Table V.
Major studies investigating immune-checkpoint inhibitors to treat cutaneous malignancy
| Type of cutaneous malignancy | Investigating agents/Regimen | Trial identifier/Current phase | Patient population | Median follow-up | Efficacy | Adverse event | |
|---|---|---|---|---|---|---|---|
| Common | Rare/Serious | ||||||
| Cutaneous squamous cell carcinoma | Cemiplimab [Libtayo®] 3mg/kg q2w |
EMPOWER-CSCC-1 NCT02760498 Phase 2 trial | 59 patients with metastatic cSCC | 16.5 months | ORR, 49.2% CR, 6.8% PR, 42.4% SD, 13.5% PD, 37.3% PFS, 18.4 months | Diarrhea (28.8%), fatigue (25.4%), nausea (23.7%). | Cellulitis, pneumonitis, hypercalcemia, pleural effusion and death |
| Cemiplimab [Libtayo®] 3mg/kg q2w |
NCT02383212 Phase 1 trial with expansion cohort | 26 patients with locally advanced or metastatic cSCC | 11.0 months | ORR, 50.0% CR, 0.0% PR, 50.0% SD, 23.0% PD, 27.0% PFS, not reported | Fatigue (26.9%), constipation (15%), decreased appetite (15%), diarrhea (15%), nausea (15%), constipation (15%), hypercalcemia (15%), hypophosphatemia (15%), urinary tract infection (15%) | Asthenia, maculopapular rash, increased alanine aminotransferase, increased aspartate aminotransferase, adrenal insufficiency, and myalgia | |
| Merkel cell carcinoma | Avelumab [Bavencio®] 10mg/kg q2w | JAVELIN Merkel 200 NCT02155647 Phase 2 (Part A) trial | 88 patients with stage IV MCC that is refractory to chemotherapy | 16.4 months | ORR, 33.0% CR, 11.4% PR, 21.6% SD, 10.2% PD, 36.4% PFS, 2.7 months | Fatigue (24%), infusion-related reactions (17%), diarrhea (9%), nausea (9%), asthenia, (9%), rash (7%), decreased appetite (6%) | Lymphopenia (2%), increased serum creatine phosphokinase (1%), aminotransferase (1%), and cholesterol (1%) levels, enterocolitis (1%), chondrocalcinosis (1%), synovitis (1%), and interstitial nephritis (1%) |
| JAVELIN Merkel 200 NCT02155647 Phase 2 (Part B) trial | 39 patients with metastatic MCC who had not received prior systemic treatment | 5.1 months | ORR, 62.1% CR, 13.8% PR, 48.3% SD, 10.3% PD, 27.6% PFS, 9.1months | Infusion-related reactions (23.1%) | Cholangitis, elevated aspartate and alanine aminotransferase levels, paraneoplastic syndrome, gait disturbance, paraneoplastic encephalomyelitis, and polyneuropathy | ||
| Pembrolizumab [Keytruda®] 2mg/kg q3w |
KEYNOTE-017 NCT02267603 Phase 2 trial | 50 patients (26 from original cohort and 24 from expansion cohort) with advanced MCC who had not received systemic treatment | 14.9 months | ORR, 56.0% CR, 24.0% PR, 32.0% SD, 10.0% PD, 32% PFS, 16.8 months | Fatigue and laboratory abnormalities | Myocarditis, elevated liver enzyme, death | |
Abbreviations: ORR: Objective response rate; CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; PFS: Progression-free survival