Study on Low Dose Chemotherapy Followed by Olaparib and Pembrolizumab for Metastatic Pancreatic Ductal Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04753879

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment plan for patients with metastatic pancreatic ductal cancer. The plan includes a combination of low dose chemotherapy drugs followed by maintenance therapy with olaparib and pembrolizumab.

Patient Parameters

Program Overview

The aim of this study is to evaluate how safe and effective a new treatment approach is for patients with metastatic pancreatic ductal cancer. Initially, patients will receive a combination of low dose chemotherapy drugs, including gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI). After this, they will receive maintenance therapy with olaparib and pembrolizumab to see if it helps control the cancer.

Eligibility Criteria

Inclusion Criteria

  • Patients with stable or progressing pancreatic cancer after receiving GAX-CI chemotherapy.
  • Must be able to understand and sign a consent form.
  • Aged 18 years or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Have metastatic pancreatic ductal cancer confirmed by lab tests.
  • No prior treatment for pancreatic cancer.
  • Have measurable cancer based on specific criteria.
  • Willing to undergo a tumor biopsy.
  • Have adequate organ and bone marrow function as shown by lab tests.
  • Women of childbearing age must have a negative pregnancy test and agree to use birth control.
  • Men must agree to use birth control during the study.
  • Understand the study requirements, risks, and medication schedule.

Exclusion Criteria

  • Patients eligible for surgery.
  • Had chemotherapy within the last 5 years.
  • Received investigational drugs within 28 days before the study.
  • Had surgery within 28 days before starting the study treatment.
  • History of cancer spread to the brain or spinal cord.
  • Need for any cancer treatment other than the study drugs.
  • Previous treatment with certain cancer drugs or antibodies.
  • Allergic reaction to monoclonal antibodies.
  • Taking certain medications that affect the liver.
  • Have uncontrolled medical conditions.
  • Have another progressing cancer needing treatment.
  • Received radiotherapy for pancreatic cancer.
  • Had a live vaccine or certain therapies within 30 days before the study.
  • Participating in another clinical trial or using an investigational device recently.
  • Have an active autoimmune disease.
  • Receiving chronic steroid therapy recently.
  • History of organ or bone marrow transplant.
  • Any condition that might affect study results or participation.
  • Need for daily oxygen.
  • History of lung disease needing steroids.
  • Have a significant wound.
  • History of brain infections or seizures.
  • HIV infection.
  • Active Hepatitis B or C infection.
  • Uncontrolled infection.
  • Unwilling to have blood tests.
  • Psychiatric or substance use disorder affecting participation.
  • Pregnant or breastfeeding women.

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