Pembrolizumab Compared to Standard of Care Observation in Treating Patients with Completely Resected Stage I-III Merkel Cell Cancer, STAMP Study
Inclusion Criteria
- 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).
- Women must not be pregnant or breast-feeding due to the unknown effects of the study drug in this setting. All women of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is 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, on Arm A MK-3475 (pembrolizumab must use accepted and effective method(s) of contraception or abstain from sex from 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.
- 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 not eligible. * The primary tumor must have grossly negative margins. (Microscopically positive margins are allowed). * Cancers of unknown primary that have regional disease only can be included. * 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 registration.
- All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 8 weeks prior to registration.
- 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 registration. Patients actively undergoing radiation therapy or having completed adjuvant radiation therapy within 6 weeks of registration are eligible, as long as resection date is within 16 weeks of registration.
- 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 upper limit of normal (ULN) (within 4 weeks prior to randomization).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (within 4 weeks prior to randomization).
- Total bilirubin =< 2.0 x 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.
- 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.
- 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.
Alaska
Anchorage
Arizona
Kingman
Tucson
Arkansas
Ft. Smith
California
Arroyo Grande
Auburn
Berkeley
Burbank
Burlingame
Cameron Park
Castro Valley
Davis
Fremont
Los Angeles
Modesto
Mountain View
Newport Beach
Novato
Orange
Palo Alto
Pasadena
Roseville
Sacramento
San Francisco
Santa Cruz
Santa Rosa
Sunnyvale
Vacaville
Vallejo
Connecticut
New Haven
District of Columbia
Washington
Florida
Coral Gables
Deerfield Beach
Fort Lauderdale
Fort Myers
Miami
Orlando
Plantation
Tampa
Georgia
Atlanta
Savannah
Idaho
Boise
Caldwell
Coeur D'Alene
Emmett
Fruitland
Meridian
Nampa
Post Falls
Sandpoint
Twin Falls
Illinois
Aurora
Bloomington
Canton
Carbondale
Carterville
Carthage
Centralia
Chicago
Danville
Decatur
Dixon
Effingham
Eureka
Galesburg
Kewanee
Lake Forest
Macomb
Mattoon
Mount Vernon
O'Fallon
Ottawa
Pekin
Peoria
Peru
Princeton
Springfield
Swansea
Urbana
Yorkville
Indiana
Indianapolis
South Bend
Iowa
Cedar Rapids
Des Moines
Fort Dodge
West Des Moines
Kansas
Coffeyville
Hays
Kansas City
Lawrence
Olathe
Overland Park
Pittsburg
Salina
Topeka
Westwood
Maryland
Baltimore
Massachusetts
Boston
Springfield
Michigan
Ann Arbor
Brighton
Canton
Caro
Chelsea
Clarkston
Detroit
East China
Flint
Grosse Pointe Woods
Lansing
Livonia
Macomb Township
Marlette
Pontiac
Port Huron
Rochester Hills
Saginaw
Sterling Heights
Tawas City
Warren
West Branch
Ypsilanti
Minnesota
Bemidji
Burnsville
Cambridge
Coon Rapids
Duluth
Edina
Fridley
Maple Grove
Maplewood
Minneapolis
Monticello
New Ulm
Princeton
Robbinsdale
Rochester
Saint Louis Park
Saint Paul
Stillwater
Thief River Falls
Waconia
Willmar
Woodbury
Worthington
Wyoming
Missouri
Ballwin
Bonne Terre
Branson
Cape Girardeau
Creve Coeur
Farmington
Jefferson City
Joplin
Kansas City
North Kansas City
Rolla
Saint Joseph
Saint Louis
Saint Peters
Sainte Genevieve
Springfield
Sullivan
Sunset Hills
Washington
Montana
Anaconda
Billings
Bozeman
Great Falls
Helena
Kalispell
Missoula
Nebraska
Omaha
Nevada
Carson City
Henderson
Las Vegas
Pahrump
Reno
New Jersey
Hackensack
Livingston
Morristown
New Brunswick
Summit
New York
New York
Rochester
Stony Brook
North Carolina
Durham
Greenville
Hendersonville
Winston-Salem
North Dakota
Bismarck
Fargo
Ohio
Beachwood
Chardon
Cincinnati
Cleveland
Mentor
Middleburg Heights
Parma
Ravenna
Sandusky
Strongsville
Wadsworth
West Chester
Westlake
Wooster
Oklahoma
Lawton
Oklahoma City
Tulsa
Oregon
Baker City
Bend
Clackamas
Coos Bay
Newberg
Ontario
Portland
Redmond
Pennsylvania
Allentown
Bethlehem
Danville
East Stroudsburg
Hazleton
Hershey
Lewisburg
Lewistown
Philadelphia
Pittsburgh
Pottsville
Scranton
Selinsgrove
State College
Wilkes-Barre
South Carolina
Charleston
Gaffney
Greer
Hilton Head Island
Spartanburg
Union
South Dakota
Sioux Falls
Tennessee
Knoxville
Texas
Dallas
Utah
Salt Lake City
Virginia
Charlottesville
Richmond
Washington
Aberdeen
Bellevue
Bellingham
Centralia
Edmonds
Everett
Issaquah
Kennewick
Lacey
Longview
Renton
Seattle
Sedro-Woolley
Shelton
Vancouver
Walla Walla
Yelm
Wisconsin
Appleton
Eau Claire
Green Bay
Marshfield
Menomonee Falls
Milwaukee
Minocqua
New Richmond
Rice Lake
Stevens Point
West Bend
Weston
Wyoming
Cody
Sheridan
PRIMARY OBJECTIVE:
I. To compare overall survival (OS) and recurrence free survival (RFS) as co-primary endpoints across the two arms.
SECONDARY OBJECTIVES:
I. To evaluate adverse events.
II. To evaluate distant metastasis free survival (DMFS).
III. To evaluate the impact of radiation on clinical outcomes (OS, RFS, DMFS).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive pembrolizumab intravenously (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.
ARM B: 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.
After completion of study treatment, patients are followed up every 6 months for 5 years.
Trial Phase Phase III
Trial Type Treatment
Lead Organization
ECOG-ACRIN Cancer Research Group
Principal Investigator
Brian R. Gastman
- Primary ID EA6174
- Secondary IDs NCI-2018-02217
- Clinicaltrials.gov ID NCT03712605