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A phase I multicenter study to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone in patients with resected solid tumors and in combination with pembrolizumab in patients with unresectable solid tumors.
Abstract
2523 Background: T-cell targeting of mutation-derived epitopes (neoantigens) has been demonstrated to drive anti-tumor responses. Immunizing patients against such neoantigens in combination with a checkpoint inhibitor (CPI) may elicit greater anti-tumor responses than CPI alone. Mutations are rarely shared between patients, thus requiring a personalized approach to vaccine design. Methods: A phase I dose escalation study of mRNA-4157 as adjuvant monotherapy in patients with resected solid tumors (melanoma, bladder carcinoma, HPV negative HNSCC, NSCLC, SCLC, MSI-High, or TMB High cancers) and in combination with pembrolizumab in patients with advanced or metastatic cancer is being conducted to evaluate safety. mRNA-4157 is a lipid encapsulated personalized vaccine encoding multiple neoantigens selected using a proprietary algorithm designed to induce neoantigen specific T cells and associated anti-tumor responses. Patients may receive up to 9 cycles (Q3W) of mRNA-4157 by intramuscular injection (0.04 – 1 mg). In the combination arm, pembrolizumab (200 mg) is administered for two cycles prior to combination with mRNA-4157; patients may continue pembrolizumab after completion of 9 cycles of combination therapy. Primary end points include safety, tolerability, and recommended phase 2 dose. Results: 33 patients received mRNA-4157; 13 as monotherapy and 20 in combination with pembrolizumab. No DLTs were reported, and treatment related AEs have generally been of low grade and reversible, and no drug related SAEs or AEs ≥ grade 3 have been observed. Of the 13 patients on adjuvant monotherapy (3 melanoma, 8 NSCLC, 2 MSI-High), 12 patients remain disease free on study, median follow-up of 8 months. 20 patients have been treated in combination (1 TMB-high, 4 bladder, 2 HNSCC, 1 melanoma, 7 NSCLC, 2 SCLC, 3 MSI-high), 12 had progressed on prior CPI, 16 have been restaged and there are 1 CR (on pembrolizumab prior to vaccination), 2 PR, 5 SD for at least 5 combination cycles, 5 PD, 2 iuPD, and 1 patient is non-evaluable for response but remains on study. Neoantigen specific T cell responses have been detected by IFN-γ ELISpot from PBMCs. Conclusions: mRNA-4157 is safe and well tolerated at all dose levels tested. Clinical responses have been observed in combination with pembrolizumab and neoantigen-specific T cells have been induced, supporting the advancement of mRNA-4157 to phase 2. Clinical trial information: NCT03313778.
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“Finally, the overall response rate (ORR) for the treatment of 10 cases of HPV-negative head and neck squamous cell carcinoma (HPV-HNSCC) with the mRNA-4157 vaccine was 50%, of which 2 cases achieved complete remission (CR).355–358”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [358]
In the citing paper
“Finally, the overall response rate (ORR) for the treatment of 10 cases of HPV-negative head and neck squamous cell carcinoma (HPV-HNSCC) with the mRNA-4157 vaccine was 50%, of which 2 cases achieved complete remission (CR).355–358”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [356]
In the citing paper
“Moderna’s mRNA personalized cancer vaccine mRNA-4157 is comprised of 34 unique neoantigen genes (encoded by tumor-specific mutated genes) combined in a single mRNA vaccine; this vaccine was proven safe and tolerable in combination with pembrolizumab in phase I clinical trials.”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [358]
In the citing paper
“Moderna’s mRNA personalized cancer vaccine mRNA-4157 is comprised of 34 unique neoantigen genes (encoded by tumor-specific mutated genes) combined in a single mRNA vaccine; this vaccine was proven safe and tolerable in combination with pembrolizumab in phase I clinical trials.”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [356]
In the citing paper
“Several personalized cancer vaccines using lipid nanoparticle–mRNA formulations have also entered clinical trials210–212.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [211]
In the citing paper
“In the monotherapy group, 14 out of 16 patients remained disease-free during the study, with a median follow-up time of 8 months210,211.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [211]
In the citing paper
“In the combination group, the overall response rate in the cohort (human papillomavirus-negative, immune checkpoint inhibitor-naive, head and neck squamous cell carcinomas) was 50% and the median progression-free survival was 9.8 months210,211.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [211]
In the citing paper
“For example, mRNA-4157 is a personalized cancer vaccine encoding up to 34 neoantigens210,211.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [211]
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“Although the number of cases is small, the positive effect of personalized vaccines on patients with HPV-negative HNSCC is anticipated [64].”
