drugset / Trial / NCT03637803

Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors

NCT03637803 ↗

Phase 1/2 Terminated 63 enrolled 4D pharma plc Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2019-01-10
Primary completion
2023-05-08
Completion
2023-05-08

Outcome

Outcome not reported

Stopped: “Sponsor insolvency”

Drugs

EvaluationDrugModalityDoseRoute
Subject MRx0518 Other / unclassified — —
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous