Study on Adding Pembrolizumab to Olaparib for Treating Pancreatic Cancer with Inherited BRCA Mutations

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04548752

Provider View

This clinical trial is exploring whether combining the immunotherapy drug pembrolizumab with the standard treatment olaparib is more effective than olaparib alone for patients with pancreatic cancer that has spread and has specific inherited BRCA mutations.

Patient Parameters

Program Overview

This study is testing if adding pembrolizumab, an immunotherapy drug, to the usual treatment with olaparib can better treat pancreatic cancer that has spread in patients with inherited BRCA1 or BRCA2 mutations. These mutations can make it harder for cells to repair DNA, leading to cancer. Pembrolizumab may help the immune system attack cancer cells, while olaparib blocks a protein that helps repair DNA, potentially causing cancer cells to die. The study aims to see if this combination can shrink tumors more effectively than olaparib alone.

Description

The main goal of this study is to see if the combination of olaparib and pembrolizumab can help patients with advanced pancreatic cancer live longer without the disease getting worse, compared to using olaparib alone.

Secondary goals include:

  • Checking the safety and side effects of the combination treatment.
  • Comparing the overall survival rates between the two treatment groups.
  • Measuring how well the tumors respond to the treatments.
  • Determining how long any positive response lasts.

The study will also collect tissue and blood samples for future research.

Participants will be randomly assigned to one of two groups:

  • Group A: Will receive olaparib pills twice a day and pembrolizumab through an IV every 21 days for up to 18 cycles. After 18 cycles, the treatment schedule changes slightly.
  • Group B: Will receive olaparib pills twice a day every 21 days.

Throughout the study, participants will have regular scans, biopsies, and blood tests to monitor their health and the cancer's response to treatment. After finishing the study treatment, participants will be followed up for 30 days and then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must have pancreatic cancer confirmed by lab tests, excluding certain rare types.
  • Must have inherited BRCA1 or BRCA2 mutations confirmed by a certified lab.
  • Cancer must have spread and been treated with specific chemotherapy regimens.
  • Must have stable or responding cancer on recent scans.
  • Must be HIV-negative or have controlled HIV with treatment.
  • Must have controlled hepatitis B or C if previously infected.
  • Must have completed at least 16 weeks of first-line chemotherapy.
  • Must have had recent chemotherapy within 30 days.
  • Must have resolved or stable side effects from previous treatments.
  • Must not be allergic to olaparib or its ingredients.
  • Must not be taking certain medications that interact with olaparib.
  • Must not have received live vaccines recently.
  • Must not have had previous treatments with certain immune or PARP inhibitors.
  • Must not have a history of immune system deficiencies or be on high-dose steroids.
  • Must be in good general health with a performance status of 0-1.
  • Must be 18 years or older.
  • Must have recent medical exams and lab tests showing adequate organ function.
  • Must not be pregnant or nursing and agree to use contraception if of childbearing potential.
  • Must not have a history of lung inflammation requiring steroids.
  • Must not have active infections or autoimmune diseases needing treatment.
  • Must agree to participate in specimen banking for research.
  • Must understand and consent to the study's investigational nature.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.