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A multicenter randomized phase 2 study to compare the efficacy and safety of avelumab versus standard second line treatment, in patients with metastatic colorectal cancer (MMR) after first line treatment progression.

ABSTRACT: Primary objectives: Compare between the two treatment arms (arm A: 2nd line chemotherapy, arm B: avelumab) progression-free survival by central review (RECIST 1.1 for Arm A and iRECIST for arm B) Primary endpoints: The primary endpoint is radiographic progression-free survival (PFS). The progression will be assessed by central review according to the criteria RECIST v1.1 in arm A and according to the criteria irRECIST in arm B.PFS is defined as the time between the date of randomization and the date of the first radiological progression or the date of death (for whatever reason). Patients living without radiological progression will be censured on the date of their latest x-ray.

DISEASE(S): Colorectal Metastatic Cancer With Microsatellite Instability (msi)

PROVIDER: 2536396 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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