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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
No Placebo-Only Group

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 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Ciprofloxacin
2014
Completed Phase 4
~8080
Metronidazole
2011
Completed Phase 4
~3810
Surgical Resection
2018
Completed Phase 2
~420
FOLFIRINOX
2013
Completed Phase 3
~800
Biopsy
2014
Completed Phase 4
~1150
Pembrolizumab
2017
Completed Phase 3
~3130

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
913 Previous Clinical Trials
572,776 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
~15 spots leftby Aug 2027
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