Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma

Completed · Phase 2

Conditions studied: Advanced Merkel Cell Carcinoma, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Metastatic Merkel Cell Carcinoma, Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIA Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIB Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8

In brief

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.

Key facts

Study ID: NCT03304639
Run by: National Cancer Institute (NCI)
People needed: 9
Starts: 2018-06-12
Expected to finish: 2026-02-19
Last updated by the study team: 2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
Alaska Women's Cancer Care — Anchorage, Alaska, United States
Anchorage Oncology Centre — Anchorage, Alaska, United States
Katmai Oncology Group — Anchorage, Alaska, United States
Providence Alaska Medical Center — Anchorage, Alaska, United States
Banner University Medical Center - Tucson — Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
PCR Oncology — Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose — Colorado Springs, Colorado, United States
AdventHealth Porter — Denver, Colorado, United States
Saint Anthony Hospital — Lakewood, Colorado, United States
AdventHealth Littleton — Littleton, Colorado, United States
Longmont United Hospital — Longmont, Colorado, United States
AdventHealth Parker — Parker, Colorado, United States
Saint Mary Corwin Medical Center — Pueblo, Colorado, United States
Rocky Mountain Cancer Centers-Thornton — Thornton, Colorado, United States
Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut, United States
Yale University — New Haven, Connecticut, United States
Mount Sinai Comprehensive Cancer Center at Aventura — Aventura, Florida, United States
Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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