14 Participants Needed

Pembrolizumab + Olaparib for Breast Cancer

PM
AO
Overseen ByAmy Oppenheim
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial will evaluate the use of immunotherapy and PARP inhibition in a population with incurable advanced breast cancer associated with a germline BRCA mutation or HDR-defect. The main objective is to examine overall response rate of pembrolizumab (immunotherapy) in combination with Olaparib (PARP inhibitor) in advanced BRCA-mutated or Homology-directed repair (HDR)-defect breast cancer.

Research Team

Yuan Yuan, MD, PhD | Cedars-Sinai

Yuan Yuan, MD PhD

Principal Investigator

Cedars-Sinal Medical Center

Eligibility Criteria

This trial is for adults with advanced breast cancer that's linked to a BRCA mutation or HDR-defect. Participants must have measurable disease, adequate organ function, and a life expectancy of at least 16 weeks. Women should be postmenopausal or use two forms of contraception; men must use condoms. Exclusions include recent other treatments, additional cancers needing treatment, inability to take oral meds, certain infections like HIV/Hepatitis B/C, active autoimmune diseases, and known allergies to the drugs tested.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.
My organs are functioning well.
You are expected to live for at least 16 more weeks.
See 7 more

Exclusion Criteria

I am not on steroids or immunosuppressants as of three days ago.
I have a history of HIV or active Hepatitis B/C.
I have an autoimmune disease treated with medication in the last 2 years.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab in combination with Olaparib for advanced BRCA-mutated or HDR-defect breast cancer

Up to 2 years
Assessments every 9 weeks during the first year and every 12 weeks thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

  • Olaparib
  • Pembrolizumab
Trial Overview The study tests pembrolizumab (an immunotherapy drug) combined with olaparib (a PARP inhibitor) in patients with incurable advanced breast cancer due to BRCA mutations or HDR defects. The main goal is to see how well this combination works by measuring the overall response rate according to specific criteria.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + OlaparibExperimental Treatment2 Interventions
This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy.

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

🇪🇺
Approved in European Union as Lynparza for:
  • Breast cancer
  • Ovarian cancer
  • Fallopian tube cancer
  • Peritoneal cancer
  • Pancreatic cancer
  • Prostate cancer
  • Endometrial cancer
🇺🇸
Approved in United States as Lynparza for:
  • Ovarian, fallopian tube, and primary peritoneal cancer
  • Breast cancer
  • Prostate cancer
  • Pancreatic cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yuan Yuan

Lead Sponsor

Trials
2
Recruited
30+

Monica Mita

Lead Sponsor

Trials
3
Recruited
100+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
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Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

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Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

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