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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04975152 | Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma | PHASE1 | RECRUITING | 36 | — | — | Oct 22, 2021 | Mar 1, 2028 | May 27, 2026 | 1 | United States |
Number of participants with adverse events after receiving at least one dose of cemiplimab
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant Cemiplimab Treatment | EXPERIMENTAL | Participants will receive cemiplimab 350 mg IV at least 3 weeks prior to surgical resection. After surgery they will continue to receive 350 mg cemiplimab every 3 weeks for up to 8 additional doses. |
| Name | Type | Description |
|---|---|---|
| Cemiplimab-Rwlc | DRUG | Flat dose of cemiplimab-rwlc 350 mg IV every 3 weeks, up to 9 cycles. |
Inclusion Criteria: * Histologically proven diagnosis of Merkel cell carcinoma (MCC). * Clinical stage I-II MCC (AJCC 8th edition) either newly diagnosed or previously diagnosed with recent disease recurrence. This includes patients with a previous diagnosis of clinical Stage I-II who present with ...