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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3-4 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3-4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3-4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Achievement of overall immune response
Secondary outcome measures
Adverse event incidence rate
Overall response rate (ORR)
Overall survival rate (OS)
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
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
Metronidazole
2011
Completed Phase 4
~4360
Pembrolizumab
2017
Completed Phase 2
~2010
Surgical Resection
2018
Completed Phase 2
~420
Biopsy
2014
Completed Phase 4
~1090
FOLFIRINOX
2013
Completed Phase 3
~790
Ciprofloxacin
2014
Completed Phase 4
~8080
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,473 Total Patients Enrolled
Deirdre Cohen, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have HIV or active Hepatitis A or B.I will not need cancer treatment or surgery other than the study.My cancer is at a stage where surgery might not remove it all, or it has spread.I had major surgery less than 4 weeks ago and haven't fully recovered.I agree to undergo initial, during-treatment, and final surgical biopsies.I have or had lung inflammation that needed steroids.I do not have severe nerve damage in my hands or feet.You have had a condition that weakens your immune system since you were born.I have received radiation, immunotherapy, or targeted therapy for my pancreatic cancer.My pancreatic cancer can be surgically removed.My organ and bone marrow functions are normal.My tumor does not touch or only slightly touches the main veins in my abdomen without causing any shape changes.Surgery for my pancreatic cancer is too risky due to other health issues.I have not taken probiotics in the last 28 days.I am older than 18 years.I have had a severe intestinal infection or ongoing diarrhea recently.My diagnosis is pancreatic cancer, confirmed by tissue analysis.I am fully active or can carry out light work.I am not pregnant and follow the required birth control measures.I have not received any treatment for pancreatic cancer.I have serious heart problems that are not under control.I haven't needed treatment for a serious infection in the last 28 days.I had cancer treatment within the last 2 years and my risk of cancer coming back is more than 5%.I have been treated for an autoimmune disease in the last 2 years.I have had an organ or bone marrow transplant from another person.I am a man and will follow the study's birth control rules if my partner can have children.My tumor does not touch the main arteries near my liver.My cancer is in an early to mid-stage and hasn't spread far.I have symptoms of lung scarring.
Research Study Groups:
This trial has the following groups:- Group 1: Participants who had Chemotherapy Following Pancreatic Adenocarcinoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you enlighten me about the security profiles of Pembrolizumab for human subjects?
"Although no efficacy data is available, there have been some studies affirming the safety of Pembrolizumab which earned it a score of 2."
Answered by AI
Are participants currently being accepted for the trial?
"As indicated on clinicaltrials.gov, this medical experiment is no longer actively recruiting participants; the initial posting was made on August 1st 2022 and the last update happened a little over two weeks ago. Nevertheless, 699 other trials remain in search of patients to participate."
Answered by AI
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