Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
Advanced Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
About this trial
This is an interventional treatment trial for Advanced Melanoma
Eligibility Criteria
Inclusion Criteria:
- STEP 0 PRE-REGISTRATION INCLUSION CRITERIA
- Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition
- Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible. Patients must not have melanoma from an ocular primary site
- Patient must have had measurable disease by immune related Response Evaluation Criteria in Solid Tumors (imRECIST) prior to start of initial anti-PD-1 therapy
Patient must be actively receiving standard of care anti-PD-1 therapy, currently be 52 weeks (+/- 2 weeks) from start of anti-PD-1 therapy, and have not experienced a toxicity that prevents them from continuing on therapy. Permitted systemic anti-PD-1 therapy regimens include:
- Nivolumab 240 mg IV every (Q)2weeks or 480 mg IV Q4weeks
- Pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks
- Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance
- Nivolumab 3 mg/kg plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance
- Pembrolizumab 2 mg/kg (or 200 mg flat dose) plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks maintenance
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients with detectable viral loads are excluded as it is unclear if these patients have a low risk of melanoma progression off anti-PD-1 treatment
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- Patient must have experienced complete response, partial response, or stable disease on restaging CT scans by imRECIST that is maintained on restaging scans obtained at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy
Patient must have completed an FDG-PET/CT scan at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy
Patients with PET/CT positive for hypermetabolic lesions: If a core needle, punch or excisional biopsy and pathological review of a representative lesion was not performed prior to pre-registration (Step 0) must either:
- Be amenable to undergo a biopsy. Patient must not be on anticoagulation therapy or, if on anti-coagulation therapy, patient must be able to hold treatment for a biopsy procedure (core needle, punch or excisional biopsy). Anti-coagulation therapy is defined as low molecular weight heparin, warfarin, factor Xa inhibitor, or direct thrombin inhibitor
- Have documentation of inability to perform the biopsy due to feasibility or safety concerns
- Leukocytes >= 3,000/mcL (obtained =< 4 weeks prior to protocol registration)
- Absolute neutrophil count >= 1,500/mcL (obtained =< 4 weeks prior to protocol registration)
- Platelets >= 100,000/mcL (obtained =< 4 weeks prior to protocol registration)
- Total bilirubin =< institutional upper limit of normal (ULN) (patients with history of Gilbert's syndrome are permitted to have a total bilirubin > 1.5 x institutional ULN) (obtained =< 4 weeks prior to protocol registration)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 4 weeks prior to protocol registration)
- Creatinine =< 1.5 x institutional ULN (obtained =< 4 weeks prior to protocol registration)
- STEP 1 REGISTRATION INCLUSION CRITERIA
- Patient met all eligibility criteria outlined above
- Patient must register to Step 1 within 4 weeks of registration to Step 0
Patients must meet one of the following criteria:
- Patient had no positive hypermetabolic lesions on the week 52 FDG-PET/CT.
