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Enrollment change, Trial completion date, Trial termination, Combination therapy, Metastases: KEYNOTE-823: Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors (clinicaltrials.gov) - Jun 1, 2023 P1/2, N=63, Terminated, Trial completion date: Oct 2023 --> May 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2023 --> May 2023; Sponsor insolvency N=132 --> 63 | Trial completion date: Mar 2024 --> May 2023 | Active, not recruiting --> Terminated; Sponsor insolvency
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Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Metastases: AVENU: Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma (clinicaltrials.gov) - Apr 18, 2023 P2, N=0, Withdrawn, This study demonstrates the long-term safety profile of MRx0518 therapy in treatment-na N=30 --> 0 | Trial completion date: Jan 2024 --> Apr 2023 | Active, not recruiting --> Withdrawn | Trial primary completion date: Oct 2023 --> Apr 2023
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Enrollment closed, Metastases: AVENU: Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma (clinicaltrials.gov) - Jul 6, 2022 P2, N=30, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Jul 2021 --> Oct 2023 | Trial primary completion date: Jul 2021 --> Jan 2023 Recruiting --> Active, not recruiting
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[VIRTUAL] Linking immunity and cancer to human microbiome () - Oct 21, 2020 - Abstract #BioEuropeFall2020BIO_EUROPE_43; Part B will focus on investigating efficacy in a further 100 treatment naïve patients with a placebo-controlled arm. How can cancer patients improve their outcomes with microbiome-based therapeutics? Oncology (MRx0518)
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Live biotherapeutic MRx0518 as a modulator of immune responses in intestinal tissue and breast tumor microenvironment (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1243; Our preclinical studies demonstrate that the ability of oral MRx0518 to reduce tumor growth in the EMT-6 syngeneic model of breast cancer is mainly related to changes in innate (increase in NK cells, upregulation of tumour TLR5 expression) and adaptive (increase of ratio CD8+ T cells/FoxP3+ regulatory T cells) immune responses locally in the gut but also in the distal tumour microenvironment. In this context, MRx0518 monotherapy and combination with immune checkpoint inhibitors is a promising therapeutic approach for enhancing antitumor immune responses.
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