Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

January 28, 2019

Primary Completion Date

March 4, 2022

Study Completion Date

March 4, 2022

Conditions
Metastatic Melanoma
Interventions
DRUG

Placebo for antibiotic

Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout.

DRUG

Vancomycin pretreatment

Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout.

DRUG

Nivolumab

Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks.

DRUG

Matching Placebo for SER-401

Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase.

DRUG

SER-401

Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

77030

MD Anderson Cancer Center, Houston

84112

Huntsman Cancer Institute, Salt Lake City

90025

The Angeles Clinic and Research Institute, Los Angeles

02114

Massachusetts General Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
collaborator

Seres Therapeutics, Inc.

INDUSTRY

lead

Parker Institute for Cancer Immunotherapy

OTHER

NCT03817125 - Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention | Biotech Hunter | Biotech Hunter