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PARP Inhibitor

Olaparib + Pembrolizumab for Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has achieved complete response (CR), partial response (PR), or stable disease (SD) based on RECIST 1.1 by Blinded Independent Central Review (BICR) at the Week 18 evaluation

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 7 days prior to the start of induction study treatment

Must not have

Has an active infection requiring systemic therapy

Has had major surgery within 2 weeks of starting study treatment or has not recovered from any effects of any major surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 29 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the efficacy of two different treatments for triple negative breast cancer - olaparib plus pembrolizumab versus chemotherapy plus pembrolizumab. The primary hypotheses are that olaparib plus pembrolizumab will be superior to chemotherapy plus pembrolizumab in terms of progression-free survival and overall survival.

Who is the study for?

This trial is for adults with triple negative breast cancer (TNBC) that's either inoperable and not previously treated with chemotherapy, or metastatic without prior chemo. Participants should have a life expectancy of at least 27 weeks, be in good physical condition (ECOG status of 0 or 1), have adequate organ function, and agree to use contraception. Pregnant or breastfeeding women, those with certain other cancers or conditions like active CNS metastases, autoimmune diseases requiring recent treatment, severe infections including HIV/Hepatitis B/C, heart failure within the past six months, uncontrolled illnesses that could affect study participation are excluded.

What is being tested?

The study compares two treatments after initial chemo plus pembrolizumab: one group will receive olaparib plus pembrolizumab while the other continues on standard chemotherapy plus pembrolizumab. The goal is to see which combination is better at stopping cancer progression (PFS) and improving survival rates (OS). Enrollment has stopped but ongoing participants can continue if benefiting.

What are the potential side effects?

Possible side effects include allergic reactions to medication components; issues from immune system activation such as inflammation in organs; blood disorders; fatigue; digestive problems; increased risk of infection due to weakened immunity. Specifics depend on individual responses and may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has not worsened by Week 18 according to a specific assessment.

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

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

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I have only mild side effects from my initial cancer treatment, not including hair loss.

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My triple-negative breast cancer is either inoperable and untreated by chemotherapy, or it has spread and hasn't been treated with chemotherapy.

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I've had 4 to 6 rounds of initial cancer treatment without stopping pembrolizumab, carboplatin, or gemcitabine.

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I can start the required medication doses after initial treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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I haven't had major surgery in the last 2 weeks or still recovering from one.

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

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I have not had a live vaccine in the last 30 days.

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I am allergic to pembrolizumab, olaparib, carboplatin, gemcitabine, or their components.

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I have been treated with specific immune therapy drugs or was in a study for pembrolizumab.

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I have cancer that has spread to my brain or spinal cord.

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I have stopped any medications that can't be taken with the study drugs 7 days before starting the trial.

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I have a history of Hepatitis B or active Hepatitis C.

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I have had a bone marrow or cord blood transplant.

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I have an active case of tuberculosis.

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

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I have moderate to severe nerve pain or damage.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I stopped taking carboplatin and gemcitabine because of side effects.

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I am taking medication that strongly affects liver enzymes and cannot stop during the study.

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I stopped taking pembrolizumab because of side effects.

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

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I have been treated for an autoimmune disease in the last 2 years.

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I have been diagnosed with MDS/AML or have symptoms suggesting it.

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I am taking medication that strongly affects liver enzymes and can't stop during the study.

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I have or had lung disease that affects the tissue and space around the air sacs.

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I've had fewer than 4 rounds of chemo with pembrolizumab.

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I have had lung inflammation that needed steroids or have it now.

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I have not taken any colony-stimulating factors in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 29 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 29 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 29 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Progression-Free Survival (PFS)

Secondary study objectives

Change From Baseline in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score in Participants With BRCAm Tumors

Change From Baseline in Emotional Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 21-24 Score

Change From Baseline in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Combined Score in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pembrolizumab + OlaparibExperimental Treatment2 Interventions

This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.

Group II: Pembrolizumab + Carboplatin + GemcitabineExperimental Treatment3 Interventions

This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Pembrolizumab

2017

Completed Phase 3

~2810