NCT04561336

Avelumab Plus Cetuximab in Pre-treated RAS Wild Type Metastatic Colorectal Cancer

CAVE (Cetuximab-AVElumab) mCRC: A Single Arm Phase II Clinical Study of the Combination of Avelumab Plus Cetuximab in Pre-treated RAS Wild Type Metastatic Colorectal Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• 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, open-label, single-arm study of cetuximab plus avelumab in patients with RAS WT mCRC treated in first line with chemotherapy in combination with an anti- EGFR drug that have had a clinical benefit (complete or partial response) from treatment.

Detailed description

The primary objective of the study is to evaluate the efficacy (OS) of avelumab and cetuximab combined in pre-treated RAS wild type metastatic colorectal cancer patients. Tumor measurements by computed tomography (CT) scan or magnetic resonance imaging (MRI) will be performed every 8 weeks from the beginning of treatment to determine response to treatment. Response will be evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Treatment will continue until disease progression, significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled. Treatment may continue past the initial determination of disease progression per 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.

Conditions

• Metastatic Colorectal Cancer
• RAS Wild Type

Interventions

Type	Name	Description
DRUG	Avelumab	avelumab in combination with cetuximab
DRUG	Cetuximab	avelumab in combination with cetuximab

Timeline

• Start date: 2018-08-10
• Primary completion: 2021-11-14
• Completion: 2021-11-14
• First posted: 2020-09-23
• Last updated: 2022-05-05

Locations

1 site across 1 country: Italy