RecruitingPhase 3

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

United States600 participantsStarted 2025-11-18

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

PFS by IRRC based on RECIST v1.1

Timeframe: Up to approximately 2.5 years

Trial details

NCT IDNCT07228832

SponsorSummit Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-05-31

Contact for this trial

Nindhana Paranthaman, MD

1-833-256-0522 medicalaffairs@summitplc.com

View on ClinicalTrials.gov More Metastatic Colorectal Cancer (CRC) trials