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)

Running, not enrolling · Phase 2

Conditions studied: Advanced Solid Neoplasms

In brief

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 facts

Study ID: NCT03742895
Run by: Merck Sharp & Dohme LLC
People needed: 329
Starts: 2018-12-12
Expected to finish: 2027-06-30
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For all participants:
Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by the local site Investigator/radiology and confirmed by Blinded independent central review (BICR).
Is able to provide a newly obtained core or excisional biopsy of a tumor lesion or either an archival formalin-fixed paraffin embedded (FFPE) tumor tissue block or slides.
Has a life expectancy of at least 3 months.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 7 days of treatment initiation.
Male participants must agree to use contraception during the treatment period and for at least 95 days (3 months and 5 days) after the last dose of study treatment and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a woman of childbearing potential (WOCBP).
Is a WOCBP and using a contraceptive method that is highly effective with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 180 days after the last dose of study intervention, AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. Abstains from breastfeeding during the study intervention period and for at least 30 days after the last dose of study intervention.
Has adequate organ function.
For participants who have non-breast or -ovarian cancers that are breast cancer susceptibility gene 1/2 (BRCA1/2) mutated (BRCAm), or who have cancers that are BRCA1/2 non-mutated and homologous recombination repair non-mutated:
Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except ovarian cancer whose tumor has a germline or somatic BRCA mutation and breast cancer whose tumor has a germline BRCA mutation) that is not eligible for curative treatment and for which standard of care therapy has failed. Participants must have progressed on or be intolerant to standard of care therapies that are known to provide clinical benefit. There is no limit on the number of prior treatment regimens.
Has either centrally-confirmed known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally-confirmed HRD.
For participants receiving prior platinum (cisplatin, carboplatin, or oxaliplatin either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor, have no evidence of disease progression during the platinum chemotherapy or ≤4 weeks of completing the platinum-containing regimen.
For participants who have somatic BRCAm breast cancer:
Has histologically- or cytologically-confirmed breast cancer with evidence of metastatic disease.
Has a known or suspected deleterious mutation in BRCA1 or BRCA2 and does not harbor a germline BRCA1 or BRCA2 mutation - testing can be done centrally or locally. Blood and tissue samples must be provided by all participants.
Has received treatment with an anthracycline unless contraindicated and a taxane in either the neoadjuvant/adjuvant or metastatic setting.
Participants with estrogen and/or progesterone receptor-positive disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.

You may not qualify if…

Has a known additional malignancy that is progressing or has required active treatment in the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Participants with previously treated brain metastases may participate if radiologically stable, clinically stable, and without requirement for steroid treatment for at least 14 days prior to the first dose of study treatment.
Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment.
Has a known history of human immunodeficiency virus (HIV) infection.
Has known active hepatitis infection (i.e., Hepatitis B or C).
Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (poly[ADP ribose]) polymerization (PARP) inhibitor.
Has a known hypersensitivity to the components or excipients in olaparib.
Has received previous allogenic bone-marrow transplant or double umbilical cord transplantation (dUCBT).
Has received a whole blood transfusion in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable if not performed within 28 days of the first dose of study treatment.
Has received any anti-neoplastic systemic chemotherapy or biological therapy, targeted therapy, or an anticancer hormonal therapy within 3 weeks prior to the first dose of study intervention.
Has a primary cancer of unknown origin.
Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.

Where it is running

St Joseph Heritage Healthcare-Oncology ( Site 0056) — Fullerton, California, United States
Cedars Sinai Medical Center ( Site 0002) — Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007) — San Francisco, California, United States
Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092) — Aurora, Colorado, United States
Winship Cancer Institute of Emory University ( Site 0025) — Atlanta, Georgia, United States
Augusta University ( Site 0028) — Augusta, Georgia, United States
Markey Cancer Center ( Site 0018) — Lexington, Kentucky, United States
University of Maryland ( Site 0050) — Baltimore, Maryland, United States
Weinberg Cancer Institute at Franklin Square ( Site 0054) — Baltimore, Maryland, United States
University of Massachusetts ( Site 0017) — Worcester, Massachusetts, United States
Henry Ford Health System ( Site 0060) — Detroit, Michigan, United States
Cancer Partners of Nebraska ( Site 0051) — Lincoln, Nebraska, United States
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116) — Middletown, New Jersey, United States
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126) — Harrison, New York, United States
VA New York Harbor Healthcare System Manhattan ( Site 0094) — New York, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057) — New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0026) — New York, New York, United States
Southwestern Regional Medical Center, Inc. ( Site 0079) — Tulsa, Oklahoma, United States
Eastern Regional Medical Center, Inc. ( Site 0077) — Philadelphia, Pennsylvania, United States
Sanford Hematology Oncology-Sioux Falls SD ( Site 0012) — Sioux Falls, South Dakota, United States
Intermountain Healthcare ( Site 0043) — St. George, Utah, United States
Virginia Mason Medical Center ( Site 0052) — Seattle, Washington, United States
Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093) — Seattle, Washington, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703) — Berazategui, Buenos Aires, Argentina
The University of Arizona Cancer Center - North Campus ( Site 0011) — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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