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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04590963 | Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 370 | — | — | Oct 2, 2020 | Sep 24, 2026 | Jun 1, 2026 | 127 | United States, Argentina +21 |
The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and hazard ratio (HR) and confidence intervals (CIs) from a stratified Cox proportional hazards model. Analyses were stratified on World Health Organization/ Eastern Cooperative Oncology Group performance status (WHO/ECOG PS) (0 or 1) and number of prior lines of therapy in recurrent or metastatic (R/M) setting (1 or 2).
| Arm | Type | Description |
|---|---|---|
| Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | EXPERIMENTAL | Participants will receive intravenous (IV) monalizumab 750 mg every two weeks (Q2W) and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 every one week (Q1W) until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| Placebo Q2W + Cetuximab 400 mg/m^2 | ACTIVE_COMPARATOR | Participants will receieve IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| Name | Type | Description |
|---|---|---|
| Monalizumab | DRUG | Participants will receive IV infusion of monalizumab as stated in arm description. |
| Cetuximab | DRUG | Participants will receive IV infusion of cetuximab as stated in arm description. |
| Placebo | OTHER | Participants will receive IV infusion of placebo as stated in arm description. |
Inclusion Criteria: * Are aged 18 years and over * Recurrent or metastatic squamous cell carcinoma of the SCCHN, oral cavity, oropharynx, hypopharynx, or larynx which has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy * Received prior treatment using...