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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02643550 | Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | PHASE1 | COMPLETED | 143 | — | — | Dec 1, 2015 | Mar 28, 2023 | May 12, 2023 | 18 | United States, France |
To assess the occurrence of Drug Limited Toxicities (DLTs)
rate of patients in complete or partial response according to RECIST 1.1.
| Arm | Type | Description |
|---|---|---|
| Dose escalation | EXPERIMENTAL | Dose escalation of monalizumab in combination with cetuximab |
| Expansion cohort 1 | EXPERIMENTAL | monalizumab + cetuximab expansion cohort |
| Expansion cohort 2 | EXPERIMENTAL | monalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers |
| Expansion cohort 3 | EXPERIMENTAL | monalizumab + cetuximab + anti-PD(L)1 |
| Name | Type | Description |
|---|---|---|
| Monalizumab | BIOLOGICAL | - |
| Cetuximab | BIOLOGICAL | - |
| Anti-PD(L)1 | BIOLOGICAL | - |
Main Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis, glottis, subglottis) or oral cavity. 3. Recurrent or metastatic disease, documented by ...