Spots Global Cancer Trial Database for Avelumab Plus Autologous Dendritic Cell Vaccine in Pre-treated Metastatic Colorectal Cancer Patients
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Trial Identification
Brief Title: Avelumab Plus Autologous Dendritic Cell Vaccine in Pre-treated Metastatic Colorectal Cancer Patients
Official Title: A Single Arm Phase I-II Multicenter Trial With Avelumab Plus Autologous Dendritic Cell Vaccine to Determine Safety and Preliminary Efficacy of the Combination in Pre-treated Mismatch Repair-proficient (MSS) Metastatic Colorectal Cancer Patients.
Study ID: NCT03152565
Conditions
Interventions
Study Description
Brief 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..
Detailed Description: This 2-phases study will first evaluate two different doses/schema of avelumab plus autologous dendritic cell vaccine (ADC) vaccines, in intention to define which dose is effective without hampering safety. Second phase will consist in an standard analysis of efficacy and progression free survival. It is expected that 4 Spanish Sites will include patients in phase I and 8 Spanish Centers will include patients in the phase II of the study
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Clínic Barcelona, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Madrid, , Spain
Hospital Universitario y Politécnico La Fe, Valencia, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
Contact Details
Name: Joan Maurel Santasusana, M.D.
Affiliation: Hospital Clinic of Barcelona
Role: PRINCIPAL_INVESTIGATOR
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