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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Advanced Merkel Cell Carcinoma

Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 ...

Detailed Description

PRIMARY OBJECTIVE: I. To describe the progression-free survival (PFS) of stereotactic body radiation therapy (SBRT) + pembrolizumab (MK-3475) compared to pembrolizumab (MK-3475) alone in advanced/met...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 12 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 19 2026

    Estimated Enrollment :

    9 Patients enrolled

    Trial Details

    Trial ID

    NCT03304639

    Start Date

    June 12 2018

    End Date

    September 19 2026

    Last Update

    November 12 2025

    Active Locations (255)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 64 (255 locations)

    1

    Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, United States, 98508

    2

    Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, United States, 99508

    3

    Alaska Oncology and Hematology LLC

    Anchorage, Alaska, United States, 99508

    4

    Alaska Women's Cancer Care

    Anchorage, Alaska, United States, 99508