Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors

Phase 1 & 2

Waitlist Available

Led By Shubham Pant, MD

Research Sponsored by 4D pharma plc

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 day 1 of cycle 1 and cycle 2, time of treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days), and 30 day follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of MRx0518 capsules and pembrolizumab infusions in patients with certain types of solid tumors. The goal is to enhance the body's natural defenses to better fight off cancer cells.

Eligible Conditions

Non-Small Cell Lung Cancer
Melanoma
Solid Tumors
Kidney Cancer
Cancer
Bladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of cycle 1 and cycle 2, time of treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days), and 30 day follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of cycle 1 and cycle 2, time of treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days), and 30 day follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of cycle 1 and cycle 2, time of treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days), and 30 day follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: To assess the safety and tolerability of MRx0518 in combination with pembrolizumab through the collection of adverse events

Part B: To assess safety and tolerability of MRx0518 in combination with pembrolizumab through the collection of adverse events

Part B: To assess the clinical benefit of MRx0518 in combination with pembrolizumab

Secondary study objectives

Antitumour effect

Other study objectives

Biomarkers of treatment effect - blood

Biomarkers of treatment effect - tumour

Microbiota and metabolome

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MRx0518 with pembrolizumabExperimental Treatment2 Interventions

Subjects will receive IV infusion of pembrolizumab once every 3 weeks until disease progression, unacceptable AEs or withdrawal of consent up to a maximum of 35 cycles (approx. 2 years). Starting on the day of first pembrolizumab dose, subjects will take one capsule of MR0518 twice daily until the end of the treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

2019

Completed Early Phase 1

~10

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