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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
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

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 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

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

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
3,966 Previous Clinical Trials
5,176,610 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
~9 spots leftby Oct 2025
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