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Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases

NCT07359456 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-05-19

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the superiority of ivonescimab combined with FOLFIRI over FOLFIRI + bevacizumab as second-line treatment of non resectable pMMR/MSS BRAFwt mCRC patients without liver metastases in terms of PFS. The main questions it aims to answer are:

Does FOLFIRI + ivonescimab improve progression-free survival compared to FOLFIRI + bevacizumab?

Participants will:

Take FOLFIRI + ivonescimab or FOLFIRI + bevacizumab every 2 weeks for a maximum of 24 months Visit the clinic once every 2 weeks for checkups and tests, and have imaging done every 8 weeks Complete some quality of life questionnaires every 8 weeks

Conditions

Interventions

DRUG

Ivonescimab

Ivonescimab 20 mg/kg by intravenous infusion (IV) once every 2 weeks (Q2W)

DRUG

Bevacizumab

Bevacizumab 5 mg/kg by intravenous infusion (IV) once every 2 weeks (Q2W)

DRUG

FOLFIRI Protocol

FOLFIRI chemotherapy (irinotecan 180 mg/m2 IV, folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m2 as a 46 hour continuous IV infusion), every two weeks

Sponsors & Collaborators

  • Summit Therapeutics

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-08-31
Completion
2033-08-31

Countries

  • France

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 NCT07359456 on ClinicalTrials.gov