Testing Pembrolizumab Versus Observation in Patients With Merkel Cell Carcinoma After Surgery, STAMP Study
Pathologic Stage I Merkel Cell Carcinoma AJCC v8, Pathologic Stage II Merkel Cell Carcinoma AJCC v8, Pathologic Stage III Merkel Cell Carcinoma AJCC v8
About this trial
This is an interventional treatment trial for Pathologic Stage I Merkel Cell Carcinoma AJCC v8
Eligibility Criteria
Inclusion Criteria:
- Patient must be >= 18 years of age
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1, or 2 (However, those patients with a performance state of 3 because they are wheel chair bound due to congenital or traumatic events more than one year before the diagnosis of Merkel cell carcinoma are eligible).
Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (American Joint Committee on Cancer [AJCC] version 8) I-IIIb.
- Stage I patients with negative sentinel lymph node biopsy are ineligible. Patients who have a positive biopsy or for whom no biopsy was done are eligible.
- Patients with distant metastatic disease (stage IV) are ineligible.
- The primary tumor must have grossly negative margins. (Microscopically positive margins are allowed).
- Cancers of unknown primary that have regional disease only are eligible.
- Complete nodal dissection is not required for eligibility.
- Patients with all macroscopic Merkel cell carcinoma (either identified by physical exam or imaging) have been completely resected by surgery within 16 weeks before randomization.
- All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 8 weeks prior to randomization.
Patient may not have a history of distant metastatic disease.
- NOTE: Loco-regional recurrent disease is acceptable, as long as this is not metastatic (prior surgery with or without radiation therapy is acceptable).
- For patients with initial presentation of Merkel cell carcinoma, patient must have no previous systemic therapy or radiation therapy prior to surgery for Merkel cell carcinoma and cannot have completed adjuvant radiation therapy for Merkel cell carcinoma more than 6 weeks prior to randomization. Patients actively undergoing radiation therapy or having completed adjuvant radiation therapy within 6 weeks of randomization are eligible, as long as resection date is within 16 weeks of randomization. Patients with prior radiation at a non-Radiation Oncology Core (IROC) provider are eligible for the trial. If the patient has not received radiation, and treatment at a Radiation Oncology Core (IROC) provider is not possible, the patient can start and complete radiation prior to randomization, with recommendations to follow radiation protocol guidelines with submission of treatment records.
- White blood count >= 2000/uL (within 4 weeks prior to randomization).
- Absolute neutrophil count (ANC) >= 1000/uL (within 4 weeks prior to randomization).
- Platelets >= 75 x 10^3/uL (within 4 weeks prior to randomization).
- Hemoglobin >= 8 g/dL (>= 80 g/L; may be transfused) (within 4 weeks prior to randomization).
- Creatinine =< 2.0 x institutional upper limit of normal (ULN) (within 4 weeks prior to randomization).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN (within 4 weeks prior to randomization).
- Total bilirubin =< 2.0 x institutional ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL) (within 4 weeks prior to randomization).
- Patients who are human immunodeficiency virus (HIV)+ with undetectable HIV viral load are eligible provided they meet all other protocol criteria for participation.
- Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are eligible provided viral loads are undetectable. Patients on suppressive therapy are eligible.
Exclusion Criteria:
- Patient must not be pregnant or breast-feeding due to the unknown effects of the study drug in this setting. 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 anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Patients on Arm A MK-3475 (Pembrolizumab) 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 registration, while on study treatment, and continue for 120 days after the last dose of study treatment. For patients on Arm B only receiving radiation therapy, contraception use should be per institutional standard.
- Patients must not be on active immunosuppression, have a history of life threatening virus, have had other (beside non-melanoma skin cancers, or recent indolent cancers e.g.: resected low grade prostate cancer) invasive cancer diagnoses in the last two years, or have had immunotherapy of any kind within the last 2 years prior to randomization.
- Patients must not have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Operative notes from patient's surgical resection must be accessible.
