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PARP Inhibitor

Pembrolizumab + Olaparib for Pancreatic Cancer

Phase 2

Recruiting

Led By Vincent Chung

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients with neuroendocrine tumors, acinar cell and adenosquamous carcinomas are excluded. All disease must be assessed and documented on the Baseline Tumor Assessment Form

Patients must be >= 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of registration to date of first documentation of progression or symptomatic deterioration (per response evaluation criteria in solid tumors [recist] 1.1), or death due to any cause, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding pembrolizumab to olaparib, which is the standard of care, is more effective in treating patients with metastatic pancreatic cancer who have BRCA1 or BRCA2 mutations.

Who is the study for?

This trial is for adults with metastatic pancreatic cancer who have inherited BRCA mutations. They must have completed first-line platinum-based chemotherapy, show stable or responding disease, and not be on certain drugs that affect olaparib. People with HIV or hepatitis C can join if treated and virus-free. Those with a history of severe lung inflammation, active infections, autoimmune diseases needing recent treatment, or other cancers that could interfere are excluded.

What is being tested?

The study is testing if adding pembrolizumab (an immunotherapy drug) to olaparib (a PARP inhibitor used as standard care) is more effective in treating patients whose pancreatic cancer has spread and have BRCA1/2 mutations. It's a phase II trial where the effectiveness of this combination will be compared to using olaparib alone.

What are the potential side effects?

Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from pembrolizumab, fatigue, nausea from both drugs; blood cell count changes; increased risk of infection; potential harm to unborn babies necessitating contraception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with pancreatic adenocarcinoma.

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I am 18 years old or older.

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I have never been treated with immune checkpoint inhibitors.

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I have never needed steroids for non-infectious lung inflammation.

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I have metastatic disease and have received first line platinum-based chemotherapy.

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I do not have an infection that needs treatment with medication.

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I have not been diagnosed with immunodeficiency or taken high-dose steroids or immunosuppressants in the last week.

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I can carry out all my usual activities without help.

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I have a hereditary BRCA 1 or 2 mutation confirmed by a certified lab.

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I have never been treated with PARP inhibitors.

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I can swallow pills and don't have stomach issues affecting medicine absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of registration to date of first documentation of progression or symptomatic deterioration (per response evaluation criteria in solid tumors [recist] 1.1), or death due to any cause, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of registration to date of first documentation of progression or symptomatic deterioration (per response evaluation criteria in solid tumors [recist] 1.1), or death due to any cause, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to date of first documentation of progression or symptomatic deterioration (per response evaluation criteria in solid tumors [recist] 1.1), or death due to any cause, assessed up to 3 years 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)

Secondary study objectives

Duration of response (DoR)

Incidence of adverse events

Overall response rate (ORR) per RECIST 1.1

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (olaparib, pembrolizumab)Experimental Treatment6 Interventions

Patients receive olaparib PO BID on days 1-21 and pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 19, patients receive olaparib PO BID on days 1-42 and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI, tumor biopsy and blood sample collection throughout the study.

Group II: Arm B (olaparib)Active Control5 Interventions

Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI, tumor biopsy and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030