Pembrolizumab and Ipilimumab After Prior Immunotherapy for Melanoma
Part of paid clinical trials in Mobile, Alabama.
- Sponsor
- University of Chicago
- Study ID
- NCT02743819
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pembrolizumab — DRUGPembrolizumab given every 3 weeks (200 mg) by IV infusion.
- Ipilimumab — DRUGIpilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
Study Details
Phase II study evaluating the benefit of the combination of anti-PD1 (pembrolizumab) and anti-CTLA4 (ipilimumab) antibodies in advanced melanoma. The study will determine the response rate of the combination and evaluate other clinical parameters such as progression-free survival and safety of the combination following anti-PD1/L1 antibody. The study will also provide the opportunity to investigate blood or tumor based factors that may predict response to anti-PD1 antibody in combination with anti-CTLA4.
Key Dates
- Start date
- Jun 28, 2016
- Status verified
- Jun 2025
- Primary completion
- Jun 1, 2022
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 70 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TreatmentTreatment with the combination of pembrolizumab and ipilimumab.
Primary Outcome Measure
Overall Response Rate (OR) Per irRECIST [ Time Frame: 16 weeks ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36604 | - |
| Mount Sinai Medical Center of Florida | Miami Beach | Florida | 33140 | - |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | - |
| University of Chicago | Chicago | Illinois | 60637 | - |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | - |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | - |
| Oncology Specialists S.C. | Park Ridge | Illinois | 60068 | - |
| Illinois Cancer Care | Peoria | Illinois | 61615 | - |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | 46804 | - |
| Virginia Commonwealth University/ Massey Cancer Center | Richmond | Virginia | 23298 | - |
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