NCT03152565

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

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Avelumab	Autologous Dendritic Cells vaccine: A dose of ADC at days 1, 14, 28, 42 and 56 (total of 5 doses), and thereafter every 6 months until disease progression (maximum of 6 additional doses) or unacceptable toxicity. Avelumab will be administered intravenously at a dose of 10 mg per kilogram of body weight, every 14 days until disease progression or unacceptable toxicity.

Timeline

• Start date: 2018-03-12
• Primary completion: 2019-06-30
• Completion: 2020-10-05
• First posted: 2017-05-15
• Last updated: 2020-10-06

Locations

8 sites across 1 country: Spain