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Kingman Regional Medical Center
- Mayo Clinic Hospital in Arizona
- Mayo Clinic in Arizona
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Mercy Hospital Fort Smith
- PCR Oncology
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Alta Bates Summit Medical Center-Herrick Campus
- Keck Medicine of USC Buena Park
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Eden Hospital Medical Center
- Sutter Davis Hospital
- Palo Alto Medical Foundation-Fremont
- Keck Medicine of USC Huntington Beach
- UC San Diego Moores Cancer Center
- Keck Medicine of USC Koreatown
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- USC Norris Oncology/Hematology-Newport Beach
- Sutter Cancer Research Consortium
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- VA Palo Alto Health Care System
- Keck Medical Center of USC Pasadena
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Sutter Medical Center Sacramento
- California Pacific Medical Center-Pacific Campus
- Palo Alto Medical Foundation-Santa Cruz
- Sutter Pacific Medical Foundation
- Palo Alto Medical Foundation-Sunnyvale
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Sutter Solano Medical Center/Cancer Center
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Boulder Community Foothills Hospital
- Rocky Mountain Cancer Centers-Boulder
- Rocky Mountain Cancer Centers - Centennial
- Cancer Center of Colorado at Sloan's Lake
- National Jewish Health-Main Campus
- The Women's Imaging Center
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western Surgical Care
- Mountain Blue Cancer Care Center - Swedish
- Rocky Mountain Cancer Centers - Swedish
- Swedish Medical Center
- The Melanoma and Skin Cancer Institute
- National Jewish Health-Western Hematology Oncology
- SCL Health Cancer Centers of Colorado - Lutheran Medical Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Good Samaritan Medical Center
- Rocky Mountain Cancer Centers-Lakewood
- Rocky Mountain Cancer Centers-Littleton
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- McKee Medical Center
- National Jewish Health-Northern Hematology Oncology
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- MedStar Georgetown University Hospital
- Sibley Memorial Hospital
- UM Sylvester Comprehensive Cancer Center at Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- Holy Cross Hospital
- Regional Cancer Center-Lee Memorial Health System
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Miami Cancer Institute
- Orlando Health Cancer Institute
- UM Sylvester Comprehensive Cancer Center at Plantation
- Moffitt Cancer Center-International Plaza
- Moffitt Cancer Center - McKinley Campus
- Moffitt Cancer Center
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Summit Cancer Care-Candler
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Alphonsus Cancer Care Center-Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Saint Mary's Hospital
- Northwestern University
- Rush University Medical Center
- University of Chicago Comprehensive Cancer Center
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Illinois CancerCare-Dixon
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Kewanee Clinic
- Northwestern Medicine Lake Forest Hospital
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Cancer Care Center of O'Fallon
- University of Chicago Medicine-Orland Park
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Illinois CancerCare - Washington
- Rush-Copley Healthcare Center
- Indiana University/Melvin and Bren Simon Cancer Center
- Memorial Hospital of South Bend
- Saint Anthony Regional Hospital
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Jennie Edmundson Memorial Hospital
- Heartland Oncology and Hematology LLP
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Iowa Lutheran Hospital
- Trinity Regional Medical Center
- Methodist West Hospital
- Coffeyville Regional Medical Center
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- HaysMed University of Kansas Health System
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- Ascension Via Christi - Pittsburg
- Salina Regional Health Center
- University of Kansas Health System Saint Francis Campus
- University of Kansas Hospital-Westwood Cancer Center
- Mercy Health - Paducah Medical Oncology and Hematology
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Lafayette Family Cancer Center-EMMC
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
- Mercy Medical Center
- Baystate Medical Center
- Saint Joseph Mercy Hospital
- Bronson Battle Creek
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Caro Cancer Center
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Ascension Borgess Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton Shores
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Huron Medical Center PC
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph Hospital
- Munson Medical Center
- 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 Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- University of Michigan Health - West
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Riverwood Healthcare Center
- Essentia Health - Baxter Clinic
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Minnesota Oncology - Burnsville
- Cambridge Medical Center
- Mercy Hospital
- Essentia Health - Deer River Clinic
- Essentia Health Saint Mary's - Detroit Lakes Clinic
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Saint Luke's Hospital of Duluth
- Fairview Southdale Hospital
- Essentia Health - Ely Clinic
- Lake Region Healthcare Corporation-Cancer Care
- Essentia Health - Fosston
- Unity Hospital
- Essentia Health Hibbing Clinic
- Essentia Health - International Falls Clinic
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- Essentia Health - Moose Lake Clinic
- New Ulm Medical Center
- Essentia Health - Park Rapids
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Essentia Health Sandstone
