NCT06011772

EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer

A Phase 0 Study of EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the immunogenicity of the CIMAvaxEGF® vaccine (that is, its effectiveness in inducing an anti-tumor immune response) in patients with metastatic KRAS/NRAS/BRAF wild-type gene colorectal cancer, when given in combination with standard therapies used in the treatment of advanced colorectal cancer.

Detailed description

Primary Objective \- Determine the immunogenicity of CIMAvax in patients with metastatic, KRAS/NRAS/BRAF wild type CRC in combination with Chemotherapy plus appropriate biologic agent in 1st or 2nd/3rd line setting and chemotherapy plus anti-EGFR therapy in 2nd/3rd line setting.

Conditions

• Colo-rectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine	Given IM
DRUG	Leucovorin	Given IV
DRUG	Oxaliplatin	Given IV
DRUG	Fluorouracil	Given IV
BIOLOGICAL	Bevacizumab	Given IV
DRUG	Irinotecan	Given IV
BIOLOGICAL	Cetuximab	Given IV
PROCEDURE	Metastasectomy	Undergo metastasectomy
PROCEDURE	Biospecimen collection	Undergo collection of blood samples
PROCEDURE	Computed Tomography	Undergo CT
BIOLOGICAL	Panitumumbab	Given IV

Timeline

• Start date: 2023-12-18
• Primary completion: 2026-02-05
• Completion: 2026-12-04
• First posted: 2023-08-25
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study