← Back to Search

PD-1 Inhibitor

SER-401 for Melanoma (MCGRAW Trial)

Phase 1
Waitlist Available
Research Sponsored by Parker Institute for Cancer Immunotherapy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial tests a pill that changes gut bacteria and a drug that helps the immune system fight cancer in patients with advanced skin cancer. The goal is to see if this combination is safe and effective.

Eligible Conditions
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Patients With Adverse Events (AEs)
Secondary study objectives
Absolute Change in the Percentage of CD8 Cells in Tumor Tissue From Baseline at Cycle 2.
Disease Control Rate (DCR)
Duration of Response
+4 more

Side effects data

From 2022 Phase 1 trial • 14 Patients • NCT03817125
75%
Fatigue
63%
Arthralgia
38%
Back pain
25%
Pain in extremity
25%
Flatulence
25%
Dizziness
25%
Blood creatinine increased
25%
Hypothyroidism
25%
Anaemia
25%
Rash pustular
25%
Haematuria
13%
Myalgia
13%
Eructation
13%
Primary adrenal insufficiency
13%
Chills
13%
Nausea
13%
Diarrhoea
13%
Abdominal pain
13%
Dry mouth
13%
Oral pain
13%
Muscular weakness
13%
Rash
13%
Axillary mass
13%
Pruritus
13%
Vitiligo
13%
Rash maculo-papular
13%
Hypernatraemia
13%
Blood thyroid stimulating hormone increased
13%
Hyperglycaemia
13%
Headache
13%
Syncope
13%
Hemiparesis
13%
Phantom limb syndrome
13%
Adrenal insufficiency
13%
Fall
13%
Testicular pain
13%
Cough
13%
Hypertension
13%
Raynaud's phenomenon
100%
80%
60%
40%
20%
0%
Study treatment Arm
SER-401 Matching Placebo/ Nivolumab
SER-401/ Nivolumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SER-401/ NivolumabExperimental Treatment3 Interventions
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.
Group II: SER-401 Matching Placebo/ NivolumabPlacebo Group3 Interventions
Participants will undergo a 4-day lead-in pretreatment with antibiotic placebo, then matching placebo for SER-401 and nivolumab (480 mg) treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
SER-401
2019
Completed Phase 1
~20
Vancomycin pretreatment
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Seres Therapeutics, Inc.Industry Sponsor
8 Previous Clinical Trials
951 Total Patients Enrolled
Parker Institute for Cancer ImmunotherapyLead Sponsor
11 Previous Clinical Trials
450 Total Patients Enrolled
3 Trials studying Melanoma
41 Patients Enrolled for Melanoma
~2 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top