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
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)
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.
Arms & interventions
- DrugDrug: Ivonescimab Injection
Subjects will receive Ivonescimab Plus mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) via intravenous infusion (IV) Q2W, up to 8 cycles. Afterward, Ivonescimab plus Leucovorin and 5-Fluorouracil will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) for up to 2 years.
- DrugDrug: Bevacizumab Injection
Subjects will receive bevacizumab Plus mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) via intravenous infusion (IV) Q2W, up to 8 cycles in treatment periods per the randomization schedule. Afterward, bevacizumab Plus 5-FU and Leucovorin will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) up to 2 years.
Outcome measures
Primary
PFS by IRRC based on RECIST v1.1
Progression-free survival (PFS) assessed by IRRC per RECIST v1.1
Time frame: Up to approximately 2.5 years
Secondary
Overall Survival (OS) in the population
Time frame: Up to approximately 4 years
ORR
Time frame: Up to approximately 2.5 years
Adverse Events (AE)
Time frame: Up to approximately 4 years
DoR
Time frame: up to approximately 2.5 years
Eligibility criteria
Study locations (58)
Clinical Study Site
Goodyear, Arizona, 85338
Clinical Study Site
Beverly Hills, California, 90211
Clinical Study Site
Beverly Hills, California, 90212
Clinical Study Site
Cerritos, California, 90703
Clinical Study Site
Corona, California, 92882
Clinical Study Site
Duarte, California, 91010
Clinical Study Site
Fountain Valley, California, 92708
Clinical Study Site
Huntington Beach, California, 92648
Clinical Study Site
Irvine, California, 92612
Clinical Study Site
Irvine, California, 92618
Clinical Study Site
Los Angeles, California, 90027
Clinical Study Site
Los Angeles, California, 90067
Clinical Study Site
Los Angeles, California, 90404
Clinical Study Site
Murrieta, California, 92562
Clinical Study Site
Orange, California, 92868
Clinical Study Site
Pasadena, California, 91030
Clinical Study Site
Torrance, California, 90503
Clinical Study Site
Upland, California, 91786
Clinical Study Site
West Hollywood, California, 90048
Clinical Study Site
Hartford, Connecticut, 06106
Clinical Study Site
New Haven, Connecticut, 06520-8028
Clinical Study Site
Norwich, Connecticut, 06360
Clinical Study Site
Hialeah, Florida, 33013
Clinical Study Site
Miami, Florida, 33176
Clinical Study Site
Orlando, Florida, 32806
Clinical Study Site
Plantation, Florida, 33322
Clinical Study Site
Port Saint Lucie, Florida, 34952
Clinical Study Site
Tamarac, Florida, 33321
Clinical Study Site
Newnan, Georgia, 30265
Clinical Study Site
Chicago, Illinois, 60611
Clinical Study Site
Elmhurst, Illinois, 60540
Clinical Study Site
O'Fallon, Illinois, 62269
Clinical Study Site
Fort Wayne, Indiana, 46804
Clinical Study Site
Indianapolis, Indiana, 46202
Clinical Study Site
Edgewood, Kentucky, 41017
Clinical Study Site
Saint Louis Park, Minnesota, 55426
Clinical Study Site
Billings, Montana, 59102
Clinical Study Site
Lincoln, Nebraska, 68506
Clinical Study Site
New Brunswick, New Jersey, 08901
Clinical Study Site
Mineola, New York, 11501
Clinical Study Site
New York, New York, 10016
Clinical Study Site
The Bronx, New York, 10461
Clinical Study Site
Akron, Ohio, 44032
Clinical Study Site
Canton, Ohio, 44703
Clinical Study Site
Cincinnati, Ohio, 45219
Clinical Study Site
Cincinnati, Ohio, 45220
Clinical Study Site
Cleveland, Ohio, 44111
Clinical Study Site
Cleveland, Ohio, 44195
Clinical Study Site
Mayfield Heights, Ohio, 44124
Clinical Study Site
Philadelphia, Pennsylvania, 19111
Clinical Study Site
Philadelphia, Pennsylvania, 19140
Clinical Study Site
Hermitage, Tennessee, 37129
Clinical Study Site
Fort Worth, Texas, 76104
Clinical Study Site
Salt Lake City, Utah, 84106
Clinical Study Site
Charlottesville, Virginia, 22908
Clinical Study Site
Spokane, Washington, 99208
Clinical Study Site
Tacoma, Washington, 98405
Clinical Study Site
Charleston, West Virginia, 25304