NCT05291156

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

CAVE-2 (Cetuximab-AVElumab) mCRC: A Phase II Randomized Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy in Pre-treated RAS/BRAF Wild Type Metastatic Colorectal Cancer Patients.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 173 (estimated)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a non-profit phase II, open-label, randomized clinical study of the combination of avelumab plus cetuximab as rechallenge strategy in pre-treated RAS, BRAF wild type metastatic colorectal cancer patients treated in first line with chemotherapy in combination with cetuximab and have had a clinical benefit (complete or partial response) from treatment. 173 patients will be randomized (2:1) as follows: cetuximab + avelumab (115 patients) or cetuximab only (58 patients). For each patient, before treatment, a blood sample will be obtained and analyzed for circulating free tumorDNA, to identify RAS/BRAF wild type patient to be enrolled. The same procedure will be performed at progression of the disease. Treatment will continue until: * disease progression. * significant clinical deterioration * any criterion for withdrawal from the trial or trial drug is fulfilled * treatment may continue past the initial determination of disease progression according to RECIST 1.1. if the subject's performance status has remained stable, and if in the opinion of the Investigator, the subject will benefit from continued treatment and if other criteria are fulfilled as outlined in the protocol, that is, no new symptoms or worsening of existing symptoms and no decrease in performance score.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab	Cetuximab will be administered at 1st dose at 400 mg/m2 by i.v. infusion over 120 minutes. The 2nd dose and subsequent doses will be performed at 250 mg/ m2 by i.v. infusion over 60 minutes, every week.
DRUG	Avelumab	Avelumab will be administered as a 1-hour IV infusion at flat dose of 800 mg every 2-week treatment cycle.

Timeline

• Start date: 2022-07-21
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-03-22
• Last updated: 2024-02-01

Locations

24 sites across 1 country: Italy