A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- Incyte Corporation
- Study ID
- NCT03599713
- Phase
- PHASE2
- Status
- Completed
Conditions
- Metastatic Merkel Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Retifanlimab — DRUGINCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Study Details
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).
Key Dates
- Start date
- Feb 25, 2019
- Status verified
- Aug 2025
- Primary completion
- Jan 21, 2022
- Completion
- Jun 28, 2024
Study Design
- Enrollment
- 107 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Retifanlimab: Chemotherapy: Naïve
- Experimental: Retifanlimab: Chemotherapy: Refractory
Primary Outcome Measure
Objective Response Rate (ORR) [ Time Frame: up to 26.8 months ]
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford Cancer Institute | Palo Alto | California | 94304 | - |
| University of California San Francisco Comprehensive Cancer Center | San Francisco | California | 94143 | - |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | - |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | - |
| Rush University | Chicago | Illinois | 60612 | - |
| Norton Cancer Institute | Louisville | Kentucky | 40241 | - |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | - |
| John Theurer Cancer Center, Hackensack University Medical Center | Hackensack | New Jersey | 07601 | - |
| Rutgers Cancer Institute of Nj | New Brunswick | New Jersey | 08901 | - |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | - |
| University of Rochester Medical Center | Rochester | New York | 14642 | - |
| The Christ Hospital | Cincinnati | Ohio | 45219 | - |
| Upmc Cancercenter | Pittsburgh | Pennsylvania | 15232 | - |
| Inova Fairfax Hospital | Fairfax | Virginia | 22031 | - |
| University of Washington - Seattle Cancer Care Alliance | Seattle | Washington | 98109 | - |
| West Virginia University Hospitals Inc | Morgantown | West Virginia | 26506 | - |
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