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NCT07228832 | RECRUITING | Metastatic Colorectal Cancer (CRC)

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

Summit Therapeutics

Brief Summary:

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)

Condition or disease

Metastatic Colorectal Cancer (CRC)

Intervention/treatment

Drug: Ivonescimab Injection

Drug: Bevacizumab Injection

Phase

PHASE3

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 600 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer
Actual Study Start Date : 2025-11-15
Estimated Primary Completion Date : 2028-05-31
Estimated Study Completion Date : 2029-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

Location Details

NCT07228832

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Locations

RECRUITING

United States, California

Clinical Study Site

Los Angeles, California, United States, 90067

RECRUITING

United States, California

Clinical Study Site

Murrieta, California, United States, 92562

RECRUITING

United States, Nebraska

Clinical Study Site

Lincoln, Nebraska, United States, 68506

RECRUITING

United States, Washington

Clinical Study Site

Spokane, Washington, United States, 99208