Last updated on October 2018

Pembrolizumab and Ipilimumab After Prior Immunotherapy for Melanoma

Brief description of study

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.

Detailed Study 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

  1. To summarize the progression-free survival (RECIST v1.1 and irRC) of the combination following prior treatment with anti-PD1/L1 antibody.
  2. 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.

Clinical Study Identifier: NCT02743819

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Mount Sinai Medical Center of Florida

Miami Beach, FL United States
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