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

Recruiting · NCT07228832 · Interventional (participants receive a specific treatment) · Lead sponsor: Summit Therapeutics

View the official record on ClinicalTrials.gov →

Colorectal cancer

Interventions studied

Drug: Bevacizumab InjectionDrug: Ivonescimab Injection

What this trial is about

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 take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

60 locations listed across 33 US states.

Clinical Study Site - Mobile, Alabama, United States
Clinical Study Site - Tuscaloosa, Alabama, United States
Clinical Study Site - Goodyear, Arizona, United States
Clinical Study Site - Beverly Hills, California, United States
Clinical Study Site - Beverly Hills, California, United States
Clinical Study Site - Cerritos, California, United States
Clinical Study Site - Corona, California, United States
Clinical Study Site - Duarte, California, United States
Clinical Study Site - Fountain Valley, California, United States
Clinical Study Site - Huntington Beach, California, United States
Clinical Study Site - Irvine, California, United States
Clinical Study Site - Irvine, California, United States
Clinical Study Site - Los Angeles, California, United States
Clinical Study Site - Los Angeles, California, United States
Clinical Study Site - Los Angeles, California, United States
Clinical Study Site - Murrieta, California, United States
Clinical Study Site - Oakland, California, United States
Clinical Study Site - Orange, California, United States
Clinical Study Site - Pasadena, California, United States
Clinical Study Site - Roseville, California, United States
Clinical Study Site - San Francisco, California, United States
Clinical Study Site - Santa Clara, California, United States
Clinical Study Site - Stanford, California, United States
Clinical Study Site - Torrance, California, United States
Clinical Study Site - Upland, California, United States
Clinical Study Site - Vallejo, California, United States
Clinical Study Site - West Hollywood, California, United States
Clinical Study Site - Hartford, Connecticut, United States
Clinical Study Site - New Haven, Connecticut, United States
Clinical Study Site - Norwich, Connecticut, United States
Clinical Study Site - Newark, Delaware, United States
Clinical Study Site - Hialeah, Florida, United States
Clinical Study Site - Miami, Florida, United States
Clinical Study Site - Miami Beach, Florida, United States
Clinical Study Site - Ocala, Florida, United States
Clinical Study Site - Orlando, Florida, United States
Clinical Study Site - Plantation, Florida, United States
Clinical Study Site - Port Saint Lucie, Florida, United States
Clinical Study Site - St. Petersburg, Florida, United States
Clinical Study Site - Tamarac, Florida, United States
Clinical Study Site - Atlanta, Georgia, United States
Clinical Study Site - Atlanta, Georgia, United States
Clinical Study Site - Newnan, Georgia, United States
Clinical Study Site - Chicago, Illinois, United States
Clinical Study Site - Elmhurst, Illinois, United States
Clinical Study Site - O'Fallon, Illinois, United States
Clinical Study Site - Fort Wayne, Indiana, United States
Clinical Study Site - Indianapolis, Indiana, United States
Clinical Study Site - Westwood, Kansas, United States
Clinical Study Site - Edgewood, Kentucky, United States
Clinical Study Site - New Orleans, Louisiana, United States
Clinical Study Site - Baltimore, Maryland, United States
Clinical Study Site - Detroit, Michigan, United States
Clinical Study Site - Saint Louis Park, Minnesota, United States
Clinical Study Site - Springfield, Missouri, United States
Clinical Study Site - Billings, Montana, United States
Clinical Study Site - Lincoln, Nebraska, United States
Clinical Study Site - Lebanon, New Hampshire, United States
Clinical Study Site - New Brunswick, New Jersey, United States
Clinical Study Site - Mineola, New York, United States

Showing 60 of 166 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →