Study on Modulating Gut Microbiome with Pembrolizumab After Chemotherapy in Resectable Pancreatic Cancer

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05462496

Provider View

This clinical trial is exploring a new treatment approach for pancreatic cancer that can be surgically removed. It involves using antibiotics and the drug pembrolizumab after chemotherapy to see if it can improve immune response and control the cancer.

Patient Parameters

Program Overview

This study is testing a new treatment for pancreatic cancer that can be surgically removed. It involves using antibiotics and pembrolizumab, a type of immunotherapy, after chemotherapy. The main goal is to see if this combination can activate the immune system to fight the cancer more effectively. Researchers also want to find out if this approach is safe and if it can help shrink the tumors before surgery. The study will also look at changes in the gut bacteria and how these changes might affect the cancer and the immune system.

Description

This study is a pilot trial, meaning it's an early-stage study to test a new treatment approach. The main goals are to see if using antibiotics and pembrolizumab after chemotherapy can activate the immune system in pancreatic cancer patients and to check if this treatment is safe and feasible. Researchers will also look at how the treatment affects the gut bacteria and the immune system, and whether these changes help in reducing the cancer.

Participants will receive antibiotics and pembrolizumab after completing chemotherapy. The study will involve several procedures, including tumor biopsies, surgery, blood tests, and stool samples. The treatment will last for about a week, and participants will be monitored for six months. The study will take place at multiple centers, including Mount Sinai Health System, and aims to enroll 25 participants.

The study will measure the immune response by looking at specific markers on immune cells. It will also track any side effects, the success of tumor removal surgery, and overall survival rates. Researchers will analyze changes in the immune system and gut bacteria to understand how they relate to the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic adenocarcinoma that can be surgically removed.
  • Cancer must be at a specific stage and confirmed by imaging tests.
  • Age 18 or older.
  • Must agree to undergo biopsies and surgery.
  • Good overall health with a performance status of 0 or 1.
  • No prior treatment for pancreatic cancer.
  • Normal organ and blood function based on specific tests.
  • Ability to understand and sign a consent form.
  • Women must not be pregnant or breastfeeding and must use effective birth control during and after the study.
  • Men must use effective birth control if their partners are women of childbearing potential.

Exclusion Criteria

  • Cancer that is not resectable or has spread too far.
  • Medical conditions that make surgery too risky.
  • Active autoimmune diseases requiring treatment in the past 2 years.
  • Significant lung or heart disease.
  • Active infections or recent use of antibiotics or probiotics.
  • Known HIV or active hepatitis infections.
  • Recent history of diverticulitis or chronic diarrhea.
  • Pregnant or breastfeeding women.
  • Recent participation in another drug study or major surgery.
  • Allergies to study drugs or their components.

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