Patients with positive hypermetabolic lesion(s) on the week 52 FDG-PET/CT (positive hypermetabolic = standard uptake volume [SUV] > pooled mediastinal blood), one of the following must have occurred:
- A representative lesion was biopsied (core needle, punch or excisional biopsy) within 14 days of registration to Step 0 and subsequent pathology review performed to determine the presence or absence of viable tumor
- Documentation is present that the patient is not able to undergo biopsy of a hypermetabolic lesion due to feasibility or safety concerns, i.e., the lesion location that is not amenable to biopsy
Exclusion Criteria:
- STEP 0 PRE-REGISTRATION EXCLUSION CRITERIA
- Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients who are receiving bisphosphonates and RANKL inhibitors for management of bone metastases are eligible
- Patient must not have brain metastases
- Women must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the anti-PD-1 regimens being used. All females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A female of childbearing potential is defined as any woman, 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)
- Women of childbearing potential and sexually active males must not conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of study registration and continuing until at least 5 months after the last dose of anti-PD-1 treatment for female patients and for at least 7 months after the last dose of anti-PD-1 treatment for male patients who are sexually active with a women of childbearing potential (WOCBP)
Sites / Locations
- Fairbanks Memorial HospitalRecruiting
- Cancer Center at Saint Joseph'sRecruiting
- Mercy Hospital Fort SmithRecruiting
- CHI Saint Vincent Cancer Center Hot Springs
- University of Arkansas for Medical SciencesRecruiting
- Mission Hope Medical Oncology - Arroyo GrandeRecruiting
- Cedars Sinai Medical CenterRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Rocky Mountain Cancer Centers-AuroraRecruiting
- The Medical Center of AuroraRecruiting
- Boulder Community Foothills HospitalRecruiting
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Rocky Mountain Cancer Centers - CentennialRecruiting
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- Saint Francis Cancer CenterRecruiting
- The Women's Imaging CenterRecruiting
- Porter Adventist HospitalRecruiting
- Colorado Blood Cancer InstituteRecruiting
- Presbyterian - Saint Lukes Medical Center - Health OneRecruiting
- Rocky Mountain Cancer Centers-MidtownRecruiting
- Rocky Mountain Cancer Centers-RoseRecruiting
- Rose Medical CenterRecruiting
- Western Surgical CareRecruiting
- Mercy Medical CenterRecruiting
- Southwest Oncology PCRecruiting
- Mountain Blue Cancer Care Center - SwedishRecruiting
- Rocky Mountain Cancer Centers - SwedishRecruiting
- Swedish Medical CenterRecruiting
- The Melanoma and Skin Cancer InstituteRecruiting
- Rocky Mountain Cancer Centers-LakewoodRecruiting
- Saint Anthony HospitalRecruiting
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Littleton Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Sky RidgeRecruiting
- Sky Ridge Medical CenterRecruiting
- Longmont United HospitalRecruiting
- Rocky Mountain Cancer Centers-Longmont
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical CenterRecruiting
- Rocky Mountain Cancer Centers-ThorntonRecruiting
- MedStar Georgetown University HospitalRecruiting
- MedStar Washington Hospital CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at AventuraRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- Holy Cross HospitalRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at KendallRecruiting
- UM Sylvester Comprehensive Cancer Center at PlantationRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
- Saint Anthony's HealthRecruiting
- Rush - Copley Medical Center
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Northwestern UniversityRecruiting
- Carle on Vermilion
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Illinois CancerCare-DixonRecruiting
- Carle Physician Group-Effingham
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Northwestern Medicine Lake Forest Hospital
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/Charleston
- Good Samaritan Regional Health CenterRecruiting
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- 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 Center
- The Carle Foundation Hospital
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare Center
- Reid HealthRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic PC - AmesRecruiting
- McFarland Clinic PC-BooneRecruiting
- Saint Anthony Regional HospitalRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Alegent Health Mercy HospitalRecruiting
- Greater Regional Medical CenterRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical Center
- Medical Oncology and Hematology Associates-LaurelRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Iowa Lutheran HospitalRecruiting
