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Pembrolizumab with or without Stereotactic Body Radiation Therapy in Treating Patients with Advanced or Metastatic Merkel Cell Cancer

Trial Status: Closed to Accrual

This randomized phase II trial studies how well pembrolizumab with or without stereotactic body radiation therapy works in treating patients with Merkel cell cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pembrolizumab with stereotactic body radiation therapy may work better in treating patients with Merkel cell cancer.

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

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Oncology and Hematology LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Women's Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Associates in Radiation Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Providence Alaska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871

Arizona

Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
University of Arizona Cancer Center-North Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-327-2873

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-378-9373
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

California

Arroyo Grande
PCR Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 818-847-4793

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Penrose
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Denver
Porter Adventist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Lakewood
Saint Anthony Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Littleton
Littleton Adventist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Longmont
Longmont United Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Parker
Parker Adventist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Pueblo
Saint Mary Corwin Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Thornton
Rocky Mountain Cancer Centers-Thornton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Connecticut

New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 203-785-5702

Florida

Aventura
Mount Sinai Comprehensive Cancer Center at Aventura
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-674-2625
Fort Lauderdale
Holy Cross Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 954-267-7750
Miami Beach
Mount Sinai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-674-2625

Georgia

Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 912-819-5704

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-2774
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-8059
Meridian
Idaho Urologic Institute-Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute - Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-8059
Nampa
Saint Alphonsus Medical Center-Nampa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute - Nampa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-8059
Post Falls
Kootenai Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 208-381-8059

Illinois

Aurora
Rush - Copley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212
Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-695-1301
Rush University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-942-5498
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-8222
Danville
Carle on Vermilion
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Effingham
Carle Physician Group-Effingham
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-242-4600
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-8222
Orland Park
University of Chicago Medicine-Orland Park
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-8222
Urbana
Carle Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Yorkville
Rush-Copley Healthcare Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-278-5632
Sidney and Lois Eskenazi Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-278-5632

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Cancer Center-West Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Creston
Greater Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Des Moines
Broadlawns Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Medical Center - Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
West Des Moines
Mercy Medical Center-West Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Methodist West Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-343-1000

Kansas

Garden City
Central Care Cancer Center - Garden City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Great Bend
Central Care Cancer Center - Great Bend
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-945-7552
Lawrence
Lawrence Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Lenexa
Kansas Institute of Medicine Cancer and Blood Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Minimally Invasive Surgery Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Overland Park
Menorah Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Saint Luke's South Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
University of Kansas Cancer Center-Overland Park
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-945-7552
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-945-7552
Wichita
Ascension Via Christi Hospitals Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-362-0070
Cancer Center of Kansas - Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374

Kentucky

Lexington
Saint Joseph Hospital East
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Saint Joseph Radiation Oncology Resource Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Louisville
Jewish Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Jewish Hospital Medical Center Northeast
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Louisiana

Baton Rouge
Medical Center of Baton Rouge
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 225-761-5346
Ochsner Health Center-Summa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 225-761-5346
Ochsner High Grove
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 504-703-8712
New Orleans
Ochsner Medical Center Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 504-703-8712

Michigan

Battle Creek
Bronson Battle Creek
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Mercy Health Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Kalamazoo
Borgess Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Bronson Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Muskegon
Mercy Health Mercy Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Niles
Lakeland Hospital Niles
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Reed City
Spectrum Health Reed City Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Traverse City
Munson Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Wyoming
Metro Health Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-333-5000
Burnsville
Fairview Ridges Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Edina
Fairview Southdale Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Monticello
Monticello Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Shakopee
Saint Francis Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Waconia
Ridgeview Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-7058
Bolivar
Central Care Cancer Center - Bolivar
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Independence
Centerpoint Medical Center LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Joplin
Freeman Health System
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-347-4030
Kansas City
Research Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Saint Luke's Hospital of Kansas City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Lee's Summit
Saint Luke's East - Lee's Summit
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Rolla
Delbert Day Cancer Institute at PCRMC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Siteman Cancer Center-South County
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Springfield
CoxHealth South Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520

Montana

Anaconda
Community Hospital of Anaconda
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Bozeman
Bozeman Deaconess Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Helena
Saint Peter's Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Nebraska

Grand Island
CHI Health Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Kearney
CHI Health Good Samaritan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Omaha
Alegent Health Bergan Mercy Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Immanuel Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Lakeside Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Creighton University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Nevada

Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Seven Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas
21st Century Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Fort Apache
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at MountainView
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Oakey
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Southeast
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Radiation Oncology Associates
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Renown Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013

New Jersey

Hackensack
Hackensack University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 201-996-2879

