Study on Maintenance Niraparib and Ipilimumab for Patients with Metastatic Pancreatic Cancer Stable on Platinum-Based Chemotherapy

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0

ClinicalTrials ID:NCT06747845

Provider View

This clinical trial is exploring whether the combination of the drugs niraparib and ipilimumab can help control pancreatic cancer that has spread and has not worsened after initial chemotherapy. The study compares this combination to standard chemotherapy treatment.

Patient Parameters

Program Overview

The main aim of this study is to see if the combination of niraparib and ipilimumab can effectively slow down the growth of pancreatic cancer that has spread to other parts of the body. Participants will be divided into two groups: one group will receive niraparib and ipilimumab, while the other group will receive standard chemotherapy. The study will also monitor any side effects experienced by participants taking niraparib and ipilimumab. Participants will undergo initial health screenings, be assigned to one of the two treatment groups, and attend regular clinic visits for checkups and tests.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic pancreatic adenocarcinoma.
  • Aged 18 years or older.
  • Able to understand and agree to participate in the study by signing a consent form.
  • Have received 8-12 cycles of first-line chemotherapy (FOLFIRINOX or NALIRIFOX) with stable disease or better.
  • Willing to undergo tumor biopsies if medically possible.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
  • Men must agree to use contraception during and after the study.
  • Have adequate organ function as shown by specific blood tests.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Previous treatment with PARP inhibitors, ipilimumab, or similar drugs.
  • Resistance to FOLFIRINOX chemotherapy.
  • Genetic mutations in certain cancer-related genes.
  • Known mismatch repair deficiency or high microsatellite instability.
  • Uncontrolled digestive issues affecting drug absorption.
  • Uncontrolled high blood pressure.
  • History of certain brain conditions.
  • Recent serious infections requiring IV treatment.
  • History of autoimmune diseases, except for certain stable conditions.
  • History of lung disease or non-infectious lung inflammation.
  • Recent live vaccinations.
  • Refusal to use contraception during and after the study.
  • Recent treatment for pancreatic cancer or participation in another clinical trial.
  • Need for high-dose steroids or immunosuppressive drugs.
  • Recent severe blood disorders from chemotherapy.
  • Recent surgery without full recovery.
  • Substance abuse issues.
  • Other conditions that may increase study risks or affect results.
  • History of certain blood disorders or leukemia.
  • Active hepatitis B or C infections.
  • HIV-positive patients must have an undetectable viral load and be on stable treatment.
  • Known brain or spinal fluid metastases.

Locations

FACILITYZIPCITYSTATE
Dana-Farber Cancer Institute02215BostonMassachusetts
University of Pennsylvania, Abramson Cancer Center19104PhiladelphiaPennsylvania

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