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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Olaparib: Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Study summary
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).
Eligibility
Primary outcome measure(s)
- Cohorts 1, 2, 3: 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 — Up to approximately 78 months
ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the BICR per modified RECIST 1.1. For participants with prostate cancer, response was assessed based on PCWG-modified RECIST 1.1 criteria (CR: soft tissue CR with no evidence of disease \[NED\] on bone scan; PR: soft tissue PR with non-progressive disease, non-evaluable \[NE\], or NED on bone scan, or soft tissue CR with non-progressive disease, or NE bone scan). Per protocol, RECIST 1.1 was modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by BICR is presented.
Trial sites (130)
| Facility | City | Region | Status |
|---|---|---|---|
| The University of Arizona Cancer Center - North Campus ( Site 0011) | Tucson | Arizona | |
| St Joseph Heritage Healthcare-Oncology ( Site 0056) | Fullerton | California | |
| Cedars Sinai Medical Center ( Site 0002) | Los Angeles | California | |
| UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007) | San Francisco | California | |
| Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092) | Aurora | Colorado | |
| Winship Cancer Institute of Emory University ( Site 0025) | Atlanta | Georgia | |
| Augusta University ( Site 0028) | Augusta | Georgia | |
| Markey Cancer Center ( Site 0018) | Lexington | Kentucky | |
| University of Maryland ( Site 0050) | Baltimore | Maryland | |
| Weinberg Cancer Institute at Franklin Square ( Site 0054) | Baltimore | Maryland | |
| University of Massachusetts ( Site 0017) | Worcester | Massachusetts | |
| Henry Ford Health System ( Site 0060) | Detroit | Michigan | |
| Cancer Partners of Nebraska ( Site 0051) | Lincoln | Nebraska | |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116) | Middletown | New Jersey | |
| Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126) | Harrison | New York | |
| VA New York Harbor Healthcare System Manhattan ( Site 0094) | New York | New York | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057) | New York | New York | |
| Memorial Sloan Kettering Cancer Center ( Site 0026) | New York | New York | |
| Southwestern Regional Medical Center, Inc. ( Site 0079) | Tulsa | Oklahoma | |
| Eastern Regional Medical Center, Inc. ( Site 0077) | Philadelphia | Pennsylvania | |
| Sanford Hematology Oncology-Sioux Falls SD ( Site 0012) | Sioux Falls | South Dakota | |
| Intermountain Healthcare ( Site 0043) | St. George | Utah | |
| Virginia Mason Medical Center ( Site 0052) | Seattle | Washington | |
| Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093) | Seattle | Washington | |
| Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703) | Berazategui | Buenos Aires | |
| Hospital Britanico de Buenos Aires ( Site 2704) | Ciudad de Buenos Aires | Buenos Aires F.D. | |
| Instituto de Investigaciones Metabolicas ( Site 2700) | Buenos Aires | Argentina | |
| Hospital Aleman ( Site 2702) | Buenos Aires | Argentina | |
| Kinghorn Cancer Centre ( Site 2200) | Darlinghurst | New South Wales | |
| MNCCI Port Macquarie Base Hospital ( Site 2201) | Port Macquarie | New South Wales | |
| Linear Clinical Research Ltd ( Site 2202) | Nedlands | Western Australia | |
| Sunnybrook Research Institute ( Site 0210) | Toronto | Ontario | |
| Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203) | Montreal | Quebec | |
| Jewish General Hospital ( Site 0209) | Montreal | Quebec | |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 | Québec | Quebec | |
| Fundacion Centro de Investigacion Clinica CIC ( Site 2812) | Medellín | Antioquia | |
| Rodrigo Botero SAS ( Site 2801) | Medellín | Antioquia | |
| Biomelab S A S ( Site 2800) | Barranquilla | Atlántico | |
| Administradora Country SA - Clinica del Country ( Site 2802) | Bogotá | Bogota D.C. | |
| Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807) | Bogotá | Bogota D.C. |
+ 90 more sites — see the full list on the official registry below.
On this site
📄 Lynparza (olaparib) drug profile →More Merck Sharp & Dohme LLC trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03742895 on ClinicalTrials.gov ↗ ← All trials in Italy