- Lakeview Hospital
- Sanford Thief River Falls Medical Center
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Sanford Cancer Center Worthington
- Fairview Lakes Medical Center
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - Farmington
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Truman Medical Centers
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center at North Kansas City Hospital
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
- Nebraska Methodist Hospital
- Oncology Associates PC
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- 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 Charleston
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- Urology Specialists of Nevada - Central
- GenesisCare USA - Las Vegas
- 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 Southeast
- Ann M Wierman MD LTD
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- 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 MountainView
- Urology Specialists of Nevada - Northwest
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Comprehensive Cancer Centers of Nevada - Town Center
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- Hackensack University Medical Center
- Saint Barnabas Medical Center
- Morristown Medical Center
- Rutgers Cancer Institute of New Jersey
- Overlook Hospital
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- University of Rochester
- Stony Brook University Medical Center
- Messino Cancer Centers
- Wake Forest University at Clemmons
- Duke University Medical Center
- East Carolina University
- Margaret R Pardee Memorial Hospital
- Wake Forest Baptist Health - Hematology Oncology - Statesville
- Wake Forest Baptist Health - Wilkes Medical Center
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford South University Medical Center
- Sanford Medical Center Fargo
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Altru Cancer Center
- Essentia Health - Jamestown Clinic
- UH Seidman Cancer Center at UH Avon Health Center
- UHHS-Chagrin Highlands Medical Center
- Geauga Hospital
- University of Cincinnati Cancer Center-UC Medical Center
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- University Hospitals Parma Medical Center
- University Hospitals Portage Medical Center
- North Coast Cancer Care
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Cleveland Clinic Cancer Center Strongsville
- University Hospitals Sharon Health Center
- University of Cincinnati Cancer Center-West Chester
- UH Seidman Cancer Center at Saint John Medical Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Oregon Health and Science University
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar Crest
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Medical Center
- Pocono Medical Center
- UPMC Cancer Center at UPMC Horizon
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Geisinger Medical Center-Cancer Center Hazleton
- Lehigh Valley Hospital-Hazleton
- Penn State Milton S Hershey Medical Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- UPMC Hillman Cancer Center - Part of Frick Hospital
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC-Passavant Hospital
- Geisinger Cancer Services-Pottsville
- Community Medical Center
- Geisinger Medical Oncology-Selinsgrove
- Geisinger Medical Group
- UPMC Cancer Center-Washington
- UPMC Washington Hospital Radiation Oncology
- Geisinger Wyoming Valley/Henry Cancer Center
- Saint Joseph's/Candler - Bluffton Campus
- Medical University of South Carolina
- Gibbs Cancer Center-Gaffney
- Tidelands Georgetown Memorial Hospital
- Saint Francis Hospital
- Saint Francis Cancer Center
- Gibbs Cancer Center-Pelham
- South Carolina Cancer Specialists PC
- North Grove Medical Park
- Spartanburg Medical Center
- Spartanburg Medical Center - Mary Black Campus
- MGC Hematology Oncology-Union
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- University of Tennessee - Knoxville
- UT Southwestern/Simmons Cancer Center-Dallas
- Huntsman Cancer Institute/University of Utah
- University of Virginia Cancer Center
- Inova Schar Cancer Institute
- Virginia Commonwealth University/Massey Cancer Center
- Providence Regional Cancer System-Aberdeen
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Providence Regional Cancer Partnership
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-Lacey
- PeaceHealth Saint John Medical Center
- Jefferson Healthcare
- Valley Medical Center
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- FHCC South Lake Union
- Fred Hutchinson Cancer Research Center
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Montlake
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- ThedaCare Regional Cancer Center
- Duluth Clinic Ashland
- Northwest Wisconsin Cancer Center
- Marshfield Medical Center-EC Cancer Center
- Mayo Clinic Health System-Eau Claire Clinic
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Essentia Health-Hayward Clinic
- Gundersen Lutheran Medical Center
- University of Wisconsin Carbone Cancer Center
- Marshfield Medical Center-Marshfield
- Froedtert Menomonee Falls Hospital
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Marshfield Medical Center-Rice Lake
- Essentia Health-Spooner Clinic
- Marshfield Medical Center-River Region at Stevens Point
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Essentia Health Saint Mary's Hospital - Superior
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Froedtert West Bend Hospital/Kraemer Cancer Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A (pembrolizumab, radiation therapy)
Arm B (standard of care observation, radiation therapy)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. Patients undergo PET-CT or CT on a 6 month basis through 5 years.
Patients receive standard of care observation every 3 months for 1 year, and then every 6 months for 5 years. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. Patients undergo PET-CT or CT on a 6 month basis through 5 years.