Table 2.
Published and ongoing RCT for ICIs in MCC
| First name(s) | Molecule(s) | Full Title | Year | Journal | Patients, n | Type of study | Primary outcome(s) |
|---|---|---|---|---|---|---|---|
| Kaufman HL* | Avelumab | Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial | 2016 | Lancet Oncol | 88 | multicentre, prospective, open-label clinical trial |
Best Overall Response Durable Response Rate |
| Topalian SL | Nivolumab | [ABSTRACT] Non-comparative, open-label, multiple cohort, phase 1/2 study to evaluate nivolumab (NIVO) in patients with virus associated tumors (CheckMate 358): Efficacy and safety in Merkel cell carcinoma (MCC) | 2017 | Cancer Res | 25 | multicentre, prospective, open-label clinical trial |
Objective Response Rate Safety |
| Kaufman HL* | Avelumab | Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after 1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial | 2018 | J Immunother Cancer | 88 | * | * |
| D’Angelo SP** | Avelumab | Efficacy and safety of first-line avelumab treatment in patients with stage IV metastatic merkel cell carcinoma | 2018 | JAMA Oncol | 39 | multicenter, single-arm, open-label clinical trial |
Objective Response Rate Duration of Response Safety |
| Nghiem P | Pembrolizumab | Durable tumor regression and overall survival in patients with advanced Merkel cell carcinoma receiving pembrolizumab as first-line therapy | 2019 | J Clin Oncol | 50 | multicenter, non-randomized, open-label clinical trial |
Objective Response Rate Progression-free Survival Overall Survival Adverse Events |
| Knepper TC |
Avelumab or Pembrolizumab or Nivolumab or Ipilimumab + Nivolumab |
The Genomic Landscape of Merkel Cell Carcinoma and Clinicogenomic Biomarkers of Response to Immune Checkpoint Inhibitor Therapy | 2019 | Clin Cancer Res | 36 | retrospective | Response Rate |
| LoPiccolo J | various | Rescue therapy for patients with anti-PD-1-refractory Merkel cell carcinoma: a multicenter, retrospective case series | 2019 | J Immunother Cancer | 13 | retrospective case series | Objective Response |
| Topalian SL | Nivolumab | Neoadjuvant Nivolumab for Patients With Resectable Merkel Cell Carcinoma in the CheckMate 358 Trial | 2020 | J Clin Oncol | 39 | non-comparative, open-label clinical trial |
Objective Response Rate Incidence of Adverse Events Rate of surgery delay |
| Spassova I |
Avelumab or Pembrolizumab or Nivolumab |
Predominance of central memory T cells with high Tcell receptor repertoire diversity is associated with response to PD-1/PD-L1 inhibition in Merkel cell carcinoma | 2020 | Clin Cancer Res | 41 | retrospective | Overall Response |
| Bystrup Boyles T | Pembrolizumab | Pembrolizumab as first line treatment of Merkel cell carcinoma patients—a case series of patients with various co-morbidities | 2020 | Acta Oncol | 7 | prospective |
Objective Response Rate Incidence of Adverse Events Overall Survival Progression-free Survival |
| Levy S | Avelumab | Avelumab for advanced Merkel cell carcinoma in the Netherlands: a real-world cohort | 2020 | J Immunother Cancer | 54 | multicenter, retrospective |
Response Rate Duration of Response |
| Walker JW | Avelumab | Efficacy and safety of avelumab treatment in patients with metastatic Merkel cell carcinoma: experience from a global expanded access program | 2020 | J Immunother Cancer | 240 | retospective | Response Rate |
| Glutsch V | Ipilimumab + Nivolumab | Activity of ipilimumab plus nivolumab in avelumab-refractory Merkel cell carcinoma | 2021 | Cancer Immunol Immunother | 5 | retospective |
Response Rate Incidence of Adverse Events |
*Studies comprising the same patients, part of Javeli trial part a
**Javelin part b