Pembrolizumab for Colorectal Cancer

M D Anderson Cancer Center, Houston, TX
Colorectal Cancer+6 More ConditionsPembrolizumab - Biological
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Metastatic Small Intestinal Adenocarcinoma
  • Metastatic Colorectal Cancer
  • Stage IV Colorectal Cancer
  • Stage IV Small Intestinal Adenocarcinoma
  • Stage IVA Colorectal Cancer
  • Stage IVC Colorectal Cancer
  • Stage IVB Colorectal Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Fecal Microbiota Transplantation
1
Fecal Microbiota Transplantation
1
Treatment (loperamide, colonoscopy, FMT)

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Up to 3 years post-treatment

Year 3
Objective response rate

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Fecal Microbiota Transplantation
1
Fecal Microbiota Transplantation
1
Treatment (loperamide, colonoscopy, FMT)

Side Effects for

Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Dyspnoea
17%Asthenia
16%Vomiting
14%Dizziness
14%Pyrexia
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Pruritus
11%Insomnia
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Hypokalaemia
7%Blood creatinine increased
7%Abdominal pain
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Dyspepsia
5%Dysphagia
5%Blood alkaline phosphatase increased
5%Chest pain
5%Musculoskeletal pain
5%Hyperthyroidism
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Hypotension
4%Urinary tract infection
2%Death
2%Pulmonary embolism
2%Acute kidney injury
2%Pneumonitis
2%Atrial fibrillation
1%Hemiparesis
1%Inappropriate antidiuretic hormone secretion
1%Superior vena cava syndrome
1%Neutropenic sepsis
1%Transient ischaemic attack
1%Diabetes mellitus
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

Arm I (FMT, pembrolizumab)
1 of 2
Arm II (FMT, nivolumab)
1 of 2

Experimental Treatment

15 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Arm I (FMT, pembrolizumab)Experimental Group · 8 Interventions: Pembrolizumab, Vancomycin, Biopsy, Fecal Microbiota Transplantation, Fecal Microbiota Transplantation Capsule, Metronidazole, Neomycin, Questionnaire Administration · Intervention Types: Biological, Drug, Procedure, Procedure, Drug, Drug, Drug, Other
Arm II (FMT, nivolumab)Experimental Group · 7 Interventions: Vancomycin, Nivolumab, Biopsy, Fecal Microbiota Transplantation, Fecal Microbiota Transplantation Capsule, Metronidazole, Questionnaire Administration · Intervention Types: Drug, Biological, Procedure, Procedure, Drug, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Vancomycin
FDA approved
Nivolumab
FDA approved
Biopsy
2014
Completed Phase 4
~1120
Fecal Microbiota Transplantation
2016
Completed Phase 2
~330
Metronidazole
FDA approved
Neomycin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years post-treatment

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,235,383 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,849 Previous Clinical Trials
1,793,509 Total Patients Enrolled
Michael J OvermanPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
303 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your doctor believes you are likely to live for at least four more months.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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