Study on Pembrolizumab and Olaparib for People with Advanced Pancreatic Cancer and Specific Genetic Traits or Good Response to Platinum Therapy

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04666740

Provider View

This clinical trial is exploring whether a combination of two drugs, pembrolizumab and olaparib, can be more effective than olaparib alone in treating people with advanced pancreatic cancer who have certain genetic traits or have responded well to platinum-based treatments.

Patient Parameters

Program Overview

Researchers are investigating if combining pembrolizumab, which boosts the immune system, with olaparib, which prevents cancer cells from repairing themselves, can better treat advanced pancreatic cancer. This study focuses on patients with specific genetic traits or those who have shown a good response to platinum-based chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Currently receiving platinum-based chemotherapy for advanced pancreatic cancer and showing stable or improved disease.
  • Diagnosed with metastatic pancreatic adenocarcinoma or acinar cell carcinoma with specific genetic changes or sensitivity to platinum therapy.
  • Patients will be grouped based on their genetic changes and response to treatment:
    • Group A: Patients with changes in BRCA1/2 or PALB2 genes and stable or improved disease on platinum therapy.
    • Group B: Patients with changes in other specific genes and stable or improved disease on platinum therapy.
    • Group C: Patients without these genetic changes but showing a good response to platinum therapy.
  • Recurrence after surgery is eligible if it occurred more than 6 months after the last treatment and the disease is stable or improving on platinum therapy.
  • Good overall health with an ECOG performance status of 0-2.
  • Normal organ and bone marrow function based on recent blood tests.
  • Women must be postmenopausal or have a negative pregnancy test and agree to use contraception if of childbearing potential.

Exclusion Criteria

  • Disease progression on current platinum therapy.
  • Having another active cancer, except for certain treated skin or cervical cancers.
  • Heart rhythm issues shown by specific EKG results.
  • Blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Previous bone marrow transplant.
  • Uncontrolled brain metastases or spinal cord compression.
  • Difficulty swallowing or gastrointestinal issues affecting medication absorption.
  • Immune system deficiencies or on high-dose steroids.
  • Active hepatitis B or C, or HIV.
  • Previous treatment with PARP inhibitors or certain immune therapies.
  • Recent systemic therapy or investigational drugs.
  • Recent live vaccines.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • Recent major surgery or radiation therapy.
  • Use of certain medications that interact with the study drugs.

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