BackgroundCombating cancer immunotherapy resistance: a nano‐medicine perspective
Kong, X., Xie, X., Wu, J., Wang, X., Zhang, W., Wang, S., Abbasova, D. V., Fang, Y., Jiang, H., Gao, J., et al. (2025) · 癌症：英文版 · doi:10.1002/cac2.70025 · Cited by 18
Application of Nanotechnology in Therapeutic Cancer Vaccines
Guo, J., Tang, L., Li, K., Ma, Q., Luo, S., Cheng, R., & Liu, C. (2023) · Advanced NanoBiomed Research · doi:10.1002/anbr.202200122 · Cited by 14
Cancer vaccines: Discovery, development, and challenges for clinical translation
Zhang, Z., Yao, S., Wang, Y., Luo, K., Amiji, M. M., & Anderson, K. C. (2025) · Biomaterials · doi:10.1016/j.biomaterials.2025.123615 · Cited by 15
Kiessling, A., Ramanathan, K., Nilsson, O. B., Notari, L., Renken, S., Kiessling, R. W., Grönlund, H., & Wickström, S. L. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.866763 · Cited by 14
Advances in Vaccines for Melanoma
Cui, C., Ott, P. A., & Wu, C. J. (2024) · Hematology/Oncology Clinics of North America · doi:10.1016/j.hoc.2024.05.009 · Cited by 16
mRNA-based personalized cancer vaccines: opportunities, challenges and outcomes
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Neoantigens: The Novel Precision Cancer Immunotherapy
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“Of particular signi fi cance, two of the 12 patients particular significance, two of the 12 patients who had previously undergone ICIs showcased clinical responses, illustrating the potential of this approach to benefit patients who had previously exhibited disease progression on ICI therapies [51].”
BackgroundIndividualized Neoantigen-Directed Melanoma Therapy
Khaddour, K., & Buchbinder, E. I. (2025) · American Journal of Clinical Dermatology · doi:10.1007/s40257-025-00920-4 · Cited by 13
Breaking barriers: Smart vaccine platforms for cancer immunomodulation
Gomari, M. M., Ghantabpour, T., Pourgholam, N., Rostami, N., Hatfield, S. M., Namazifar, F., Abkhiz, S., Eslami, S. S., Ramezanpour, M., Darestanifarahani, M., et al. (2025) · 癌症：英文版 · doi:10.1002/cac2.70002 · Cited by 17
Therapeutic mRNA vaccine applications in oncology
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“Furthermore, in patients receiving combination therapy, 5% experienced a complete response prior to vaccination, 11% experienced a partial response, 36% had stable disease, 36% experienced confirmed disease progression, and 11% had uncon-firmed disease progression [52].”
Delivery of Immunostimulatory Cargos in Nanocarriers Enhances Anti-Tumoral Nanovaccine Efficacy
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“Using nanoparticles (NPs) as delivery vehicles for antigens, adjuvants or drugs ensures their protected transport, prolonged bioavailability and controlled release [99].”
BackgroundVaccines for Non-Viral Cancer Prevention
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“Although several clinical trials have shown that combinatorial therapies [71,72] could partially overcome these challenges, the full potential of neoantigen-based vaccines would be in a preventive approach.”
