Pembrolizumab and Ipilimumab After Prior Immunotherapy for Melanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Melanoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary Objective: To determine the irRECIST* response rate of pembrolizumab with ipilimumab following initial progression or stable disease to anti-PD1/L1 antibody (or combination not containing anti-CTLA4) in subjects with advanced melanoma. Secondary Objective To summarize the progression-free su...
Primary Objective: To determine the irRECIST* response rate of pembrolizumab with ipilimumab following initial progression or stable disease to anti-PD1/L1 antibody (or combination not containing anti-CTLA4) in subjects with advanced melanoma. Secondary Objective To summarize the progression-free survival (RECIST v1.1 and irRC) of the combination following prior treatment with anti-PD1/L1 antibody. To assess the safety of the combination following prior treatment with anti-PD1/L1 antibody. Exploratory Objective: To evaluate changes in the tumor microenvironment and other biospecimens before and after adding ipilimumab to pembrolizumab.
Tracking Information
- NCT #
- NCT02743819
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Thomas Gajewski, M.D. University of Chicago
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