Pembrolizumab + Olaparib for Pancreatic Cancer

Recruiting at 9 trial locations

Overseen By Eileen M O'Reilly, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 0

63 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, pembrolizumab and olaparib, to treat a specific type of cancer. Pembrolizumab helps the immune system fight cancer, while olaparib prevents cancer cells from fixing themselves. Researchers believe this combination might be more effective than using just one drug.

Research Team

Wungki Park, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with metastatic pancreatic cancer who have specific genetic changes or a good response to platinum-based therapy. They must be currently stable or improving on platinum treatment, not have other active cancers, and can't have had certain treatments like anti-PD-1 drugs before. Participants need normal organ function and no serious heart conditions.

Inclusion Criteria

Cohort B eligibility

Cohort C eligibility

You are currently receiving platinum-based therapy as part of your first or second-line treatment plan.

Exclusion Criteria

You have an autoimmune disease that has required treatment in the past two years.

You have received radiation therapy for symptom relief within the last two weeks before the start of the trial.

You have had a bone marrow transplant using cells from a donor.

Treatment Details

Interventions

• Olaparib
• Pembrolizumab

Trial Overview Researchers are testing if combining Pembrolizumab (boosts immune system against cancer) with Olaparib (stops cancer cells from repairing DNA damage) works better than just Olaparib alone for treating this type of pancreatic cancer.

Participant Groups

Group I: Cohort C: Platinum sensitive Experimental Treatment 2 Interventions

Patients without any of the above HR-gene alterations included in Cohort A and B who have platinum-sensitivity, which is defined as a partial response (PR) or complete response (CR) for the best overall response (BOR) during at least 4 months on platinumbased therapy. Variants of unknown significance of candidate HR-genes from Cohort A or B will be eligible for Cohort C if they meet the partial response to platinum criterion.

Group II: Cohort B: Non core HRD Experimental Treatment 2 Interventions

Patients with either pathogenic somatic or germline non-core 14 HR-gene alterations (ATM, BAP1, BARD1, BLM, BRIP1, CHEK2, FAM175A, FANCA, FANCC, NBN, RAD50, RAD51, RAD51C, RTEL1) who have stable or responding disease on first-line or second-line platinum therapy in two consecutive imaging assessments over at least 4 months are eligible for inclusion in Cohort B.

Group III: Cohort A: Core HRD Experimental Treatment 2 Interventions

Patients with either pathogenic germline or somatic alterations of 3 core homologous recombination-genes (HR-genes) - (BRCA1/2, or PALB2) who have stable or responding disease on first-line or second-line platinum therapy in two consecutive imaging assessments over at least 4 months are eligible for inclusion in Cohort A.

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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

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