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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07264075 | Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN | PHASE3 | NOT YET_RECRUITING | 780 | — | — | Apr 1, 2026 | May 1, 2030 | Apr 2, 2026 | - | — |
the time from the date of randomization to the date of death from any cause. Patients still alive at the time of analysis will be censored at the date of their last known alive date
| Arm | Type | Description |
|---|---|---|
| Bras A: Ivonescimab | EXPERIMENTAL | Ivonescimab (10 mg/kg iv, 60 min ± 10 min infusion, Q3W) |
| Bras B: Ivonescimab - Ligufalimab | EXPERIMENTAL | Ivonescimab (10 mg/kg iv, 60 min ± 10 min infusion, Q3W), and ligufalimab (45 mg/kg iv, 120 min ± 15 min infusion, Q3W). |
| Bras C: Pembrolizumab | ACTIVE_COMPARATOR | Pembrolizumab (200 mg iv, 60 min ± 10 min infusion, Q3W). |
| Name | Type | Description |
|---|---|---|
| Ivonescimab 10 mg/kg | DRUG | Ivonescimab is a humanized immunoglobulin (Ig) G1 monoclonal antibody (mAb) being investigated as a cancer immunotherapy agent. Ivonescimab binds to human VEGF-A which is involved in tumor angiogenesis, and to human PD-1 that is a cell surface receptor expressed primarily on activated T cells and acts to inhibit T cell activation. |
| Ligufalimab | DRUG | AK117 is a humanized IgG4 mAb being investigated as a cancer immunotherapy agent |
| Pembrolizumab (KEYTRUDA ®) | DRUG | Pembrolizumab is a humanized monoclonal antibody (IgG4 kappa isotype with stabilizing sequence alteration in the Fc region) against PD-1 (programmed cell death-1), produced in Chinese hamster ovary cells by recombinant DNA technology. |
Inclusion Criteria: 1. Patient capable of voluntary giving her/his written informed consent. 2. Age ≥ 18 and \< 80 years old at the time of enrolment. 3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1. 4. Expected survival ≥ 6 months at randomization. 5. Patient...