NCT02743819

Pembrolizumab and Ipilimumab After Prior Immunotherapy for Melanoma

Phase II Study of Pembrolizumab and Ipilimumab Following Initial Anti-PD1/L1 Antibody

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab given every 3 weeks (200 mg) by IV infusion.
DRUG	Ipilimumab	Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.

Timeline

• Start date: 2016-06-28
• Primary completion: 2022-06-01
• Completion: 2026-06-01
• First posted: 2016-04-19
• Last updated: 2025-06-10
• Results posted: 2022-04-21

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study