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

Start date

Dec 12, 2018

Status verified

May 2026

Primary completion

Aug 12, 2025

Completion

Jun 30, 2026

Study Design

Enrollment

329 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Olaparib
  Participants with HRRm or HRD-positive advanced cancer will receive oral olaparib, 300 mg twice daily (BID).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 53 months ]

Locations (24)

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