An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
Summary
The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.
Timeline
- Start
- 2019-07-18
- Primary completion
- 2032-11-21
- Completion
- 2032-11-21
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper Recurrence-free survival was longer with combination versus monotherapy (hazard ratio [HR] for recurrence or death, 0·561 [95% CI 0·309-1·017]; two-sided p=0·053) reads as missed primary endpoint PMID 38246194 ↗
release “demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (RFS) versus KEYTRUDA alone” reads as met primary endpoint merck.com ↗
release “2026年ASCO公布的KEYNOTE-942五年随访数据显示，intismeran联合KEYTRUDA相较KEYTRUDA单药降低复发或死亡风险49%” reads as met primary endpoint gritbio.com ↗
release “continued to demonstrate sustained and clinically meaningful improvement in the study’s primary endpoint, recurrence-free survival (RFS)” reads as met primary endpoint merck.com ↗
release “KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA®, Merck's anti-PD-1 therapy, demonstrated a statistically significant and clinically meaningful improvement” reads as met primary endpoint q4web.com ↗
release “adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS)” reads as met primary endpoint q4web.com ↗
release “Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA reduced the risk of recurrence or death by 49%” reads as met primary endpoint q4web.com ↗
release “study's primary endpoint, recurrence-free survival (RFS), reducing the risk of recurrence or death by 49%” reads as met primary endpoint q4web.com ↗
Publications
- Khattak A, Carlino MS, Meniawy T, Ansstas G, Taylor MH, Kim KB, McKean M, Long GV, Sullivan RJ, Faries M, Tran TT, Cowey CL, Pecora A, Medina T, Atkinson V, Krepler C, Jemielita T, Mao H, Chow J, Ojalvo LS, Mehnert JM; KEYNOTE-942 Investigators. Intismeran Autogene Plus Pembrolizumab Versus Pembrolizumab Alone in High-Risk Resected Melanoma: 5-Year Update of the Randomized Phase IIb KEYNOTE-942 Study. J Clin Oncol. 2026 Jun 1:JCO2600835. doi: 10.1200/JCO-26-00835. Online ahead of print.
- Weber JS, Carlino MS, Khattak A, Meniawy T, Ansstas G, Taylor MH, Kim KB, McKean M, Long GV, Sullivan RJ, Faries M, Tran TT, Cowey CL, Pecora A, Shaheen M, Segar J, Medina T, Atkinson V, Gibney GT, Luke JJ, Thomas S, Buchbinder EI, Healy JA, Huang M, Morrissey M, Feldman I, Sehgal V, Robert-Tissot C, Hou P, Zhu L, Brown M, Aanur P, Meehan RS, Zaks T. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study. Lancet. 2024 Feb 17;403(10427):632-644. doi: 10.1016/S0140-6736(23)02268-7. Epub 2024 Jan 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Intismeran autogene | Messenger RNA (mRNA) | 1 mg | Intramuscular |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |