Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07228832 | Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer | PHASE3 | RECRUITING | 600 | — | — | Nov 18, 2025 | Nov 30, 2029 | May 5, 2026 | 76 | United States, Canada +3 |
Progression-free survival (PFS) assessed by IRRC per RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Arm A: Ivonescimab in combination with mFOLFOX6 | EXPERIMENTAL | Subjects will receive Ivonescimab Plus mFOLFOX6 via intravenous infusion (IV) Q2W, up to 8 cycles. Afterward, Ivonescimab plus Leucovorin and 5-FU will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) up to 2 years. |
| Arm B: Bevacizumab in combination with mFOLFOX6 | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Drug: Ivonescimab Injection | DRUG | 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. |
| Drug: Bevacizumab Injection | DRUG | 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. |
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. Micros...