A Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma

Investigating the Effectiveness of an Investigational Medication with or without Radiation Therapy in Advanced Merkel Cell Cancer

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

The purpose of this study is 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.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced Merkel Cell Carcinoma,Merkel Cell Carcinoma,carcinoma,cancer,oncology
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • 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.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1808895146 (A091605)

This study investigates the effectiveness of an investigational medication, with or without stereotactic body radiation therapy, in treating patients with Merkel cell cancer that has spread to other parts of the body. Merkel cell cancer is a rare type of skin cancer that grows quickly and can spread to other areas. The purpose of this study is to compare how well patients do without their disease getting worse when they receive both the investigational medication and radiation therapy versus the medication alone.

Participants in this study will receive either the investigational medication alone or in combination with stereotactic body radiation therapy. Stereotactic body radiation therapy is a method of delivering high doses of radiation to a specific area of the body. The investigational medication is a substance being tested to see if it can treat the cancer. The study will monitor the participants' health and any changes in their cancer.

  • Who can participate: Adults with advanced or metastatic Merkel cell carcinoma with evidence of distant metastasis are eligible. Patients should not have received prior immunotherapy for their advanced cancer. Those with controlled brain metastases are allowed but not if the brain is the only site affected.
  • Study details: Participants will either receive the investigational medication alone or in combination with stereotactic body radiation therapy. The investigational medication is being tested to see if it can treat cancer. Radiation therapy involves targeting cancer cells with high-energy rays.

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