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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 provided a recently obtained or archival (no more than 3 years old) core or excisional biopsy of a tumor lesion not previously irradiated
Has been treated with anthracycline and/or a taxane in the neoadjuvant/adjuvant setting, if they received systemic treatment in the neoadjuvant/adjuvant setting, unless anthracycline and/or taxane was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician
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 below
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I have a recent biopsy (within 3 years) of a tumor that wasn't treated with radiation.
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I have been treated with anthracycline or taxane for my cancer unless it was not suitable for me.
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I am not pregnant or breastfeeding, can test negative for pregnancy, and will use birth control or abstain from sex.
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I agree to use contraception or remain abstinent and not donate sperm while on the study drugs and for 95 days after.
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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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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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My organs are functioning well, as tested within the last 10 days.
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I have a recent biopsy of my tumor that was not treated with radiation.
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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 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

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 more

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
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Olaparib
2007
Completed Phase 4
~2140
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
4,581,358 Total Patients Enrolled
18 Trials studying Breast Cancer
5,570 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,871 Previous Clinical Trials
5,051,743 Total Patients Enrolled
58 Trials studying Breast Cancer
7,456 Patients Enrolled for Breast Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,770 Previous Clinical Trials
8,061,587 Total Patients Enrolled
7 Trials studying Breast Cancer
1,743 Patients Enrolled for Breast Cancer

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04191135 — Phase 2
Breast Cancer Research Study Groups: Pembrolizumab + Olaparib, Pembrolizumab + Carboplatin + Gemcitabine
Breast Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04191135 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04191135 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What mitigating measures are taken to ensure the safe use of Pembrolizumab?

"While there is evidence of Pembrolizumab's safety, no clinical data exists for its efficacy in this Phase 2 trial; thereby earning it a score of 2."

Answered by AI

What are the anticipated outcomes of this clinical research?

"Merck Sharp & Dohme Corp., the sponsor of this study, has declared Overall Survival (OS) as its primary outcome that will be monitored for a maximum of 72 months. Secondary outcomes to be evaluated include Change From Baseline in Health-Related Quality-of-Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Change From Baseline in Emotional Functioning With The EORTC QLQ-C30, and Time To Deterioration in HRQoL Utilizing The EOR"

Answered by AI

What is the size of the cohort participating in this research?

"At the present moment, this specific study is not enrolling. It was posted on December 19th 2019 and last updated on October 10 2022; if you wish to explore other options, there are 2351 trials actively recruiting patients with triple negative breast neoplasms and 2018 studies involving Pembrolizumab that require participants."

Answered by AI

Are volunteers currently being accepted for this experiment?

"Currently, this clinical trial is not accepting new participants. Initially posted on December 19th 2019 and last updated October 10th 2022, the study has been suspended for now. For individuals seeking out other trials, 2351 studies are actively searching for people with triple negative breast neoplasms while 2018 medical research projects centered around Pembrolizumab require enrollees."

Answered by AI

To what extent has research been conducted on Pembrolizumab?

"At the present time, there are 2018 clinical trials underway exploring Pembrolizumab. Of these studies, 419 are in Phase 3 and have a global presence with 89680 being conducted across various locations worldwide; notably, Shanghai is hosting many of them."

Answered by AI

What are the venues in which this study is being conducted?

"This trial is being conducted at 30 different settings, including Texas Oncology-New Braunfels (Site 0168) in New Braunfels, McGill University Health Centre ( Site 0002) in Montreal, and MSKCC-Bergen (Site 0162) situated in Montvale."

Answered by AI

What maladies are typically treated by Pembrolizumab?

"Pembrolizumab is approved for use in treating a variety of cancers, such as non-Hodgkin's lymphoma and recurrent cervical cancer, as well as malignant melanomas on the skin."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)
What portion of applicants met pre-screening criteria?
Met criteria
~88 spots leftby Apr 2025