Table 1.
Immune checkpoint blockade in cutaneous squamous cell carcinoma (cSCC) patients.
| Author, Year [Reference] | Design | n | Intervention | ORR | PR | CR | PFS (Months) | OS (Months) | 1-Year OS | AEs ≥Grade 3 |
|---|---|---|---|---|---|---|---|---|---|---|
| Day 2017 [56] | Case report | 1 | Ipi * | 1/1 | 1/1 | 0/1 | ≥8 | - | - | 0 |
| Borradori 2016 [57] | Case series | 2 | Pem 2 mg/kg | 1/2 | 1/2 | 0/2 | ≥4, ≥7 | - | - | 0 |
| 3 | Nivo 3 mg/kg | 1/2 | 1/2 | 0/2 | 6 to ≥7 | - | - | 0 | ||
| Beasley 2017 [62] | Case series | 17 | Nivo 3 mg/kg | 14/18 | 10/18 | 4/18 | - | - | - | 3/18 (fatigue, haemolytic anemia, colitis) |
| 1 | Pem 2 mg/kg | |||||||||
| Blum 2018 [63] | Case series | 2 | Nivo 3 mg/kg | 3/3 | 3/3 | 0/3 | - | - | - | 0 |
| 1 | Nivo 200 mg fix | |||||||||
| Goldman 2018 [58] | Case report | 1 (OTR) | Nivo 3 mg/kg | 1/1 | 1/1 | 0/1 | ≥18 | - | - | allograft rejection |
| Fujimura 2020 [60] | Case report | 1 | Nivo 240 mg fix | 1/1 | 0/1 | 1/1 | - | - | - | - |
| Oliveira 2018 [59] | Case report | 1 | Nivo 3 mg/kg | 1/1 | 1/1 | 0/1 | ≥12 | - | - | 0 |
| Oro-Ayude 2020 [61] | Case report | 1 | Nivo 3 mg/kg | 1/1 | 0/1 | 1/1 | - | - | - | 0 |
| Assam 2016 [72] | Case report | 1 | Pem 2 mg/kg | 1/1 | 0/1 | 1/1 | - | - | - | 0 |
| Chang 2016 [73] | Case report | 1 | Pem 2 mg/kg | 1/1 | 0/1 | 1/1 | - | - | - | unclear |
| Cristancho 2020 [80] | Case report | 1 | Pem 200 mg fix | 1/1 | 0/1 | 1/1 | - | - | - | 0 |
| Degache 2018 [77] | Case series | 2 | Pem 2 mg/kg | 2/2 | 2/2 | 0/2 | - | - | - | 0 |
| Deinlein 2017 [75] | Case report | 1 (XP patient) | Pem 2 mg/kg | 1/1 | 1/1 | 0/1 | - | - | - | 0 |
| Delaitre 2020 [81] | Case report | 1 | Pem 2 mg/kg | 1/1 | 0/1 | 1/1 | - | - | - | 0 |
| Ferrarotto 2017 [64] NCT02721732 |
Phase II | 11 | Pem 200 mg fix | 4/11 | 4/11 | 0/11 | - | - | - | 0 |
| Grob 2020 [65] KEYNOTE-629 NCT03284424 |
Phase II | 105 | Pem 200 mg fix | 36/105 | 32/105 | 4/105 | 6.9 | n.r. | 60.3% | 6 (5.7%, grade 3–5) |
| Hermel 2018 [68] | EAP | 8 | Pem 2 mg/kg | 4/8 | 4/8 | 0/8 | - | - | - | 0 |
| Khaddour 2019 [82] | Case report | 1 (allo-HCT) | Pem 200 mg fix | 1/1 | 0/1 | 1/1 | ≥ 24 | - | - | 0 |
| Lavaud 2019 [69] | Retrospective analysis/case series | 4 | Pem 2 mg/kg | 2/4 | 0/4 | 2/4 | 14.4 | 15.6 | - | 0 |
| Lipson 2016/2020 [70,71] | Case report | 1 (OTR) | Pem 2 mg/kg | 1/1 | 0/1 | 1/1 | - | - | - | allograft rejection |
| Maubec 2020 [67] CARSKIN trial NCT02883556 |
Phase II | 39 (primary cohort) | Pem 200 mg fix | 16/39 | 13/39 | 3/39 | 6.7 | 25.3 | 75.5% | 4 (7%) |
| 18 (expansion cohort) | Pem 200 mg fix | 8/18 | 7/18 | 1/18 | - | - | - | - | ||
| Ma 2020 [79] | Case report | 1 | Pem 2 mg/kg | 1/1 | 0/1 | 1/1 | ≥17 | - | - | 0 |
| Steineck 2019 [78] | Case report | 1 (XP patient) | Pem | 1/1 | 1/1 | 0/1 | ≥18 | - | - | - |
| Stevenson 2017 [76] | Case report | 1 | Pem 2 mg/kg | 1/1 | 0/1 | 1/1 | - | - | - | 0 |
| Tran 2017 [74] | Case series | 4 | Pem 2 mg/kg | 3/4 | 2/4 | 1/4 | 3 to 10.5 | - | - | 0 |
| 1 | Nivo 3 mg/m2 | 1/1 | 1/1 | 0/1 | 12 | - | - | 0 | ||
| Yushak 2019 [66] NCT02964559 |
Phase II | 11 | Pem 200 mg fix | 6/11 | 4/11 | 2/11 | ≥6 | - | - | 3 AEs reported |
| Escobar 2020 [86] | Case report | 1 | Cem 3 mg/kg Q2W | 1/1 | 1/1 | 0/1 | ≥8 | - | - | unclear |
| Migden 2018/2020, Rischin 2020 [83,84,85] NCT02383212 (phase I) NCT02760498 (phase II) |
Phase I (la) | 26 | Cem 3 mg/kg | 13/26 | 13/26 | 0/26 | - | - | - | 6/26 |
| Phase II (m) | 59 | 28/59 | 24/59 | 4/59 | n.r. | n.r. | 81% | 17/59 | ||
| Phase II (la) | 78 | 34/78 | 24/78 | 10/78 | n.r. | n.r. | 93% | 8/78 | ||
| Phase II (m) | 56 | Cem 350 mg fix | 23/56 | 20/56 | 3/56 | n.r. | n.r. | 76.1% | 7/56 | |
| Miller 2017 [91] | Case report | 1 (OTR) | Ipi and nivo * | 1/1 | 1/1 | 0/1 | - | - | - | allograft rejection |
| Trager 2020 [92] | Case report | 1 (OTR) | Ipi 3 mg/kg and nivo 1 mg/kg | 1/1 | 1/1 | 0/1 | ≥9 | - | - | unclear |
Note: - = not reported; EAP = expanded access program; ORR = overall response rate; PR = partial response; CR = complete response; PFS = progression-free survival; OS = overall survival; n.r. = not reached; AEs = adverse events; OTR = organ transplant recipient; XP = xeroderma pigmentosum patient; allo-HCT = allogeneic hematopoietic cell transplantation; la = locally advanced; m = metastatic; ipi = ipilimumab; pem = pembrolizumab; nivo = nivolumab; cem = cemiplimab; AE = adverse events; * no dosage reported in the studies.