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.
Primary Objective:
To compare the progression-free survival (PFS) as assessed by blinded Independent Radiological Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, of ivonescimab in combination with modified 5-FU, oxaliplatin, and leucovorin (mFOLFOX6) to bevacizumab in combination with mFOLFOX6.
Secondary Objectives:
- To compare the overall survival (OS) of ivonescimab in combination with mFOLFOX6 to bevacizumab in combination with mFOLFOX6.
- To compare objective response rate (ORR) and duration of response (DOR) as assessed by blinded IRRC based on RECIST v1.1, of ivonescimab in combination with mFOLFOX6 to bevacizumab plus mFOLFOX6.
- To compare the safety and tolerability of ivonescimab in combination with mFOLFOX6 to bevacizumab in combination with mFOLFOX6.
- To evaluate the pharmacokinetic (PK) profile of ivonescimab in combination with mFOLFOX6.
- To evaluate the immunogenicity of ivonescimab in combination with mFOLFOX6.
FOLFOX
Ivonescimab
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Monmouth Medical Center
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Somerset
- Rutgers University
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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