NCT03637803

Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors

Terminated Phase 1, PHASE2 Last updated 1 June 2023

What this trial tests

Phase 1, PHASE2 trial testing MRx0518 in Oncology in 63 participants. Terminated before completion.

Timeline

10 January 2019

Primary endpoint
8 May 2023

8 May 2023

Quick facts

Lead sponsor	4D pharma plc
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	63
Start date	10 January 2019
Primary completion	8 May 2023
Estimated completion	8 May 2023
Sites	5 locations across United States

Drugs / interventions tested

• MRx0518 — full drug profile →
• Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] — full drug profile →

Conditions studied

• Oncology — all drugs for Oncology →
• Solid Tumor — all drugs for Solid Tumor →
• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
• Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →

Sponsor

4D pharma plc — full company profile →

Who can join

18 and older, any sex, with Oncology or Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A review of cancer immunotherapy: from the past, to the present, to the future.
   Esfahani K, Roudaia L, Buhlaiga N, Del Rincon SV, et al · · 2020 · cited 652× · PMID 32368178 · DOI 10.3747/co.27.5223
2. Gut microbiota modulation: a novel strategy for prevention and treatment of colorectal cancer.
   Fong W, Li Q, Yu J. · · 2020 · cited 411× · PMID 32514151 · DOI 10.1038/s41388-020-1341-1
3. Gut microbiota influence immunotherapy responses: mechanisms and therapeutic strategies.
   Lu Y, Yuan X, Wang M, He Z, et al · · 2022 · cited 360× · PMID 35488243 · DOI 10.1186/s13045-022-01273-9
4. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
   Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
5. Cancer and the Microbiome-Influence of the Commensal Microbiota on Cancer, Immune Responses, and Immunotherapy.
   Matson V, Chervin CS, Gajewski TF. · · 2021 · cited 286× · PMID 33253684 · DOI 10.1053/j.gastro.2020.11.041
6. Modulating the microbiome to improve therapeutic response in cancer.
   McQuade JL, Daniel CR, Helmink BA, Wargo JA. · · 2019 · cited 283× · PMID 30712808 · DOI 10.1016/s1470-2045(18)30952-5
7. Cold and hot tumors: from molecular mechanisms to targeted therapy.
   Wu B, Zhang B, Li B, Wu H, et al · · 2024 · cited 280× · PMID 39420203 · DOI 10.1038/s41392-024-01979-x
8. The Oral Microbiome and Cancer.
   Irfan M, Delgado RZR, Frias-Lopez J. · · 2020 · cited 235× · PMID 33193429 · DOI 10.3389/fimmu.2020.591088