Trial reportAmerican journal of clinical dermatology2024
Pembrolizumab for the First-Line Treatment of Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma: Results from the Single-Arm, Open-Label, Phase III KEYNOTE-913 Study.
Trial report in American journal of clinical dermatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03783078 (A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab), which is not on this map. Cited by 6 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) as First Line Therapy in Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-913)
Who cites it
6 citing papers in PubMed.
- Phase II study of retifanlimab in patients with recurrent locally advanced or metastatic Merkel cell carcinoma (POD1UM-201).Journal for immunotherapy of cancer · 2025Trial
- [Merkel cell carcinoma: current surgical approaches and multidisciplinary treatment].Revista medica del Instituto Mexicano del Seguro Social · 2026Review
- Merkel Cell Carcinoma of the Thigh Presenting as a Hemorrhagic Mass: A Rare Case Report and Literature Review.Current oncology (Toronto, Ont.) · 2026Review
- Merkel Cell Carcinoma: Evolving Therapeutics, Continued Challenges.Head & neck · 2025Review
- Immune checkpoint inhibitors for the treatment of solid tumors and lymphoma in the past 26 years (2000-2025).Journal of hematology & oncology · 2025Review
- The Epidemiology of Neuroendocrine Carcinomas in Taiwan: A Population-Based Cancer Registry Study.Cancer medicine · 2025Article
Corrections and comments
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Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe phase III KEYNOTE-913 study was conducted to evaluate the efficacy and safety of pembrolizumab as first-line therapy in patients with advanced Merkel cell carcinoma (MCC).
objectiveThe aim was to report results from the primary analysis of KEYNOTE-913. PATIENTS AND
methodsPatients with recurrent locally advanced or metastatic MCC received pembrolizumab 200 mg intravenously every 3 weeks for up to 35 treatments (~ 2 years). The primary end point was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central review (BICR). Secondary end points were duration of response (DOR) and progression-free survival (PFS) per RECIST v1.1 by BICR, overall survival (OS), and safety and tolerability.
resultsFifty-five patients were treated with pembrolizumab. The median time from first dose to data cutoff (February 15, 2024) was 50.3 months (range 38.7-59.4). The ORR was 49% (95% confidence interval [CI] 35-63), with 12 complete responses and 15 partial responses. The median DOR was 39.8 months (range 4.8-52.5+), and the 24-month DOR rate was 69%. The median PFS was 9.3 months (95% CI 3-26), and the 24-month PFS rate was 39%. The median OS was 24.3 months (95% CI 12.4 to not reached), and the 24-month OS rate was 51%. Any-grade treatment-related adverse events (AEs) occurred in 38 patients (69%); 13 patients (24%) experienced grade 3-5 AEs. The most common treatment-related AEs were fatigue (n = 12 [22%]), pruritus (n = 12 [22%]), and lipase increase (n = 10 [18%]). One patient died of treatment-related Guillain-Barré syndrome.
conclusionsPembrolizumab provided durable antitumor activity and promising survival and had a manageable safety profile in patients with recurrent locally advanced or metastatic MCC, supporting its use in this population.
trial registrationClinicaltrials.gov, NCT03783078.
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