Phase II Study of Olaparib and Pembrolizumab in Advanced Melanoma With Homologous Recombination (HR) Mutation

Part of paid clinical trials in San Francisco, California.

Sponsor
California Pacific Medical Center Research Institute
Study ID
NCT04633902
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib 300 mg BID daily
  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg IV eveyr 3 weeks (for up to 2 years)

Study Details

This open-label phase II trial studies how well olaparib in combination with pembrolizumab works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and potentially augment an anti-tumor immune response to pembrolizumab. The trial is designed to assess the efficacy and safety of olaparib in combination with pembrolizumab in patients with HR mutation/ alteration whose disease progressed on prior immunotherapy and/or BRAF-targeting therapy

Key Dates

Start date
Mar 3, 2021
Status verified
Dec 2022
Primary completion
Jun 30, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib + Pembrolizumab
    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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
California Pacific Medical Center Research InstituteSan FranciscoCalifornia94115-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Debbie Stroughter
[email protected]
713-792-7734
Sapna Patel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
California Pacific Medical Center Research Institute· San Francisco, CAThe University of Texas MD Anderson Cancer Center· Houston, TX

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