Metastatic Colorectal Cancer
Conditions
Interventions
Patients randomly assigned in a 1:1 ratio to the 2 treatment groups:
- Group A: ivonescimab (20 mg/kg, every 2 weeks) + mFOLFOX6 (on Days 1, 2 of a 2-week treatment cycle) for 8 cycles followed by mai
Sponsors
Paranthaman Nindhana
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An Eastern Cooperative Oncology Organization Group (ECOG) performance status score of 0 or 1. 2. Expected life expectancy is at least 6 months. 3. Patients with histologically or cytologically confirmed metastatic CRC, not amenable to curative resection. 4. No prior systemic therapy for metastatic CRC. 5. At least one measurable tumor lesion according to RECIST v1.1 that is amenable to repeated accurate measurements.
Exclusion criteria
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, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and any other therapy based on the mechanism of action of tumor immunity or angiogenesis. 6. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea). 7. Resectable oligometastastic only disease, with multidisciplinary plan for complete resection of all disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) as assessed by blinded Independent Radiological Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| - OS - ORR and DOR as assessed by IRRC based on RECIST v1.1 - Safety assessment: incidence and severity of adverse events (AEs), clinically significant abnormal laboratory test results. - Pharmacokinetic profile: Serum concentrations of ivonescimab in patients at different time points after ivonescimab administration. - Immunogenicity assessment: Number and percentage of patients with detectable anti-ivonescimab antibody. | — |
Countries
Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Serbia, Spain, United Kingdom, USA
Contacts
Public ContactHironori Taira
Syneos Health Japan K.K.
Outcome results
None listed