drugset / Trial / NCT05291156

CAVE-2 GOIM Study: a Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy

NCT05291156 ↗

Phase 2 Unknown 173 enrolled University of Campania Luigi Vanvitelli
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a non-profit phase II, randomized clinical study of the combination of avelumab plus cetuximab as rechallenge strategy, compared to cetuximab alone, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in first line with chemotherapy in combination with cetuximab and have had a clinical benefit (complete or partial response) from treatment.

Timeline

Start
2022-07-21
Primary completion
2025-07-01
Completion
2025-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Avelumab Monoclonal antibody 800 mg Intravenous
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous

Indications