Table 3.
Ongoing trials in CSSC.
| Trial | Design | N' of patients | Indication | Intervention | ORR |
|---|---|---|---|---|---|
| NCT02883556 (CARSKIN) | Phase II | 57 | Unresectable CSCC | Pembrolizumab 200 mg, administered as intravenous (IV) infusion every 3 weeks up to 24 months or until progression or unacceptable toxicity develops. | ORRW15 41% |
| NCT02721732 | Phase II | 202 | Unresectable/mCSCC | Pembrolizumab IV over 30 min on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or toxicity. Patients with clinical response or disease stabilization may continue treatment for up to an additional 12 months. | 32% |
| NCT02964559 | Phase II | 11 | laCSCC/mCSCC | Pembrolizumab IV over 30 min on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. | |
|
NCT03284424 (MK-3475-629/KEYNOTE-629) |
Phase II | 159 | laCSCC/mCSCC/recurrent CSCC | Pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to ~2 years. | |
| NCT03057613 | Phase II | 18 | Resected H&N CSCC | IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks | |
|
NCT03833167 (MK-3475) |
Phase III | 570 | Resected high-risk CSCC | Arm A: 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design. | |
| Arm B: placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design. | |||||
| NCT03969004 | Phase III | 412 | Resected high-risk CSCC | Arm A: Cemiplimab Intravenous (IV) infusion over 30 minutes | |
| Arm B: Placebo Intravenous (IV) infusion over 30 min | |||||
|
NCT03834233 (CA209-9JC) |
Phase II | 24 | laCSCC/mCSCC | Nivolumab 3 mg/kg IV every 14 days until disease progression, unacceptable toxicity or up to 12 months. | |
| NCT04204837 | Phase II | 31 | laCSCC/mCSCC | Nivolumab will be given on Day 1 of every 14-day cycle (Q2W) at a dose of 240 mg as an IV infusion until progression, unacceptable toxicity or discontinuation for other reasons for up to 2 years. | |
| Arm B: Nivolumab IV over 30 min and ipilimumab IV over 30 min at week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1 year in the absence of disease progression or unacceptable toxicity. | |||||
| NCT03565783 | Phase I | 40 | H&N CSCC | Cemiplimab IV over 30 min every 3 weeks. Cycles repeat every 3 weeks for up to 6 weeks with or without radiation therapy at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity. | |
| NCT04807777 | Solid organ transplant recipients with advanced CSCC | ||||
| NCT04349436 (ARTACUS) | Liver/Kidney transplant recipient with advanced CSCC | ||||
| NCT03684785 | Advanced MCC/advanced CSCC | ||||
| NCT04799054 | Locally advanced/metastatic solid tumors | ||||
| NCT04596033 (TiTAN-1) | Advanced solid tumors including CSCC | ||||
| NCT03458117 (20139157 T-VEC) | Locally advanced NMSC | ||||
| NCT02978625 | Advanced/refractory NMSC | ||||
| NCT04160065 | Advanced CSCC/MCC | ||||
| NCT04502888 | Advanced CSCC | ||||