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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 2 Study of Olaparib in Combination with Pembrolizumab in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK7339-007, KEYLYNK)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04123366

Background Information

The purpose of this study is to test the safety of the study drugs pembrolizumab and olaparib in combination. This study will see how well the drugs work together and see how the body handles the drugs. The study will test if the combination of pembrolizumab and olaparib may improve disease status, delay progression of disease and help patients live longer.

Pembrolizumab has been approved for use in certain types of cancers; however, it may not be for your type of cancer. Olaparib has been approved for use in certain types of cancers; however, it may not be for your type of cancer. Pembrolizumab in combination with olaparib is considered experimental. “Experimental” means that the combination of study drugs is currently being tested for your type of cancer. It is not approved by the U.S. FDA to treat your type of cancer.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Solid tumor cancer patients 18 years of age or older
  • Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor 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
  • Additional eligibility in protocol

Ineligibility Information

  • Breast or ovarian cancers whose tumor has a germline or somatic BRCA mutation
  • A history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis
  • Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Additional ineligibility in protocol