Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)

Conditions

• Advanced Solid Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olaparib — DRUG
  Olaparib 300 mg administered BID as two, 150 mg oral tablets.

Study Details

This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD).

Key Dates

First listed

Nov 15, 2018

Start date

Dec 12, 2018

Status verified

Jun 2026

Primary completion

Aug 12, 2025

Completion

Jun 30, 2027

Study Design

Enrollment

329 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: BRCA1/2
  Per protocol, participants with tumors that harbor known or suspected deleterious mutations in breast cancer susceptibility gene 1 or gene 2 (BRCA1/2) based on the Lynparza homologous recombination repair-homologous recombination deficiency (HRR-HRD) Assay, excluding breast and ovarian cancers, were considered BRCA1/2 mutated and enrolled into Cohort 1: BRCA1/2. Participants with known or suspected deleterious mutations in BRCA1/BRCA2 were enrolled into Cohort 1 whether or not they were homologous recombination repair mutated (HRRm) positive for the other protocol specified genes in the Lynparza HRR-HRD Assay, or whether they had Loss of Heterozygosity (LOH) protocol specified score of ≥16. Participants in Cohort 1: BRCA1/2 received oral olaparib,300 mg twice daily (BID) continuously until documented disease progression or discontinuation criteria were met.
• Experimental: Cohort 2: HRD+, HRR Non-mutated
  Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2, or any of the protocol specified genes in the Lynparza HRR-HRD Assay (BRCA1/2 Non-mutated/HRR Non-mutated) but had a LOH score greater than or equal to the protocol specified cutoff of 16, were considered homologous recombination deficiency positive (HRD+) and enrolled into Cohort 2: HRD+(BRCA1/2 non-mutated/HRR Non-mutated). Participants in Cohort 2: HRD+ (BRCA1/2 Non-mutated/HRR Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
• Experimental: Cohort 2: HRRm, BRCA Non-mutated
  Per protocol, participants with tumors that do NOT have any known or suspected deleterious mutations in BRCA1/2 but have known or suspected deleterious mutations in any of the protocol specified genes in the Lynparza HRR-HRD Assay were considered homologous recombination repair mutated \[HRRm\] and were enrolled into Cohort 2: HRRm (BRCA1/2 Non-mutated). Participants in Cohort 2: HRRm (BRCA1/2 Non-mutated) received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.
• Experimental: Cohort 3: sBRCAm Breast Cancer
  Per protocol, participants with breast cancer tumors that harbor known or suspected deleterious somatic mutations in BRCA1/2 and do not harbor a germline BRCA1/2 mutation were enrolled into Cohort 3: somatic BRCA1/2 mutations (sBRCAm). Participants in Cohort3: sBRCAm Breast Cancer received oral olaparib, 300 mg BID continuously until documented disease progression or discontinuation criteria were met.

Primary Outcome Measure

All Cohorts: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 [ Time Frame: Up to approximately 78 months ]

Locations (24)

Find similar trials in Tucson, AZ