Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05462496
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Pre-treatment tumor biopsy
  • FOLFIRINOX — DRUG
    Patients will receive FOLFIRINOX chemotherapy every 2 weeks for 5 cycles. One cycle of mFOLFIRINOX = 14 days. Cycles of mFOLFIRINOX are delivered as follows\*: * Oxaliplatin: 85 mg/m2 IV over 2 hours on Day 1, followed by, * Irinotecan: 150 mg/m2 IV over 90 minutes on Day 1, followed by, * Leucovorin\*\*: 400 mg/m2 IV over 2 hours on Day 1, followed by, * 5FU: 2400 mg/m2 IV over 46-48 hours on Days 1-3
  • Ciprofloxacin — DRUG
    Ciprofloxacin and metronidazole will be initiated 7 days following 5th dose of FOLFIRINOX. Subjects will self-administer ciprofloxacin 500mg PO BID on days 1-21. Participants will be instructed to take the antibiotics with food to minimize stomach upset and to administer at the same time each day. Treatment with antibiotics will continue for 21 days unless there is unacceptable toxicity or disease progression. Subjects will record date, time and number of tablets they take on provided drug diaries.
  • Metronidazole — DRUG
    Ciprofloxacin and metronidazole will be initiated 7 days following 5th dose of FOLFIRINOX. Subjects will self-administer metronidazole 500mg PO every 8 hours on days 1-21. Participants will be instructed to take the antibiotics with food to minimize stomach upset and to administer at the same time each day. Treatment with antibiotics will continue for 21 days unless there is unacceptable toxicity or disease progression. Subjects will record date, time and number of tablets they take on provided drug diaries.
  • Pembrolizumab — DRUG
    Pembrolizumab will be initiated 7 days post initiation of antibiotics. Subjects will receive a flat dose of pembrolizumab 200mg IV over 30 minutes.
  • Surgical Resection — PROCEDURE
    Following completion of 21 days of antibiotics, participant will undergo repeat imaging studies. If there is no progressive disease which renders participant surgically unresectable (based on NCCN guidelines 2.2021), subject will undergo definitive surgical resection.

Study Details

A multi-institutional, single arm pilot study of antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.

Key Dates

Start date
Mar 16, 2023
Status verified
Oct 2024
Primary completion
Aug 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants who had Chemotherapy Following Pancreatic Adenocarcinoma
    Participants to be given antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.

Primary Outcome Measure

Achievement of overall immune response [ Time Frame: at day 43 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Katherine Vandris
[email protected]
Deirdre Cohen, MD
[email protected]
Deirdre Cohen (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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