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Fecal Microbial Transplantation in Combination With Immunotherapy in Melanoma Patients (MIMic)

StatusActive, Not Recruiting
PhasePhase 1
Started2019-03-27
View on ClinicalTrials.gov ↗

Amendment history

2025-03-26
minor
Study Status, Oversight v9
Completion date2024-12→2026-08
2024-02-28
minor
Study Status v8
Primary completion dateestimated 2023-12→confirmed 2021-09-14
Completion date2023-12→2024-12
2023-06-22
minor
2 amendments v6-v7
2 re-verifications since 2021-12-14, no change to tracked fields
2021-11-16
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 3 of 3 sites
2020-09-11
minor
Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v4
Study sites1→3
Study arms0→1
Secondary endpoints4 to 7 entries
Evaluate the effect(s) combination FMT and immunotherapy has on changes in immune blood biomarkers Evaluate the effect(s) combination FMT and immunotherapy has on changes in immune blood biomarkers Evaluate the effect(s) combination FMT and immunotherapy has on changes in immune blood biomarkers
Show 3 earlier versions
2019-06-25
minor
Study Status, Contacts/Locations v3
Re-verified, no change to tracked fields
2019-05-03
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-04→confirmed 2019-03-27
Study sites0→1
2019-02-27
minor
Study Status, Contacts/Locations v1
Start date2018-12→2019-04
2018-12-10
minor
Original filing
Immunotherapy has helped many cancer patients in the last 5 years by enhancing a patient's immune system to fight cancer. Anti-Programmed Death (PD-1) immunotherapy drugs such as pembrolizumab and nivolumab remove the breaks from cancer-fighting immune cells and have been effective in treating some melanoma patients. Despite the major breakthrough of immunotherapy in oncology treatment, many patients do not respond to this new class of anti-cancer drugs. Recently, evidence suggests that the microorganisms living in a patient's intestines play a major role in modifying the response to anti-PD-1drugs. Patients who respond to these drugs have a unique and healthy group of microorganisms in their gut. Therefore, positive modification of a cancer patient's gut microorganisms to create a more diverse and healthy microbiome may improve the response to immunotherapy. One method of modifying the microbiome is Fecal Microbial Transplantation (FMT) that is already being successfully used in the clinic to treat non-cancer patients with persistent bacterial infections. In this study, the investigators will combine FMT with the approved immunotherapy drugs pembrolizumab or nivolumab that are the standard of care for the treatment of advanced melanoma. The purpose of this study is to examine the safety of combining these two therapies in melanoma patients. The investigator will use fecal material from a healthy donor selected via our stringent protocol that is Health Canada approved. In addition to assessing the safety of the combination, the investigator will also study the effect of FMT on the immune system and microbial ecosystem of the gut.
Trial Details
NCT Number NCT03772899
Lead Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions Melanoma
Enrollment 20 participants
Start Date 2019-03-27
Primary Completion 2021-09-14 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-03-28