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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
Study Summary
This trial is testing whether adding pembrolizumab to olaparib will be more effective than olaparib alone for treating ovarian cancer.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Overall survival (OS)
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
~2010
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,818 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,890 Previous Clinical Trials
5,060,202 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA validated Pembrolizumab for use?
"Pembrolizumab was judged to be a 2 on the safety scale due to its Phase 2 trial status, indicating that there is evidence of it being safe but no confirmation as yet of its efficacy."
Answered by AI
What is the current count of participants in this clinical experiment?
"Affirmative. According to information on clinicaltrials.gov, this research initiative is currently seeking participants; it was initially posted in December 2020 and modified most recently in November 2022. The investigation requires 63 subjects from 7 distinct trial centres."
Answered by AI
Is this the inaugural trial of its kind?
"Since its original trial in 2005, sponsored by AstraZeneca and involving 98 patients, the Phase 1 approval of Pembrolizumab was granted. Currently there are 1114 ongoing studies focusing on this medication across 66 countries and 3058 cities worldwide."
Answered by AI
Could you provide an estimate of the amount of Canadian medical centers participating in this experiment?
"Seven clinical centres are recruiting participants for this trial, including Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities) in Commack, and two other sites located in Harrison and New york. Another four recruitment locations exist across the nation."
Answered by AI
What maladies does Pembrolizumab serve to ameliorate?
"Pembrolizumab is a viable treatment for those with unresectable melanoma, high levels of microsatellite instability, and an elevated risk of recurrence."
Answered by AI
What other experiments utilizing Pembrolizumab have been conducted?
"As of this moment, 1114 trials regarding Pembrolizumab are underway. 143 of these studies have advanced to Phase 3 and can be found at 42747 sites with a major concentration in Houston, Texas."
Answered by AI
Is it feasible to join the experiment at this point in time?
"As seen on clinicaltrials.gov, this research endeavour is still actively recruiting participants; the trial was initially posted on December 18th 2020 and updated most recently on November 9th 2022."
Answered by AI
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