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

NCT05291156 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2024-02-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Fortunato Ciardiello · A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05291156 on ClinicalTrials.gov