Trials / Terminated
TerminatedNCT03637803
Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors
A Phase I/II Open Label, Safety And Preliminary Efficacy Study of MRx0518 In Combination With Pembrolizumab In Patients With Advanced Malignancies Who Have Progressed On PD-1/PD-L1 Inhibitors
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- 4D pharma plc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRx0518 | MRx0518 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is one capsule two times per day for the duration of the treatment period. |
| DRUG | Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] | Pembrolizumab is a potent humanised immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD1) receptor , thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). The study dosing regimen is 200mg (two 4ml vials of 25mg/ml solution) for IV infusion once every three weeks. |
Timeline
- Start date
- 2019-01-10
- Primary completion
- 2023-05-08
- Completion
- 2023-05-08
- First posted
- 2018-08-20
- Last updated
- 2023-06-01
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03637803. Inclusion in this directory is not an endorsement.