- McFarland Clinic PC-Trinity Cancer CenterRecruiting
- Trinity Regional Medical CenterRecruiting
- McFarland Clinic PC-JeffersonRecruiting
- McFarland Clinic PC-MarshalltownRecruiting
- Methodist West HospitalRecruiting
- Mercy Medical Center-West LakesRecruiting
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- Flaget Memorial HospitalRecruiting
- Commonwealth Cancer Center-CorbinRecruiting
- Saint Joseph Radiation Oncology Resource CenterRecruiting
- Saint Joseph Hospital EastRecruiting
- Saint Joseph LondonRecruiting
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Jewish Hospital Medical Center South
- MedStar Franklin Square Medical Center/Weinberg Cancer InstituteRecruiting
- Boston Medical CenterRecruiting
- Hickman Cancer CenterRecruiting
- Saint Joseph Mercy HospitalRecruiting
- Bronson Battle CreekRecruiting
- 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-ClarkstonRecruiting
- Newland Medical Associates-ClarkstonRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Mercy Health Saint Mary'sRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe WoodsRecruiting
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Borgess Medical CenterRecruiting
- Sparrow HospitalRecruiting
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb TownshipRecruiting
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- Toledo Clinic Cancer Centers-MonroeRecruiting
- Mercy Health Mercy CampusRecruiting
- Lakeland Hospital NilesRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer CenterRecruiting
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- 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 HeightsRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical CenterRecruiting
- Advanced Breast Care Center PLLCRecruiting
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PCRecruiting
- Michigan Breast Specialists-WarrenRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- Metro Health HospitalRecruiting
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Riverwood Healthcare CenterRecruiting
- Essentia Health - Baxter ClinicRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Essentia Health Saint Joseph's Medical CenterRecruiting
- Essentia Health - Deer River ClinicRecruiting
- Essentia Health Saint Mary's - Detroit Lakes ClinicRecruiting
- Essentia Health Cancer CenterRecruiting
- Essentia Health Saint Mary's Medical CenterRecruiting
- Miller-Dwan HospitalRecruiting
- Essentia Health - Ely ClinicRecruiting
- Lake Region Healthcare Corporation-Cancer CareRecruiting
- Essentia Health - FosstonRecruiting
- Essentia Health Hibbing ClinicRecruiting
- Essentia Health - International Falls ClinicRecruiting
- Essentia Health - Moose Lake ClinicRecruiting
- Essentia Health - Park RapidsRecruiting
- Essentia Health SandstoneRecruiting
- Sanford Thief River Falls Medical CenterRecruiting
- Essentia Health Virginia ClinicRecruiting
- Sanford Cancer Center WorthingtonRecruiting
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Cox Cancer Center BransonRecruiting
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - FarmingtonRecruiting
- 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 CityRecruiting
- Washington University School of Medicine
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South County
- Missouri Baptist Medical CenterRecruiting
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital WashingtonRecruiting
- CHI Health Saint FrancisRecruiting
- CHI Health Good SamaritanRecruiting
- Saint Elizabeth Regional Medical CenterRecruiting
- Alegent Health Immanuel Medical CenterRecruiting
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Alegent Health Lakeside HospitalRecruiting
- Creighton University Medical CenterRecruiting
- Midlands Community HospitalRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Hackensack University Medical CenterRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Roswell Park Cancer Institute
- Memorial Sloan Kettering CommackRecruiting
- Glens Falls HospitalRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Essentia Health Cancer Center-South University ClinicRecruiting
- Sanford South University Medical CenterRecruiting
- Southpointe-Sanford Medical Center FargoRecruiting
- Sanford Medical Center FargoRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Essentia Health - Jamestown ClinicRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Strecker Cancer Center-BelpreRecruiting
- Saint Elizabeth Boardman HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital South
- Adena Regional Medical CenterRecruiting
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - CincinnatiRecruiting
- Oncology Hematology Care Inc-KenwoodRecruiting
- Bethesda North HospitalRecruiting
- TriHealth Cancer Institute-WestsideRecruiting
- TriHealth Cancer Institute-AndersonRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Mount Carmel East HospitalRecruiting
- Columbus Oncology and Hematology Associates IncRecruiting
- Riverside Methodist HospitalRecruiting
- Grant Medical CenterRecruiting
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Doctors HospitalRecruiting
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer CenterRecruiting
- Grady Memorial HospitalRecruiting
- Columbus Oncology and Hematology AssociatesRecruiting
- Dublin Methodist HospitalRecruiting
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-AtriumRecruiting
- Central Ohio Breast and Endocrine SurgeryRecruiting
- Dayton Physicians LLC-WayneRecruiting
- Wayne HospitalRecruiting
- Mount Carmel Grove City HospitalRecruiting
- Greater Dayton Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- Fairfield Medical CenterRecruiting
- Saint Rita's Medical CenterRecruiting
- OhioHealth Mansfield HospitalRecruiting
- Marietta Memorial HospitalRecruiting
- OhioHealth Marion General HospitalRecruiting
- Knox Community HospitalRecruiting
- Licking Memorial HospitalRecruiting
- Newark Radiation OncologyRecruiting
- Mercy Health Perrysburg Cancer CenterRecruiting
- Southern Ohio Medical CenterRecruiting
- Springfield Regional Cancer CenterRecruiting
- Springfield Regional Medical CenterRecruiting
- Saint Vincent Mercy Medical CenterRecruiting
- Mercy Health - Saint Anne HospitalRecruiting
- Toledo Clinic Cancer Centers-ToledoRecruiting
- Dayton Physicians LLC-Upper ValleyRecruiting
- Upper Valley Medical Center
- Saint Joseph Warren HospitalRecruiting
- University of Cincinnati Cancer Center-West Chester
- Saint Ann's HospitalRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Geisinger Medical CenterRecruiting
- Pocono Medical CenterRecruiting
- Geisinger Medical Center-Cancer Center HazletonRecruiting
- Lehigh Valley Hospital-HazletonRecruiting
- Penn State Milton S Hershey Medical Center
- Geisinger Medical Oncology-LewisburgRecruiting
- Geisinger Cancer Services-PottsvilleRecruiting
- Community Medical CenterRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Gibbs Cancer Center-GaffneyRecruiting
- Gibbs Cancer Center-PelhamRecruiting
- North Grove Medical ParkRecruiting
- Spartanburg Medical CenterRecruiting
- Spartanburg Medical Center - Mary Black CampusRecruiting
- MGC Hematology Oncology-UnionRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Saint Joseph Regional Cancer CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Central Vermont Medical Center/National Life Cancer TreatmentRecruiting
- University of Vermont Medical CenterRecruiting
- University of Vermont and State Agricultural CollegeRecruiting
- University of Virginia Cancer Center
- Harrison HealthPartners Hematology and Oncology-BremertonRecruiting
- Harrison Medical CenterRecruiting
- Highline Medical Center-Main CampusRecruiting
- Saint Elizabeth HospitalRecruiting
- Saint Francis HospitalRecruiting
- Saint Clare HospitalRecruiting
- Jefferson HealthcareRecruiting
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Franciscan Research Center-Northwest Medical PlazaRecruiting
- Northwest Medical Specialties PLLC
- Duluth Clinic AshlandRecruiting
- Northwest Wisconsin Cancer CenterRecruiting
- Marshfield Clinic-Chippewa CenterRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Essentia Health-Hayward ClinicRecruiting
- Marshfield Clinic - Ladysmith CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Essentia Health-Spooner ClinicRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Essentia Health Saint Mary's Hospital - SuperiorRecruiting
- ProHealth Waukesha Memorial HospitalRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Marshfield Clinic-Wausau CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Marshfield Clinic - Wisconsin Rapids CenterRecruiting
- Cheyenne Regional Medical Center-WestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Other
Arm A (active surveillance)
Arm B (nivolumab, pembrolizumab, ipilimumab)
Standard of Care (nivolumab, pembrolizumab, ipilimumab)
Patients with a negative FDG-PET/CT scan or a positive FDG-PET/CT scan but with a negative biopsy for viable tumor discontinue the anti-PD-1 therapy and undergo active surveillance.
Patients with a positive FDG-PET/CT scan and positive biopsy for viable tumor or a positive FDG-PET/CT scan and biopsy not performed continue their standard of care anti-PD-1 therapy for 12 months in the absence of disease progression or unacceptable toxicity.
Patients continue their standard of care anti-PD-1 therapy. Treatment may consist of the following regimens: 1) nivolumab IV over 30 minutes Q2W or Q4W; 2) pembrolizumab IV over 30 minutes Q3W or Q6W; 3) nivolumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by nivolumab IV over 30 minutes Q2W or Q4W; or 4) pembrolizumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by pembrolizumab IV over 30 minutes Q3W or Q6W. Treatment continues until 52 weeks from start of standard of care anti-PD-1 therapy in the absence of disease progression or unacceptable toxicity.