ecrin-mdr-crcClinical2019IPD Sharing (as of February 2023): NoLocally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or dMMR CRC who are eligible for anti-PD-1 1st line of treatmentSolid Tumor, AdultNeoplasmsMetastatic colorectal cancerIrresecable o metastásico localmente avanzado, inestabilidad de microsatélites alta (MSI-H) o dMMR CRC que son elegibles para la primera línea de tratamiento anti-PD-1Metastatic Colorectal CancerIrresecable O Metastásico Localmente Avanzado, Inestabilidad De Microsatélites Alta (msi-h) O Dmmr Crc Que Son Elegibles Para La Primera Línea De Tratamiento Anti-pd-1Solid Tumor, AdultLocally Advanced Unresectable Or Metastatic, Microsatellite Instability High (msi-h) Or Dmmr Crc Who Are Eligible For Anti-pd-1 1st Line Of TreatmentNeoplasmsInterventionalhttps://newmdr.ecrin.org/Study/2312569United StatesCzechiaItalySpain10Nous-209ECRIN MDRRecruitingfalseNous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid TumorsRef: 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.2019-10-152312569NCT040413102021-002823-40