MedTrace Logo

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

NCT04633902 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-12-06

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Olaparib

Olaparib 300 mg BID daily

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV eveyr 3 weeks (for up to 2 years)

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • California Pacific Medical Center Research Institute

    lead OTHER

Principal Investigators

  • Kevin B Kim, MD · California Pacific Medical Center Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2023-06-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04633902 on ClinicalTrials.gov