Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Small Intestinal Adenocarcinoma

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Metronidazole

Pembrolizumab

Vancomycin

Nivolumab

Neomycin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-Bacterial Agents

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

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.

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.

Biopsy

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation Capsule

Questionnaire Administration

Michael J Overman

This phase II trial studies the effect of fecal microbiota transplant and re-introduction of anti-PD-1 therapy (pembrolizumab or nivolumab) in treating anti-PD-1 non-responders with colorectal cancer that has spread to other places in the body (metastatic). Fecal microbiota transplants contain the normal bacteria and viruses found in fecal (stool) material. Immunotherapy with monoclonal antibodies, such as pembrolizumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab or nivolumab with fecal microbiota transplants may help to control the disease.

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of pembrolizumab or nivolumab in conjunction with fecal microbiota transplant (FMT) from PD-1 responding mismatch-repair deficiency (dMMR) colorectal cancer (CRC) patients for treatment of PD-1 non-responding dMMR CRC patient.

Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders

Pilot Trial of Fecal Microbiota Transplantation and Re-Introduction of Anti-PD-1 Therapy in dMMR Colorectal Adenocarcinoma Anti-PD-1 Non-Responders

Assessed by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST). Will be summarized by mean, standard error, and 95% confidence interval.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

single oral dose (s.d.) 160 mg (four 40 mg tablets) of regorafenib on two occasions (Day 1, Period 1, and Day 1, Period 2) separated by a washout period of at least 14 days

Regorafenib (Stivarga, BAY73-4506)

1 g tid (three times a day) regimen of Neomycin (oral) on five days in Period 2 starting 4 days before regorafenib intake on day 1 in period 2.

Bayer Study Director

To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy male subjects

Effect of Neomycin on the Pharmacokinetics of Regorafenib

Single-center, Open-label, Non-randomized, Two-period Sequential Treatment Study to Assess the Effect of Neomycin on the Pharmacokinetics of Regorafenib in Healthy Male Subjects

Bayer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders	NCT04729322	Metastatic Colo... Metastatic Smal... Stage IV Colore... Stage IV Small ... Stage IVA Color... Stage IVB Color... Stage IVC Color...	Biopsy Fecal Microbiot... Fecal Microbiot... Metronidazole Neomycin Nivolumab Pembrolizumab Questionnaire A... Vancomycin	18 Years -	M.D. Anderson Cancer Center
Effect of Neomycin on the Pharmacokinetics of Regorafenib	NCT02001909	Neoplasms	Regorafenib (St... Neomycin	18 Years - 45 Years	Bayer
Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders	NCT04729322	Metastatic Colo... Metastatic Smal... Stage IV Colore... Stage IV Small ... Stage IVA Color... Stage IVB Color... Stage IVC Color...	Biopsy Fecal Microbiot... Fecal Microbiot... Metronidazole Neomycin Nivolumab Pembrolizumab Questionnaire A... Vancomycin	18 Years -	M.D. Anderson Cancer Center
Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders	NCT04729322	Metastatic Colo... Metastatic Smal... Stage IV Colore... Stage IV Small ... Stage IVA Color... Stage IVB Color... Stage IVC Color...	Biopsy Fecal Microbiot... Fecal Microbiot... Metronidazole Neomycin Nivolumab Pembrolizumab Questionnaire A... Vancomycin	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for neomycin

Every month we try and update this database with for neomycin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for neomycin

Every month we try and update this database with for neomycin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for neomycin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.