BackgroundIndividualized mRNA Vaccines in Melanoma—Where Do We Stand?
Gazouli, I., Bafaloukos, D. I., Koutserimpas, C., & Samonis, G. (2025) · Vaccines · doi:10.3390/vaccines13090986 · Cited by 11
“In this form, it may be refrigerated, stocked, and transferred, let alone easily administered to the patient by a simple intramuscular injection [39–44] (see Figure 1).”
InfluentialCarlino, M. S., Khattak, M. A., Meniawy, T. M., Ansstas, G., Taylor, M. H., Kim, K. B., McKean, M. A., Long, G. V., Sullivan, R. J., Faries, M. B., et al. (2026) · JCO oncology advances. · doi:10.1200/oa-25-00008 · Cited by 11
Self-citationThe dawn of a new Era: mRNA vaccines in colorectal cancer immunotherapy
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“Based on these encouraging findings, mRNA-4157 is now advancing to Phase II clinical trials [125].”
Formulation and delivery solutions for the next generation biotherapeutics
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“…on cancer mRNA vaccines have focused on shared tumor antigens but mRNA vaccination is also very suitable for personalized cancer vaccines in which a set of unique neoantigens, identified by next generation sequencing on tumor biopsies, can be readily expressed in a short timeframe [67 – 69].”
BackgroundSurfaceome: a new era in the discovery of immune evasion mechanisms of circulating tumor cells
Masmoudi, D., Vialaret, J., Hirtz, C., & Alix‐Panabières, C. (2024) · Molecular Oncology · doi:10.1002/1878-0261.13665 · Cited by 8
“Similarly, the combination of the mRNA-based vaccine 4157 and pem-brolizumab showed a 30% response rate in patients with advanced or metastatic cancer [119].”
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Chondroitin sulfate proteoglycan 4: An attractive target for antibody-based immunotherapy
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mRNA—From COVID-19 Treatment to Cancer Immunotherapy
Kŕause, W. (2023) · Biomedicines · doi:10.3390/biomedicines11020308 · Cited by 8
Advancement insights in cancer vaccines: mechanisms, types, and clinical applications
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“In addition, personalized neoantigen vaccines have been combined with inhibitors of programmed cell death 1 or programmed cell death ligand 1 (PD-1 or PD-L1) in early clinical trials to improve anti-tumor activity [22].”
Metadata
- Authors
- Burris, H. A., Patel, M. R., Cho, D. C., Clarke, J. M., Gutierrez, M., Zaks, T. Z., Frederick, J., Hopson, K., Mody, K., Binanti-Berube, A., Robert-Tissot, C., Goldstein, B., Breton, B., Sun, J., Zhong, S., Pruitt, S. K., Keating, K., Meehan, R. S., & Gainor, J. F.
- Affiliations
- Sarah Cannon (US)
- Florida Cancer Specialists, Sarasota, FL;
- New York University (US)
- Duke Medical Center (US)
- Hackensack University Medical Center (US)
- Moderna Therapeutics (United States) (US)
- Moderna Tx, Cambridge, MA;
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Massachusetts General Hospital (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2019-05-20
- Volume
- 37
- Issue
- 15_suppl
- Pages
- 2523-2523
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2947382141
- Cited by
- 144
- References
- 0
- Citations by year
- 2026: 13 · 2025: 31 · 2024: 18 · 2023: 31 · 2022: 22 · 2021: 18 · 2020: 11
- Type
- conference abstract
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Keywords
- personalized cancer vaccines, neoantigens, pembrolizumab, immune checkpoint inhibitors, solid tumors, adjuvant therapy, safety and tolerability, immunogenicity, tumor mutational burden, microsatellite instability, non-small cell lung cancer, melanoma, bladder cancer, head and neck squamous cell carcinoma, small cell lung cancer, dose escalation
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