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Pembrolizumab + Chemotherapy for Pancreatic Cancer

Phase 2
Recruiting
Led By Deirdre Cohen, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior treatment for diagnosis of pancreatic cancer
Resectable pancreatic cancer as defined by NCCN Guidelines 2.2021 and based on pancreatic protocol dual-phase CT imaging
Must not have
Known human immunodeficiency virus (HIV), known active Hepatitis A, or known Hepatitis B
Borderline resectable, locally advanced or distant metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3-4 months
Awards & highlights

Summary

This trial is testing whether combining two drugs can better treat pancreatic cancer after surgery.

Who is the study for?
This trial is for adults over 18 with resectable pancreatic cancer who haven't had prior treatments. They must have normal organ function, no contact between the tumor and certain arteries or veins, and an ECOG performance status of 0 or 1. Participants need to consent to biopsies and surgery, use contraception if necessary, and not have autoimmune diseases, significant heart disease, recent major surgeries without recovery, active infections requiring treatment within the last month, HIV/Hepatitis A/B infection history or other conditions that would exclude them.
What is being tested?
The study tests a combination of antibiotics (Metronidazole and Ciprofloxacin) with Pembrolizumab immunotherapy following FOLFIRINOX chemotherapy in patients with operable pancreatic cancer. It's a single-arm pilot study where all participants receive the same treatment sequence including surgical resection of their tumors.
What are the potential side effects?
Possible side effects include reactions from antibiotics such as stomach upset or yeast infections; Pembrolizumab may cause immune-related issues like inflammation in organs or skin rashes; Chemotherapy can lead to nausea, fatigue, hair loss; Surgical procedures carry risks like bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not received any treatment for pancreatic cancer.
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My pancreatic cancer can be surgically removed.
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My tumor does not touch or only slightly touches the main veins in my abdomen without causing any shape changes.
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I am older than 18 years.
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My diagnosis is pancreatic cancer, confirmed by tissue analysis.
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I am fully active or can carry out light work.
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My tumor does not touch the main arteries near my liver.
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My cancer is in an early to mid-stage and hasn't spread far.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have HIV or active Hepatitis A or B.
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My cancer is at a stage where surgery might not remove it all, or it has spread.
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I had major surgery less than 4 weeks ago and haven't fully recovered.
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I have or had lung inflammation that needed steroids.
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I do not have severe nerve damage in my hands or feet.
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I have received radiation, immunotherapy, or targeted therapy for my pancreatic cancer.
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I have serious heart problems that are not under control.
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I haven't needed treatment for a serious infection in the last 28 days.
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Surgery for my pancreatic cancer is too risky due to other health issues.
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I have not taken probiotics in the last 28 days.
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I have had a severe intestinal infection or ongoing diarrhea recently.
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I had cancer treatment within the last 2 years and my risk of cancer coming back is more than 5%.
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I have been treated for an autoimmune disease in the last 2 years.
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I have had an organ or bone marrow transplant from another person.
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I have symptoms of lung scarring.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3-4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3-4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Achievement of overall immune response
Secondary study objectives
Adverse event incidence rate
Overall response rate (ORR)
Overall survival rate (OS)
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants who had Chemotherapy Following Pancreatic AdenocarcinomaExperimental Treatment6 Interventions
Participants to be given antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFIRINOX
2013
Completed Phase 3
~800
Metronidazole
2011
Completed Phase 4
~3810
Surgical Resection
2018
Completed Phase 2
~420
Biopsy
2014
Completed Phase 4
~1090
Ciprofloxacin
2014
Completed Phase 4
~8080
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
886 Previous Clinical Trials
535,040 Total Patients Enrolled
Deirdre Cohen, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
95 Total Patients Enrolled

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT05462496 — Phase 2
Pancreatic Cancer Research Study Groups: Participants who had Chemotherapy Following Pancreatic Adenocarcinoma
Pancreatic Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05462496 — Phase 2
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05462496 — Phase 2
~0 spots leftby Dec 2024
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