Table 4.
Ongoing trials in MCC.
| Trial | Design | N' of patients | Indication | Intervention |
|---|---|---|---|---|
|
NCT02488759 (CheckMate358) |
Phase I/II | 578 | Virus-associated diseases (MCC) | Nivolumab intravenous infusion as specified - Nivolumab intravenous infusion as specified - Nivolumab intravenous infusion as specified with Ipilimumab intravenous infusion as specified - Nivolumab intravenous infusion as specified with Relatlimab intravenous infusion as specified - Nivolumab intravenous infusion as specified with Daratumumab intravenous infusion as specified |
|
NCT03712605 (STAMP) |
Phase III | 280 | Resected MCC | Arm A: Pembrolizumab IV over 30 min on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. |
| Arm B: standard of care observation every 3 months for 1 year, and then every 6 months for 5 years. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. | ||||
|
NCT03271372 (ADAMI) |
Phase III | 100 | Resected MCC with nodal metastasis | Arm A: Avelumab IV over 1 h once every 15 days for the first 120 days (Induction Phase 1), once every 30 days for the next 120 days (Induction Phase 2), and then once every 120 days (Maintenance Phase) for a maximum of 720 days (~24 months or 2 years total) in the absence of disease progression or unacceptable toxicity. |
| Arm B: placebo IV over 1 h once every 15 days for the first 120 days (Induction Phase 1), once every 30 days for the next 120 days (Induction Phase 2), and then once every 120 days (Maintenance Phase) for a maximum of 720 days (~24 months or 2 years total) in the absence of disease progression or unacceptable toxicity. | ||||
|
NCT04291885 (I-MAT) |
Phase II | 132 | Resected MCC | Arm A: 6 months of Avelumab at a dose of 800 mg as a 60-min intravenous (IV) infusion once every 2 weeks (13 doses) |
| Arm B: 6 months of Placebo as a 60-min intravenous (IV) infusion once every 2 weeks (13 doses) | ||||
|
NCT02196961 (ADMEC-O) |
Phase II | 180 | Resected MCC | After complete resection of Merkel cell carcinoma, patients randomized to the treatment arm will receive nivolumab at a fixed dose of 480 mg by IV infusion every 4 weeks for up to 1 year (i.e., 13 doses). |
| NCT03798639 | Phase I | 7 | Resected MCC | Arm A: Nivolumab IV over 30 min at week 0. Treatments repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. |
| 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. | ||||
| NCT03684785 | Advanced MCC/advanced CSCC | |||
| NCT04799054 | Locally advanced/metastatic solid tumors | |||
| NCT02465957 (QUILT-3.009) | Advanced MCC | |||
| NCT03747484 | Unresectable/metastatic MCC | |||
| NCT03458117 | Locally advanced NMSC | |||
| NCT02819843 | Solid tumors with skin metastasis, including MCC | |||
| NCT02978625 | Advanced/refractory NMSC | |||
| NCT04160065 | Advanced CSCC/MCC |