What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as pembrolizumab and olaparib, have distinct side effect profiles. Pembrolizumab, which activates the immune system, often causes immune-related adverse events including fatigue, rash, diarrhea, and endocrine disorders like hypothyroidism. Olaparib, which prevents cancer cells from repairing genetic damage, frequently leads to nausea, fatigue, anemia, and other blood-related toxicities. Patients should discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including immune checkpoint inhibitors and PARP inhibitors. Pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), which can include pancreatic cancer. Olaparib, a PARP inhibitor, has been approved for pancreatic cancer patients with germline BRCA mutations. These approvals align with the mechanisms of action being studied in the trial combining pembrolizumab and olaparib, which aim to enhance the immune response and prevent cancer cell repair, respectively.

What other types of research exist?

Promising novel alternatives to Pembrolizumab and Olaparib for pancreatic cancer patients include: 1) Nivolumab, another immune checkpoint inhibitor that has shown efficacy in other cancers and could be considered for pancreatic cancer. 2) TGF-β inhibitors, which have shown potential in reducing metabolic changes and improving survival in pancreatic cancer models. 3) Combination therapies involving other immune checkpoint inhibitors like Tremelimumab or Avelumab, which target different pathways and may offer synergistic effects. These alternatives should be discussed with a healthcare provider to determine the best personalized treatment plan.

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PARP Inhibitor

Pembrolizumab + Olaparib for Pancreatic Cancer

Phase 2

Waitlist Available

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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2810

Olaparib

2007

Completed Phase 4

~2190

Do I qualify?Apply below to find out

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.