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Live Biotherapeutic Product

MRx0518 for Non-Small Cell Lung Cancer

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
Failure to respond or intolerance to standard therapy or for whom no appropriate therapies are known to provide clinical benefit (per the judgement of the Investigator).
Have adequate organ function
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

Study Summary

This trial is testing a new drug, MRx0518, in combination with pembrolizumab to see if it is safe and effective in treating patients with solid tumors.

Eligible Conditions
  • Cancer
  • Non-Small Cell Lung Cancer
  • Kidney Cancer
  • Melanoma
  • Bladder Cancer
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have already tried standard treatments, but they didn't work or you couldn't tolerate them. There are no other known treatments that can help you, according to the opinion of the researcher.
Select...
Your organs are working well enough to participate in the study.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Antitumour effect
Other outcome measures
Biomarkers of treatment effect - blood
Biomarkers of treatment effect - tumour
Microbiota and metabolome
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,637 Total Patients Enrolled
4D pharma plcLead Sponsor
8 Previous Clinical Trials
551 Total Patients Enrolled
Shubham Pant, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
152 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different venues is this research taking place?

"Five medical facilities are currently enrolling for this clinical trial, namely the University of Kansas Medical Center in Kansas City, Houston Methodist Cancer Center in Houston and Summit Cancer Center in Spokane. Additionally, there are five other locations participating across the US."

Answered by AI

What ailment is MRx0518 normally utilized to treat?

"MRx0518 is an effective treatment for malignant neoplasms, inoperable melanoma, and cases of microsatellite instability high."

Answered by AI

Is this trial currently accessible for participants?

"This particular clinical trial has since ended its recruitment process. It was first posted on the 10th of January 2019, and last updated on 5 July 2022. Nevertheless, if you're looking for other studies related to melanoma, there are 4209 trials recruiting patients; or alternatively 961 studies actively searching for participants with MRx0518."

Answered by AI

Can you provide insight into any other experiments involving MRx0518?

"Currently, 961 clinical trials are collecting data on the efficacy of MRx0518 with 122 Phase 3 studies. Houston, Texas is at the centre of many of these research programs but there are 35731 different locations offering this medication to participants."

Answered by AI

How many individuals are actively engaged in this clinical experiment?

"At this time, recruitment for this trial has been suspended. It was first listed on the 10th of January 2019 and last modified on July 5th 2022. There are presently 4209 studies recruiting patients with melanoma and 961 trials seeking participants for treatment with MRx0518."

Answered by AI
~10 spots leftby Mar 2025