Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

Sponsor: Summit Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT07228832

This Phase III trial evaluates Ivonescimab with mFOLFOX6 against Bevacizumab with mFOLFOX6 in 600 patients with metastatic colorectal cancer. Eligible participants have an ECOG score of 0-1, life expectancy ≥ 6 months, confirmed metastatic CRC, no prior systemic therapy, and at least one measurable lesion. Treatments involve IV infusions every two weeks, with maintenance for up to two years.

Patient Parameters

Program Overview

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)

Description

This trial will be performed as a phase 3, randomized, active-controlled, double-blind, multiregional study comparing Ivonescimab in combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in combination with mFOLFOX6 in patients with metastatic colorectal cancer who have not previously received systemic therapy for metastatic disease. Approximately 600 patients will be randomly assigned to the 2 treatment groups in a 1:1 ratio. Each enrolled subject will receive an intravenous infusion of the Ivonescimab/Bevacizumab Plus mFOLFOX6 (Q2W, up to 8 cycles) in treatment periods per the randomization schedule. Afterward, Ivonescimab/ Bevacizumab Plus 5-Fluorouracil and Leucovorin will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  1. ECOG performance status score of 0 or 1
  2. Expected life expectancy ≥ 6 months
  3. Patients with histologically or cytologically confirmed metastatic CRC
  4. No prior systemic therapy for metastatic CRC
  5. At least 1 measurable noncerebral lesion

Exclusion Criteria

  1. Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
  2. Known BRAF V600E mutant status
  3. Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction
  4. Ascites requiring paracentesis within last 30 days
  5. Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer
  6. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  7. Resectable disease

Locations

FACILITYZIPCITYSTATE
Clinical Study Site90067Los AngelesCalifornia
Clinical Study Site92562MurrietaCalifornia
Clinical Study Site68506LincolnNebraska
Clinical Study Site99208SpokaneWashington

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