Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention

Part of paid clinical trials in Los Angeles, California.

Sponsor
Parker Institute for Cancer Immunotherapy
Study ID
NCT03817125
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo for antibiotic — DRUG
    Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout.
  • Vancomycin pretreatment — DRUG
    Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout.
  • Nivolumab — DRUG
    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.
  • Matching Placebo for SER-401 — DRUG
    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.
  • SER-401 — DRUG
    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.

Study Details

This study is designed to evaluate the safety and tolerability of treatment with oral microbiome study intervention (SER-401) or matching placebo in combination with anti-programmed cell death 1 (anti-PD-1) therapy (nivolumab) in participants with unresectable or metastatic melanoma. The study also intends to assess clinical outcomes, the impact of microbiome study intervention administration on the microbiome profile, and its association with clinical and immunological outcomes.

Key Dates

Start date
Jan 28, 2019
Status verified
Jun 2024
Primary completion
Mar 4, 2022
Completion
Mar 4, 2022

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: SER-401 Matching Placebo/ Nivolumab
    Participants will undergo a 4-day lead-in pretreatment with antibiotic placebo, then matching placebo for SER-401 and nivolumab (480 mg) treatment.
  • Experimental: SER-401/ Nivolumab
    Participants will undergo a 4-day lead-in pretreatment with antibiotic (vancomycin) to prime the gut microbiome for engraftment of the oral microbiome study intervention, then SER-401 and nivolumab treatment.

Primary Outcome Measure

Percentage of Patients With Adverse Events (AEs) [ Time Frame: Up to 2 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
The Angeles Clinic and Research Institute· Los Angeles, CADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MARutgers Cancer Institute of New Jersey· New Brunswick, NJMemorial Sloan Kettering Cancer Center· New York, NYMD Anderson Cancer Center· Houston, TX

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