{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2019"],"data_sharing_plan":["IPD Sharing (as of February 2023): No"],"condition":["Locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or dMMR CRC who are eligible for anti-PD-1 1st line of treatment","Solid Tumor, Adult","Neoplasms","Metastatic colorectal cancer","Irresecable o metastásico localmente avanzado, inestabilidad de microsatélites alta (MSI-H) o dMMR CRC que son elegibles para la primera línea de tratamiento anti-PD-1"],"disease":["Metastatic Colorectal Cancer","Irresecable O Metastásico Localmente Avanzado, Inestabilidad De Microsatélites Alta (msi-h) O Dmmr Crc Que Son Elegibles Para La Primera Línea De Tratamiento Anti-pd-1","Solid Tumor, Adult","Locally Advanced Unresectable Or Metastatic, Microsatellite Instability High (msi-h) Or Dmmr Crc Who Are Eligible For Anti-pd-1 1st Line Of Treatment","Neoplasms"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2312569"],"location":["United States","Czechia","Italy","Spain"],"study_start_month":["10"],"keyword":["Nous-209"],"repository":["ECRIN MDR"],"study_status":["Recruiting"],"additional_accession":[]},"is_claimable":false,"name":"Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors","description":"Ref: Protocol v7.0, dated 23Mar2022. NOUS-209-01 is a multicenter, open-label, multiple cohorts, clinical study, designed to evaluate safety, tolerability, and immunogenicity, and to detect any preliminary evidence of anti-tumor activity of Nous-209 genetic polyvalent vaccine plus pembrolizumab combination therapy in adult subjects with unresectable or metastatic deficient mismatch repair (dMMR) or MSI-H CRC, gastric, or gastro-esophageal junction (G-E junction) tumors. Nous-209 is based on a heterologous prime/boost regimen composed of the Great Ape Adenovirus GAd20-209-FSP used for priming and Modified Vaccinia virus Ankara MVA-209-FSP used for boosting. The Phase I portion of the study is a first-in-human (FIH) clinical study with a primary objective to elucidate the safety and tolerability of Nous-209 in addition to establishing the recommended Phase 2 dose (RP2D), whereas the Phase II was introduced to assess efficacy as the primary objective.","dates":{"creation":"2019-10-15"},"accession":"2312569","cross_references":{"ClinicalTrials___gov":["NCT04041310"],"EU Clinical Trials Register":["2021-002823-40"]}}