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NCT03637803 · ClinicalTrials.gov registry record · Phase 1
Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors
A Phase 1 study, sponsored by 4D pharma.
- Terminated
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT03637803: Clinical Trial Phase 1 study, sponsored by 4D pharma.
NCT03637803 is a Phase 1 study that was terminated before completion, run by 4D pharma. The registered enrollment target is 63 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03637803, a Phase 1 study, was terminated before completion, sponsored by 4D pharma.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
This is an open label, safety and preliminary efficacy study of MRx0518 in combination with pembrolizumab in patients with solid tumours (non small cell lung cancer, renal cell carcinoma, bladder cancer or melanoma). Subjects will be treated with IV pembrolizumab every 3 weeks and 1 capsule twice daily of MRx0518. Treatment will continue as long as clinically relevant, until disease progression, unacceptable AEs or withdrawal of consent up to a maximum of 35 cycles (approx. 2 years).
Primary Outcome
Adverse events will be assessed as per CTCAE v4
Interventions
- DRUG Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
- DRUG MRx0518
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2019-01-10 |
| Est. Completion | 2023-05-08 |
| Phase | Phase 1 |
Why NCT03637803 stopped before completion
NCT03637803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] is the first listed.
NCT03637803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03637803 about?
NCT03637803 is a clinical study titled "Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors". This is an open label, safety and preliminary efficacy study of MRx0518 in combination with pembrolizumab in patients with solid tumours (non small cell lung cancer, renal cell carcinoma, bladder cancer or melanoma). Subjects will be treated with IV pembrolizumab every 3 weeks and 1 capsule twice d...
What is the current status of trial NCT03637803?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2019-01-10. Estimated completion is 2023-05-08.
What interventions are being tested in trial NCT03637803?
The interventions under investigation include: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] (DRUG), MRx0518 (DRUG).
Who is sponsoring clinical trial NCT03637803?
This trial is sponsored by 4D pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03637803's enrollment target sits among peer trials
63 820th of 2000 higher than 1,177 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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