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
A
Ahmad Al-Hader, MD
Primary Investigator
Recruiting
18-100 years
All
Phase
N/A
2 Locations
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Merkel Cell Carcinoma
-
Age: Between 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.
Additional Information:Participants will not be paid for their participation.
Updated on
01 Aug 2024.
Study ID: 1808895146 (A091605)
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