{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Nelson BE"],"funding":["Foundation for the National Institutes of Health","Foundation for the National Institutes of Health (FNIH)","NCI NIH HHS"],"pagination":["3864-3875"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12434394"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["31(18)"],"pubmed_abstract":["<h4>Purpose</h4>Intratumoral injection of Clostridium novyi-nontoxic (C. novyi-NT), lacking alpha-toxin, germinates and subsequently replicates in the tumor hypoxic regions, causing cell lysis and inflammation. This phase Ib study investigated the safety and synergistic effects of pembrolizumab and C. novyi-NT in advanced solid tumors.<h4>Patients and methods</h4>Patients with injectable solid tumors received one intratumoral C. novyi-NT injection (day 8) across four dose cohorts (3 × 104 to 100 × 104 spores) with pembrolizumab (200 mg intravenously every 3 weeks, day 0-24 months). Sixteen patients were enrolled with a median age of 62.5 years, and the most common tumor types were breast cancer and melanoma.<h4>Results</h4>The combination therapy demonstrated a manageable safety profile, w"],"journal":["Clinical cancer research : an official journal of the American Association for Cancer Research"],"pubmed_title":["Phase Ib Study of Pembrolizumab in Combination with Intratumoral Injection of Clostridium novyi-NT in Patients with Advanced Solid Tumors."],"pmcid":["PMC12434394"],"funding_grant_id":["P30CA016672","P30 CA016672"],"pubmed_authors":["Murthy R","Fu S","Tung D","Khazaie K","Singh MP","Kreider BL","Piha-Paul SA","Janku F","Damodaran S","Pezeshki A","Carapanceanu N","Tsimberidou AM","Conley AP","Nelson BE","Leontovich AA","Amaria RN","Carapanceanu V","Karp DD","Hong DS","Rodon J","Varterasian M","Naing A","Raghav KPS","Dumbrava EE","Sheth RA"],"additional_accession":[]},"is_claimable":false,"name":"Phase Ib Study of Pembrolizumab in Combination with Intratumoral Injection of Clostridium novyi-NT in Patients with Advanced Solid Tumors.","description":"<h4>Purpose</h4>Intratumoral injection of Clostridium novyi-nontoxic (C. novyi-NT), lacking alpha-toxin, germinates and subsequently replicates in the tumor hypoxic regions, causing cell lysis and inflammation. This phase Ib study investigated the safety and synergistic effects of pembrolizumab and C. novyi-NT in advanced solid tumors.<h4>Patients and methods</h4>Patients with injectable solid tumors received one intratumoral C. novyi-NT injection (day 8) across four dose cohorts (3 × 104 to 100 × 104 spores) with pembrolizumab (200 mg intravenously every 3 weeks, day 0-24 months). Sixteen patients were enrolled with a median age of 62.5 years, and the most common tumor types were breast cancer and melanoma.<h4>Results</h4>The combination therapy demonstrated a manageable safety profile, w","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Sep","modification":"2026-06-03T03:02:16.571Z","creation":"2026-04-23T03:13:52.854Z"},"accession":"S-EPMC12434394","cross_references":{"pubmed":["40643985"],"doi":["10.1158/1078-0432.CCR-24-3952"]}}