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PD-1 Inhibitor
Fecal Microbiota Transplant + Anti-PD-1 Therapy for Metastatic Colorectal Cancer
Phase 2
Waitlist Available
Led By Michael J Overman
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years post-treatment
Awards & highlights
Study Summary
This trial is testing the effect of fecal microbiota transplants and re-introduction of anti-PD-1 therapy in treating people with colorectal cancer that has spread to other places in the body and who did not respond to anti-PD-1 therapy.
Who is the study for?
This trial is for adults with metastatic colorectal cancer that didn't respond to anti-PD-1 therapy. They must have a certain type of tumor (dMMR or MSI-H), good kidney and liver function, no severe allergies to pembrolizumab or nivolumab, not be pregnant, and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests if fecal microbiota transplants combined with pembrolizumab or nivolumab can help control metastatic colorectal cancer in patients who previously did not respond to anti-PD-1 therapies. It includes questionnaires, antibiotics before the transplant, biopsies, and follow-up assessments.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs due to pembrolizumab or nivolumab. The fecal transplant could cause digestive issues like bloating or discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Side 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
2Treatment groups
Experimental Treatment
Group I: Arm II (FMT, nivolumab)Experimental Treatment7 Interventions
Patients receive metronidazole PO Q8H on days -14 to -8 and then vancomycin PO Q6H and neomycin PO Q6H on days -8 to -6. Patients then undergo colonoscopic FMT on day -5.
POST-COLONOSCOPIC FMT: Patients receive standard of care nivolumab IV over 30 minutes on day 1. Patients also receive fecal microbiota transplantation capsule PO on days 1 and 8 of cycles 1-2. Beginning in cycle 4, patients receive fecal microbiota transplantation capsule PO on day 1 of every other cycle. Cycles repeat every 14 days for up to 6 months in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (FMT, pembrolizumab)Experimental Treatment8 Interventions
Patients receive metronidazole PO Q8H on days -14 to -8 and then vancomycin PO Q6H and neomycin PO Q6H on days -8 to -6. Patients then undergo colonoscopic FMT on day -5.
POST-COLONOSCOPIC FMT: Patients receive standard of care pembrolizumab IV over 30 minutes on day 1. Patients also receive fecal microbiota transplantation capsule PO on days 1, 8, and 15 of cycle 1. Beginning in cycle 2, patients receive fecal microbiota transplantation capsule PO on day 1. Cycles repeat every 21 days for up to 6 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
FDA approved
Nivolumab
FDA approved
Biopsy
2014
Completed Phase 4
~850
Fecal Microbiota Transplantation
2016
Completed Phase 2
~350
Metronidazole
FDA approved
Neomycin
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,787 Total Patients Enrolled
1 Trials studying Small Intestinal Adenocarcinoma
30 Patients Enrolled for Small Intestinal Adenocarcinoma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,652 Total Patients Enrolled
2 Trials studying Small Intestinal Adenocarcinoma
848 Patients Enrolled for Small Intestinal Adenocarcinoma
Michael J OvermanPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
303 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread and can be measured by scans.I don't have any health issues that could affect the study's results.My blood counts are within a healthy range.I haven't had cancer treatment in the last 2 weeks.I have not had major surgery in the last 4 weeks.I have not had radiotherapy in the last 2 weeks.I haven't had a live vaccine in the last 30 days.I do not have an ongoing autoimmune disease nor am I on long-term steroids.I am not severely allergic to pembrolizumab or nivolumab.I have not had severe side effects from previous immune therapy.I do not have an infection that needs treatment with medication.I do not have an immunodeficiency diagnosis.I am of childbearing age and have a negative pregnancy test.I am 18 years old or older.I have received at least 2 doses of a PD1/PD-L1 inhibitor.I can carry out all my usual activities without help.I am using highly effective birth control methods.My cancer diagnosis was confirmed through tissue examination.My tumor is identified as mismatch repair deficient or has high microsatellite instability.I am willing to have tumor biopsies when needed.My liver is working well.My cancer progressed despite anti-PD1/L1 therapy.My kidneys are working well.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (FMT, pembrolizumab)
- Group 2: Arm II (FMT, nivolumab)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pembrolizumab received government sanctioning for medical use?
"Pembrolizumab's safety is still being explored in clinical trials, so it received a score of 2."
Answered by AI
Could you please list other times Pembrolizumab has been studied?
"There are 1811 medical studies currently underway that involve Pembrolizumab. Out of those, 212 have reached Phase 3 clinical trials. Most of the research is being conducted in Houston, Texas; however, there are a total of 73787 locations worldwide where Pembrolizumab is being trialled."
Answered by AI
How many test subjects are there in this research project?
"According to the most recent information on clinicaltrials.gov, this research is still looking for volunteers. The trial was initially published on February 22nd, 2021 and had new updates as recently as October 12th, 2022. So far, 15 patients have been recruited from 1 institution."
Answered by AI
Are there any participants needed for this clinical trial at the moment?
"Active recruitment is underway for this clinical trial, which was originally posted on February 22nd, 2021 according to the listing on clinicaltrials.gov. The last edit occurred on October 12th, 2022."
Answered by AI
Pembrolizumab is a ___. It works by __.
"Pembrolizumab is most often used to treat melanoma that cannot be surgically removed. It can also help patients with microsatellite instability high, squamous cell carcinoma, and candidal vulvovaginitis manage their symptoms."
Answered by AI
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