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PARP Inhibitor
Pembrolizumab + Olaparib for Pancreatic Cancer
Phase 2
Recruiting
Led By Wungki Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, skin reactions, and flu-like symptoms. Olaparib can lead to nausea, fatigue, blood cell count changes, shortness of breath, and potential kidney issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival (PFS)
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Olaparib
2007
Completed Phase 4
~2190
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pembrolizumab and olaparib are promising treatments for pancreatic cancer due to their targeted mechanisms of action. Pembrolizumab activates the immune system by inhibiting the PD-1 pathway, enabling T-cells to better attack cancer cells.
Olaparib, a PARP inhibitor, prevents cancer cells from repairing DNA damage, leading to cell death, particularly in those with BRCA mutations or other homologous recombination repair deficiencies. These treatments are significant for pancreatic cancer patients as they offer more effective and personalized therapeutic options, potentially improving outcomes for those with specific genetic profiles.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,493 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,920 Total Patients Enrolled
Wungki Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 are currently receiving platinum-based therapy as part of your first or second-line treatment plan.Patients will be grouped based on their genetic makeup and how well they respond to treatment.You have had a bone marrow transplant using cells from a donor.Certain genetic variations in 17 specific genes are not relevant to this study and will not disqualify you from being part of the study. However, if you have a positive response to platinum-based treatment, you may be eligible for a different group in the study.You are able to perform daily activities and take care of yourself with little to no assistance.You have a weakened immune system.You have taken any medication that affects your entire body within the past 2 weeks.The trial is for people who have already received platinum-based chemotherapy as their first or second line of treatment.Patients will be grouped based on their genetic makeup and how they respond to treatment.You have another type of cancer, but there are some exceptions.You have cancer that has not worsened or has improved with your current chemotherapy treatment.If you had surgery for your cancer and it came back more than 6 months after your last treatment, you may be eligible if your disease is stable or responding to platinum therapy, and you meet certain genetic or platinum sensitivity criteria.If you have certain genetic changes in genes called BRCA1/2 or PALB2 and your disease is stable or responding after first or second-line platinum therapy for at least 4 months, you can participate in Cohort A.You have a weak immune system or you have been taking medication that weakens your immune system within the last week before starting the study.Cohort B is for patients who have genetic mutations in certain HR-genes (ATM, BAP1, BARD1, BLM, BRIP1, CHEK2, FAM175A, FANCA, FANCC, MUTYH, NBN, RAD50, RAD51, RAD51C, RTEL1) and have shown improvement or stability in their disease after receiving platinum therapy.You have been diagnosed with advanced pancreatic cancer that has spread, and your cancer has specific gene changes or you have responded well to platinum-based treatments in the past.You have trouble swallowing pills or have a gastrointestinal disorder that affects how medication is absorbed.You don't have any of the gene mutations mentioned in Cohort A and B but have responded well to platinum-based therapy for at least 4 months. If you have gene mutations that are not fully understood, you may still be eligible if you meet the same response criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort C: Platinum sensitive
- Group 2: Cohort A: Core HRD
- Group 3: Cohort B: Non core HRD
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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