Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Colorectal Neoplasms
  • 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

NCT number NCT04729322
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 22, 2021
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05691491 - Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness Phase 1/Phase 2
Terminated NCT04832763 - Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer N/A
Active, not recruiting NCT04164069 - Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab Phase 1
Active, not recruiting NCT03981614 - Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer Phase 2
Recruiting NCT05863195 - Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial Phase 3
Active, not recruiting NCT03983993 - Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer Phase 2
Completed NCT04597151 - Diet Education Program for Stage I-IV Colorectal Cancer Survivors N/A
Not yet recruiting NCT05518032 - Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC) Phase 2
Recruiting NCT05803382 - Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers Phase 1
Not yet recruiting NCT05356897 - Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study Phase 2
Recruiting NCT04314401 - National Cancer Institute "Cancer Moonshot Biobank"
Suspended NCT04111172 - A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma Phase 2
Recruiting NCT05627635 - FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer Phase 1/Phase 2
Active, not recruiting NCT04362839 - Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer Phase 1
Recruiting NCT05672316 - Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy Phase 1/Phase 2
Recruiting NCT05733000 - CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors Phase 2
Active, not recruiting NCT04117945 - Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer Phase 2
Active, not recruiting NCT02983578 - Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer Phase 2
Recruiting NCT04693377 - Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial N/A
Recruiting NCT06265285 - Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program Phase 2