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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 29 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS)
Secondary outcome measures
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 moreTrial 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
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Olaparib
2007
Completed Phase 4
~2210
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,535 Total Patients Enrolled
18 Trials studying Breast Cancer
5,570 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,907 Previous Clinical Trials
5,065,556 Total Patients Enrolled
59 Trials studying Breast Cancer
7,406 Patients Enrolled for Breast Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,789 Previous Clinical Trials
8,066,790 Total Patients Enrolled
7 Trials studying Breast Cancer
1,743 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a recent biopsy (within 3 years) of a tumor that wasn't treated with radiation.I am currently being treated for an infection.I am not pregnant or breastfeeding, can test negative for pregnancy, and will use birth control or abstain from sex.I have had serious heart failure or a heart attack in the last 6 months.I haven't had major surgery in the last 2 weeks or still recovering from one.I have received an organ or tissue transplant from another person.I still have side effects from past treatments that haven't fully gone away.I have not had a live vaccine in the last 30 days.I agree to use contraception or remain abstinent and not donate sperm while on the study drugs and for 95 days after.I am allergic to pembrolizumab, olaparib, carboplatin, gemcitabine, or their components.I have been treated with specific immune therapy drugs or was in a study for pembrolizumab.I have cancer that has spread to my brain or spinal cord.I have stopped any medications that can't be taken with the study drugs 7 days before starting the trial.You have been diagnosed with HIV.My cancer has not worsened by Week 18 according to a specific assessment.I have not had active treatment for another cancer, except for certain skin cancers or in situ cancers, in the last 5 years.I have been treated with anthracycline or taxane for my cancer unless it was not suitable for me.I have a history of Hepatitis B or active Hepatitis C.I have had a bone marrow or cord blood transplant.I have an active case of tuberculosis.I cannot take pills by mouth or have a condition that affects how my body absorbs them.I have moderate to severe nerve pain or damage.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I stopped taking carboplatin and gemcitabine because of side effects.I am taking medication that strongly affects liver enzymes and cannot stop during the study.I stopped taking pembrolizumab because of side effects.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with olaparib or another PARP inhibitor before.I have been treated for an autoimmune disease in the last 2 years.I have been diagnosed with MDS/AML or have symptoms suggesting it.You are expected to live for at least 27 weeks from the start of the study treatment.I am taking medication that strongly affects liver enzymes and can't stop during the study.I have or had lung disease that affects the tissue and space around the air sacs.I had radiotherapy less than 2 weeks before starting the study treatment.You have a very bad allergic reaction (Grade 3 or higher) to the study medications or any of their ingredients.Have a disease that can be measured using specific guidelines.I've had fewer than 4 rounds of chemo with pembrolizumab.I have had lung inflammation that needed steroids or have it now.I don't have health issues that could affect the study's results or my participation.My organs are functioning well, as tested within the last 10 days.I have not taken any colony-stimulating factors in the last 2 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I have only mild side effects from my initial cancer treatment, not including hair loss.My triple-negative breast cancer is either inoperable and untreated by chemotherapy, or it has spread and hasn't been treated with chemotherapy.I've had 4 to 6 rounds of initial cancer treatment without stopping pembrolizumab, carboplatin, or gemcitabine.I can start the required medication doses after initial treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Olaparib
- Group 2: Pembrolizumab + Carboplatin + Gemcitabine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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