Avelumab Plus Autologous Dendritic Cell Vaccine in Pre-treated Metastatic Colorectal Cancer Patients

Phase 1/2 Completed 28 enrolled Grupo Espanol Multidisciplinario del Cancer Digestivo

NaSingle-groupOpen-labelTreatment

Summary

Single arm Phase I/II multicentric open labeled, with translational sub-study, of avelumab plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS) metastatic colorectal cancer patients..

Timeline

Start: 2018-03-12
Primary completion: 2019-06-30
Completion: 2020-10-05

Outcome

Missed primary endpoint

paper An interim analysis (Simon design first-stage) recommended early termination because only 2/19 (11%) patients were disease free at 6 months. PMID 36083313 ↗

Publications

Espanol-Rego M, Fernandez-Martos C, Elez E, Foguet C, Pedrosa L, Rodriguez N, Ruiz-Casado A, Pineda E, Cid J, Cabezon R, Oliveres H, Lozano M, Gines A, Garcia-Criado A, Ayuso JR, Pages M, Cuatrecasas M, Torres F, Thomson T, Cascante M, Benitez-Ribas D, Maurel J. A Phase I-II multicenter trial with Avelumab plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS) metastatic colorectal cancer patients; GEMCAD 1602 study. Cancer Immunol Immunother. 2023 Apr;72(4):827-840. doi: 10.1007/s00262-022-03283-5. Epub 2022 Sep 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avelumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	autologous dendritic cells	Cell therapy	1e+07 cells	Other