Pembrolizumab + Olaparib for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen ByWungki Park, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

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.

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.

Participant Groups

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.

3Treatment groups

Experimental Treatment

Group I: Cohort C: Platinum sensitiveExperimental Treatment2 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 HRDExperimental Treatment2 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 HRDExperimental Treatment2 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: