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

NCT07228832

RecruitingPhase 3

Sponsor: Summit Therapeutics

Conditions: Metastatic Colorectal Cancer (CRC)

Interventions: Drug: Ivonescimab Injection, Drug: Bevacizumab Injection

Countries: United States, Belgium, Canada, Czechia, France, Germany, Italy, Japan

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)

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (166)
  • Mobile, Alabama, United States
  • Tuscaloosa, Alabama, United States
  • Goodyear, Arizona, United States
  • Beverly Hills, California, United States
  • Beverly Hills, California, United States
  • Cerritos, California, United States
  • Corona, California, United States
  • Duarte, California, United States
  • Fountain Valley, California, United States
  • Huntington Beach, California, United States
  • Irvine, California, United States
  • Irvine, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Murrieta, California, United States
  • Oakland, California, United States
  • Orange, California, United States
  • Pasadena, California, United States
  • Roseville, California, United States
  • San Francisco, California, United States
  • Santa Clara, California, United States
  • Stanford, California, United States
  • Torrance, California, United States
  • Upland, California, United States
  • Vallejo, California, United States
  • West Hollywood, California, United States
  • Hartford, Connecticut, United States
  • New Haven, Connecticut, United States
  • Norwich, Connecticut, United States
  • + 136 more on CT.gov