Olaparib + Pembrolizumab for Advanced Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.

Eligibility Criteria

Adults with advanced solid tumors that have specific genetic mutations or deficiencies, who've had some response to platinum-based therapies and are not eligible for curative treatment. They must be in relatively good health, agree to contraception, and not be pregnant or breastfeeding. Exclusions include certain blood disorders, active infections or autoimmune diseases, recent treatments with other cancer drugs or vaccines, and known allergies to trial medications.

Inclusion Criteria

My cancer has harmful mutations in specific genes related to DNA repair.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I am not on high-dose steroids or other drugs that weaken my immune system.

I have received an organ or tissue transplant from another person.

I have not had major surgery in the last 2 weeks or am fully recovered from any major surgery.

My cancer has spread to my brain or spinal cord.

I have been treated with immunotherapy targeting specific cancer growth pathways.

I have an autoimmune disease treated with medication in the last 2 years.

I am currently being treated for an infection.

I am not taking strong or moderate inhibitors of CYP3A4 that can't be stopped for the study.

I have been diagnosed with HIV.

I have had a bone marrow or cord blood transplant.

I have or had lung inflammation not caused by infection, treated with steroids.

I have active hepatitis B or C.

I cannot take pills by mouth or have a condition that affects how my body absorbs medication.

I do not have any uncontrolled heart conditions.

I am not taking strong or moderate drugs that affect drug metabolism and can't stop them for the study.

I have been treated with olaparib or another PARP inhibitor before.

I have been diagnosed with MDS, AML, or conditions that suggest I might have them.

I have active tuberculosis.

Treatment Details

The trial is testing the combination of two drugs: Olaparib (MK-7339), which targets cancer cells with DNA repair issues; and Pembrolizumab (MK-3475), an immunotherapy drug. The study aims to see how well these drugs work together in treating patients whose tumors have specific genetic features making them hard to treat.

1Treatment groups

Experimental Treatment

Group I: Olaparib+PembrolizumabExperimental Treatment2 Interventions

Participants receive olaparib 300 mg via oral tablet 2 times each day PLUS pembrolizumab 200 mg via intravenous infusion on Day 1 of each 21-day cycle. Participants may receive olaparib+pembrolizumab for up to approximately 2 years.

Olaparib is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Lynparza for: