Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT04513951
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2020-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients
Sponsor:
Gruppo Oncologico del Nord-Ovest
Organization:
Study Overview
Official Title:
Phase II Study of AVELUMAB and CETUXIMAB and Modified FOLFOXIRI as Initial Therapy for RAS Wild-type Unresectable Metastatic Colorectal Cancer Patients
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVETRIC
Brief Summary:
The aim of this study is to evaluate the efficacy of mFOLFOXIRI plus cetuximab and avelumab as first line treatment of patients with initially unresectable and previously untreated RAS wild-type metastatic colorectal cancer (mCRC), in terms of Progression-free Survival.
Detailed Description:
This is a prospective, open-label, multicentric phase II single-arm trial in which patients with initially unresectable and previously untreated RAS wild-type mCRC will receive induction treatment with mFOLFOXIRI plus cetuximab and avelumab up to 12 cycles followed by maintenance with 5-FU/LV plus cetuximab plus avelumab until disease progression, unacceptable toxicity or patient's refusal. The second- and subsequent lines of treatment will be at investigators' choice.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: