Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

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

Study ID: NCT04729322

Conditions

Metastatic Colorectal Adenocarcinoma

Metastatic Small Intestinal Adenocarcinoma

Stage IV Colorectal Cancer AJCC v8

Stage IV Small Intestinal Adenocarcinoma AJCC v8

Stage IVA Colorectal Cancer AJCC v8

Stage IVB Colorectal Cancer AJCC v8

Stage IVC Colorectal Cancer AJCC v8

Interventions

Biopsy

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation Capsule

Questionnaire Administration

Vancomycin

Study Description

Brief Summary: 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.

Detailed Description: 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.