Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma
Advanced Merkel Cell Carcinoma, Clinical Stage III Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Merkel Cell Carcinoma AJCC v8
About this trial
This is an interventional treatment trial for Advanced Merkel Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients must have pathologically (histologically or cytologically) proven diagnosis of MCC by local pathology review
- Have measurable disease based on RECIST 1.1 including at least two cancerous deposits; at least one deposit must be RECIST measurable while at least one deposit must meet criteria for SBRT; non-radiated tumor will be identified prior to randomization on the protocol
Patients must have advanced or metastatic MCC defined as evidence of distant metastasis(es) on imaging
- Patients with locoregionally confined disease are not eligible
- No prior immunotherapy for advanced/metastatic MCC
- Patients with known or suspected central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded; however, subjects with controlled brain metastases will be allowed to enroll; controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms
Patients having received palliative radiotherapy for extracranial metastasis(es) are eligible as long as there are 2 cancerous deposits that have not received prior radiation therapy (RT) and they meet the following criteria
- No prior radiation therapy (> 5 Gy) to the metastasis intended to be treated with SBRT
No history of the following:
- Autoimmunity requiring systemic immunosuppression within 2 years
Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following:
- CD4 counts >= 350 mm^3
- Serum HIV viral load of < 25,000 IU/ml
- No other active malignancy that the investigator determines would interfere with the treatment and safety analysis
- Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; therefore, for women of childbearing potential only, a negative (if your test schedule specifically indicates a urine or serum pregnancy test, add that information at this point) pregnancy test done =< 28 days prior to registration is required
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 9.0 g/dl
- Total bilirubin =< 2.0 mg/dl
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x upper limit of normal (ULN)
- Systolic blood pressure (BP) =< 150 mg HG
- Diastolic BP =< 90 mg HG
- Albumin > 3 mg/dl
- Blood urea nitrogen (BUN) =< 30 mg/dl
- Creatinine =< 1.7 mg/dl
- The following imaging workup to document metastases within 45 days prior to study registration are required: CT scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body (at least skull base to midthigh) positron emission tomography (PET)/CT
Sites / Locations
- Anchorage Associates in Radiation Medicine
- 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
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- PCR Oncology
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Porter Adventist Hospital
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Longmont United Hospital
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers-Thornton
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- Mount Sinai Comprehensive Cancer Center at Aventura
- Holy Cross Hospital
- Mount Sinai Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- 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
- Rush - Copley Medical Center
- Northwestern University
- Rush University Medical Center
- University of Chicago Comprehensive Cancer Center
- Carle on Vermilion
- Carle Physician Group-Effingham
- Northwestern Medicine Lake Forest Hospital
- Carle Physician Group-Mattoon/Charleston
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- University of Chicago Medicine-Orland Park
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Indiana University/Melvin and Bren Simon Cancer Center
- Sidney and Lois Eskenazi Hospital
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Menorah Medical Center
- University of Kansas Cancer Center-Overland Park
- Saint Luke's South Hospital
- University of Kansas Hospital-Westwood Cancer Center
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Jewish Hospital
- UofL Health Medical Center Northeast
- Ochsner Health Center-Summa
- Medical Center of Baton Rouge
- Ochsner High Grove
- Ochsner Medical Center Jefferson
- Bronson Battle Creek
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton Shores
- Spectrum Health Reed City Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Munson Medical Center
- Metro Health Hospital
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview Southdale Hospital
- Unity Hospital
- 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
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Siteman Cancer Center at West County Hospital
- Centerpoint Medical Center LLC
- Freeman Health System
- Saint Luke's Hospital of Kansas City
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Community Medical Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Comprehensive Cancer Centers of Nevada - Henderson
- OptumCare Cancer Care at Seven Hills
- OptumCare Cancer Care at Charleston
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- Radiation Oncology Centers of Nevada Southeast
- Comprehensive Cancer Centers of Nevada - Northwest
- OptumCare Cancer Care at MountainView
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Comprehensive Cancer Centers of Nevada-Summerlin
- Comprehensive Cancer Centers of Nevada
- OptumCare Cancer Care at Fort Apache
- Comprehensive Cancer Centers of Nevada - Central Valley
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- Hackensack University Medical Center
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Duke University Medical Center
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Strecker Cancer Center-Belpre
- Adena Regional Medical Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- MetroHealth Medical Center
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Dublin Methodist Hospital
- Fairfield Medical Center
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Southern Ohio Medical Center
- Saint Ann's Hospital
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Bay Area Hospital
- Providence Newberg Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Geisinger Medical Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- University of Pennsylvania/Abramson Cancer Center
- Geisinger Wyoming Valley/Henry Cancer Center
- Medical University of South Carolina
- Gibbs Cancer Center-Gaffney
- Gibbs Cancer Center-Pelham
- Spartanburg Medical Center
- MGC Hematology Oncology-Union
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Memorial Hospital
- Saint Joseph Regional Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- Providence Regional Cancer System-Aberdeen
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Providence Regional Cancer Partnership
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-Lacey
- PeaceHealth Saint John Medical Center
- Valley Medical Center
- Swedish Medical Center-Ballard Campus
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- PeaceHealth United General Medical Center
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- Marshfield Medical Center-EC Cancer Center
- Marshfield Medical Center-Marshfield
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Marshfield Medical Center-Rice Lake
- Marshfield Medical Center-River Region at Stevens Point
- Marshfield Clinic-Wausau Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Billings Clinic-Cody
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Group I (pembrolizumab)
Group II (pembrolizumab, SBRT)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.