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: IN_REVIEW
Contact: Site Public Contact
Phone: 212-305-6361

North Carolina

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-275-3853
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Roger Maris Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Belpre
Strecker Cancer Center-Belpre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-523-3977
Chillicothe
Adena Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-779-7585
Cincinnati
Bethesda North Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Good Samaritan Hospital - Cincinnati
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Cleveland
MetroHealth Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 216-778-8526
Columbus
Columbus Oncology and Hematology Associates Inc
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Doctors Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-3275
Grant Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-4475
Mount Carmel East Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Mount Carmel Health Center West
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-234-5433
Riverside Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Delaware
Delaware Health Center-Grady Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-615-0227
Delaware Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Grady Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-615-2403
Dublin
Dublin Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-752-9119
Lancaster
Fairfield Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-687-8863
Mansfield
OhioHealth Mansfield Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-526-8018
Marietta
Marietta Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-523-3977
Marion
OhioHealth Marion General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Mount Vernon
Knox Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-393-9000
Newark
Licking Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-348-4000
Newark Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Portsmouth
Southern Ohio Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Westerville
Saint Ann's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-234-5433
Zanesville
Genesis Healthcare System Cancer Care Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-454-5232

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Bend
Saint Charles Health System
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Portland
Providence Portland Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614

Pennsylvania

Danville
Geisinger Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-374-8555
Lewistown
Lewistown Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-242-7703
Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-474-9892
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 843-792-9321
Gaffney
Gibbs Cancer Center-Gaffney
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-560-6104
Greer
Gibbs Cancer Center-Pelham
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-560-6104
Spartanburg
Spartanburg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-560-6104
Union
MGC Hematology Oncology-Union
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-560-6104

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Chattanooga
Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 804-628-1914

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Bellevue
Overlake Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 425-688-5407
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-715-4133
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Harrison Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Burien
Highline Medical Center-Main Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Centralia
Providence Regional Cancer System-Centralia
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Everett
Providence Regional Cancer Partnership
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 425-261-3529
Issaquah
Swedish Cancer Institute-Issaquah
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Kennewick
Kadlec Clinic Hematology and Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 509-783-4637
Lacey
Providence Regional Cancer System-Lacey
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-412-8958
Longview
PeaceHealth Saint John Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-2016
Renton
Valley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 425-228-3440
Seattle
Kaiser Permanente Washington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Ballard Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-First Hill
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Sedro-Woolley
PeaceHealth United General Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-788-8240
Tacoma
Northwest Medical Specialties PLLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Vancouver
PeaceHealth Southwest Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 509-897-5993

Wisconsin

Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Marshfield
Marshfield Medical Center-Marshfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Minocqua
Marshfield Clinic-Minocqua Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
New Richmond
Cancer Center of Western Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Rice Lake
Marshfield Medical Center-Rice Lake
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Stevens Point
Marshfield Clinic Stevens Point Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Wausau
Marshfield Clinic-Wausau Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Weston
Diagnostic and Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-799-3989
Marshfield Clinic - Weston Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581

Wyoming

Cody
Billings Clinic-Cody
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663

PRIMARY OBJECTIVE:

I. To describe the progression-free survival (PFS) of stereotactic body radiation therapy (SBRT) + pembrolizumab (MK-3475) compared to MK-3475 alone in advanced/metastatic Merkel cell carcinoma (MCC) patients.

SECONDARY OBJECTIVES:

I. To describe the PFS of SBRT + MK-3475 compared to MK-3475 alone across Response Evaluation Criteria in Solid Tumors (RECIST) measurable (including both radiated and non-radiated) cancer deposits.

II. To describe the overall response rate of SBRT + MK-3475 compared to MK-3475 alone in both radiated and in non-radiated deposit(s).

III. To determine the PFS at 6 months of SBRT + MK-3475 compared to MK-3475 alone across all cancerous deposits by RECIST.

IV. To determine the rate of grade > 3-4 adverse events, by organ system, by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

V. To determine the local control of SBRT treated tumors.

VI. To calculate delivered radiation dose using cone-beam computed tomography (CT) images collected on the radiation treatment table in the final treatment position.

CORRELATIVE SCIENCE OBJECTIVES:

I. To test the utility of CT-based radiomics to predict radiation-induced pneumonitis and true delivered dose of SBRT based on cone beam collected imaging and diagnostic scans.

II. Biobanking for future correlative science projects.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive pembrolizumab intravenously (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.

GROUP II: 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.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Jason John Luke

  • Primary ID A091605
  • Secondary IDs NCI-2017-01817
  • Clinicaltrials.gov ID NCT03304639