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PD-1 Inhibitor

Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention (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

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

Skin Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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%

Hypernatraemia

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%

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%

Study treatment Arm

SER-401/ Nivolumab

SER-401 Matching Placebo/ 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

Vancomycin pretreatment

2019

Completed Phase 1

~20

SER-401

2019