Olaparib + Pembrolizumab for Melanoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byKevin B Kim, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: California Pacific Medical Center Research Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a combination of olaparib and pembrolizumab in patients with advanced melanoma who have specific genetic mutations. Olaparib blocks cancer cell growth by interfering with DNA repair, while pembrolizumab boosts the immune system to fight cancer. The goal is to see if this combination works better for patients who haven't responded to other treatments.

Eligibility Criteria

This trial is for adults with advanced melanoma that can't be removed by surgery or has spread, and have specific gene changes called HR mutations. They must have tried immunotherapy and, if they have a BRAF mutation, also BRAF inhibitors without success or couldn't tolerate them. Participants need to be fairly healthy overall and not on high-dose steroids.

Inclusion Criteria

My cancer has a specific genetic mutation.

I have had only one chemotherapy treatment but may have had multiple immunotherapy or targeted therapy treatments.

My melanoma cannot be removed by surgery and is in stage III or IV.

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Exclusion Criteria

I have had lung inflammation from specific cancer treatment that needed steroids.

I have had an organ, bone marrow, or cord blood transplant for cancer.

My brain metastases are stable, and I haven't needed steroids for 14 days.

See 5 more

Treatment Details

Interventions

Olaparib (PARP Inhibitor)
Pembrolizumab (Checkpoint Inhibitor)

Trial OverviewThe study tests the combination of Olaparib, which blocks enzymes helping tumor growth, with Pembrolizumab, an immune system booster against cancer. It's for patients whose melanoma worsened after previous treatments. The goal is to see how effective and safe this drug combo is in these cases.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Olaparib + PembrolizumabExperimental Treatment2 Interventions

This arm will enroll patients who has advanced melanoma with a genetic HR mutation/ alteration including mutation/ deletion in ARID1A/B, ARID2, ATM, ATR, BARD1, BRCA1/2, BAP1, BRIP1, CHEK2, FANCA, FANCD2, MRN11A, PALB2, RAD50, RAD51, RAD54B.

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

🇪🇺 Approved in European Union as Lynparza for: