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intismeran autogene (mRNA-4157)
i
Other names: mRNA-4157, mRNA 4157, V940, mRNA4157, V 940, V-940
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News alerts, weekly reports and conference planners
Company:
Merck (MSD), Moderna
Drug class:
Immunostimulant
Related drugs:
1d
An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942) (clinicaltrials.gov)
P2, N=267, Active, not recruiting, ModernaTX, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Sep 2029 --> Nov 2032 | Trial primary completion date: Sep 2029 --> Nov 2032
Enrollment closed • Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab) • intismeran autogene (mRNA-4157)
7d
KEYNOTE-603: Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (clinicaltrials.gov)
P1, N=242, Active, not recruiting, ModernaTX, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden)
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EGFR mutation • ALK positive • ALK translocation • EGFR positive
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Keytruda (pembrolizumab) • MK-3475 SC • intismeran autogene (mRNA-4157)
1m
INTerpath-13: A Study of V940/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013) (clinicaltrials.gov)
P2, N=180, Not yet recruiting, Merck Sharp & Dohme LLC
New P2 trial
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Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • intismeran autogene (mRNA-4157)
2ms
Next-Generation mRNA Vaccines in Melanoma: Advances in Delivery and Combination Strategies. (PubMed, Cells)
Clinical milestones, including the randomized phase IIb KEYNOTE-942, show that adding the personalized neoantigen vaccine mRNA-4157 (V940) to pembrolizumab prolonged recurrence-free survival versus pembrolizumab alone (HR 0.561, 95% CI 0.309-1.017; 18-month RFS 79% vs. 62%), with the ASCO 3-year update reporting 2.5-year RFS 74.8% vs. 55.6% and sustained distant metastasis-free survival benefit in resected high-risk melanoma. Parallel preclinical studies highlight the potential of multifunctional platforms co-delivering cytokines or innate agonists to reshape the tumor microenvironment and achieve durable systemic immunity. As artificial intelligence drives epitope selection and modular manufacturing accelerates personalization, mRNA vaccines may have the potential to transition from adjuncts to main therapies in melanoma and beyond.
Review • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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TMB (Tumor Mutational Burden)
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TMB-H
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Keytruda (pembrolizumab) • intismeran autogene (mRNA-4157)
3ms
INTerpath-007: A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) (clinicaltrials.gov)
P2/3, N=46, Active, not recruiting, Merck Sharp & Dohme LLC | N=1012 --> 46
Enrollment change
|
Keytruda (pembrolizumab) • intismeran autogene (mRNA-4157)
4ms
Personalized precision: Revolutionizing cancer treatment with mRNA-based vaccines in melanoma therapy. (PubMed, Adv Immunol)
Early clinical trials suggest pembrolizumab and mRNA-4157/V940 may boost T cell-mediated cancer killing. Knowing the status and problems of melanoma therapeutic mRNA cancer vaccines in clinical trials is critical. In this chapter, we have focused on preclinical and clinical advances that have revealed mRNA melanoma vaccine manufacturing issues and solutions.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • PD-L2 (Programmed Cell Death 1 Ligand 2)
|
Keytruda (pembrolizumab) • intismeran autogene (mRNA-4157)
4ms
KEYNOTE-603: Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (clinicaltrials.gov)
P1, N=242, Recruiting, ModernaTX, Inc. | Trial completion date: Jun 2025 --> Aug 2027 | Trial primary completion date: Jun 2025 --> Aug 2027
Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden)
|
EGFR mutation • ALK positive • ALK translocation • EGFR positive
|
Keytruda (pembrolizumab) • MK-3475 SC • intismeran autogene (mRNA-4157)
6ms
A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012) (clinicaltrials.gov)
P2, N=160, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
Enrollment open
|
Keytruda (pembrolizumab) • intismeran autogene (mRNA-4157)
7ms
A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012) (clinicaltrials.gov)
P2, N=160, Not yet recruiting, Merck Sharp & Dohme LLC
New P2 trial
|
Keytruda (pembrolizumab) • intismeran autogene (mRNA-4157)
8ms
A Clinical Study of V940 and BCG in People With Bladder Cancer (V940-011/INTerpath-011) (clinicaltrials.gov)
P2, N=308, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
Enrollment open
|
TheraCys (PMCJ-9) • intismeran autogene (mRNA-4157)
9ms
INTerpath-004: A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004). (clinicaltrials.gov)
P2, N=272, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
Enrollment closed
|
Keytruda (pembrolizumab) • intismeran autogene (mRNA-4157)
10ms
A Clinical Study of V940 and BCG in People With Bladder Cancer (V940-011/INTerpath-011) (clinicaltrials.gov)
P2, N=308, Not yet recruiting, Merck Sharp & Dohme LLC
New P2 trial
|
TheraCys (PMCJ-9) • intismeran autogene (mRNA-4157)
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