Pembrolizumab + Ipilimumab for Melanoma

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen by Thomas Gajewski, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with advanced melanoma who've seen their cancer progress or remain stable after at least 24 weeks on anti-PD1/L1 therapy, or within 6 months of adjuvant anti-PD1. They must be in good health otherwise, not pregnant, willing to use birth control, and have no history of severe allergies to the drugs being tested or certain other medical conditions.

Inclusion Criteria

I am at least 18 years old.

Be willing and able to provide written informed consent for the trial

I have taken a pregnancy test in the last 72 hours and it was negative.

Exclusion Criteria

I have a history of active tuberculosis.

I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

I do not have eye melanoma.

Participant Groups

The study tests a combination of two immunotherapy drugs: Pembrolizumab (anti-PD1) and Ipilimumab (anti-CTLA4), following prior treatment with an anti-PD1/L1 antibody. It aims to see how well this combo works against melanoma by measuring tumor response and tracking how long patients live without their disease getting worse.

Group I: Treatment Experimental Treatment 2 Interventions

Treatment with the combination of pembrolizumab and ipilimumab.

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

🇪🇺 Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of South Alabama Mobile, AL

H. Lee Moffitt Cancer Center and Research Institute Tampa, FL

Mount Sinai Medical Center of Florida Miami Beach, FL

University of Chicago Chicago, IL

More Trial Locations

Who Is Running the Clinical Trial?

University of Chicago Lead Sponsor

References