Actively Recruiting
Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer
Led by Icahn School of Medicine at Mount Sinai · Updated on 2024-10-15
25
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multi-institutional, single arm pilot study of antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.
CONDITIONS
Official Title
Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed pancreatic adenocarcinoma; other histologies or mixed types are not eligible
- Clinical stage T1-3, N0-2, M0 according to AJCC 8th edition
- Surgically resectable pancreatic cancer based on NCCN 2.2021 guidelines and dual-phase CT imaging
- No arterial tumor contact with celiac axis, superior mesenteric artery, or common hepatic artery
- No tumor contact or limited contact (≤180° without vein irregularity) with superior mesenteric vein or portal vein
- Age over 18 years
- Agreement to pre-treatment biopsy, on-treatment biopsy, and definitive surgical resection
- ECOG performance status of 0 or 1
- No prior treatment for pancreatic cancer diagnosis
- Normal organ and marrow function meeting specified blood count and chemistry criteria
- Ability to understand and sign informed consent and comply with study procedures
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraceptive measures during and after treatment
- Male participants sexually active with women of childbearing potential must agree to contraception and refrain from sperm donation during and after treatment
You will not qualify if you...
- Borderline resectable, locally advanced, or metastatic pancreatic cancer
- Medical conditions contraindicating definitive surgical resection due to high risk
- Active autoimmune disease requiring systemic treatment in past 2 years
- Conditions requiring systemic corticosteroids exceeding 10 mg prednisone daily
- Symptomatic interstitial lung disease or conditions interfering with pulmonary toxicity management
- Uncontrolled or significant cardiovascular disease
- Active infection requiring recent antibacterial, antiviral, or antifungal therapy
- Chronic use of systemic antibiotics or antifungals
- Uncontrolled inflammatory gastrointestinal diseases such as Crohn's or ulcerative colitis
- Known active or suspected autoimmune disease
- Receipt of live or live-attenuated vaccines within 30 days prior to study drug
- Use of probiotics within 28 days prior to screening
- Known HIV, active Hepatitis A or B infection
- History of acute diverticulitis in last 6 months or current chronic diarrhea
- Expected need for other antineoplastic or surgical therapies during study
- Pre-existing peripheral neuropathy greater than grade 1
- Pregnant or lactating women
- Positive pregnancy test in women of childbearing potential within 72 hours before registration
- Women of childbearing potential unwilling or unable to use contraception
- Sexually active fertile men not using effective birth control if partners are women of childbearing potential
- History of primary immunodeficiency
- History or current pneumonitis/interstitial lung disease requiring steroids
- History of organ or bone marrow transplant
- Prior radiation, immunotherapy, or targeted therapy for pancreatic tumor
- Treatment for other invasive cancers within last 2 years with >5% recurrence risk
- Participation in investigational drug study within 4 weeks before treatment start
- Major surgery within 4 weeks before treatment start without full recovery
- Allergy to study treatments or their components
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
D
Deirdre Cohen, MD
CONTACT
R
Rashmi Unawane
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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