MilwaukeeRecruiting
- Ascension Saint Francis HospitalRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Medical College of WisconsinRecruiting
- Aurora Sinai Medical CenterRecruiting
- Ascension Mercy HospitalRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Ascension All Saints HospitalRecruiting
- Aurora Cancer Care-RacineRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Essentia Health-Spooner ClinicRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Aurora Medical Center in SummitRecruiting
- Essentia Health Saint Mary's Hospital - SuperiorRecruiting
- Vince Lombardi Cancer Clinic-Two RiversRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Ascension Medical Group Southeast Wisconsin - Mayfair RoadRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- University Health Network-Princess Margaret HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm I (IMRT, IGRT, cisplatin)
Arm II (IMRT, IGRT, cisplatin)
Arm III (IMRT, IGRT, nivolumab)
Patients undergo IMRT or IGRT over 6 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Patients undergo reduced dose IMRT or IGRT QD over 5 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Beginning 1 week prior to radiation, patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.