Therapy Detail

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Therapy Name mRNA-4157 + Pembrolizumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 148 PD-L1/PD-1 antibody 117 Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, in combination with chemoradiation for cervical cancer, and in combination with carboplatin and paclitaxel for endometrial carcinoma (FDA.gov).
mRNA-4157 mRNA4157|mRNA 4157|V940|V-940|V 940 mRNA-4157 is an mRNA-based lipid encapsulated personalized cancer vaccine encoding specific neoantigens, which potentially leads to enhanced anti-tumor immune response (Journal for ImmunoTherapy of Cancer 2020;8).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06077760 Phase III mRNA-4157 + Pembrolizumab Pembrolizumab A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002) Recruiting USA | NZL | ITA | FRA | ESP | CAN | AUS 16
NCT06305767 Phase II Pembrolizumab mRNA-4157 + Pembrolizumab A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005) Recruiting USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | AUS 3
NCT03897881 Phase II mRNA-4157 + Pembrolizumab Pembrolizumab An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Patients With High-Risk Melanoma (KEYNOTE-942) Recruiting USA | AUS 0
NCT05933577 Phase III Pembrolizumab mRNA-4157 + Pembrolizumab A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) Recruiting USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 16
NCT03313778 Phase I mRNA-4157 + Pembrolizumab mRNA-4157 Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (KEYNOTE-603) Recruiting USA | AUS 0
NCT06295809 Phase II Pembrolizumab mRNA-4157 + Pembrolizumab A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) Recruiting USA | NZL | FRA | ESP | AUS 3
NCT06307431 Phase II Pembrolizumab mRNA-4157 + Pembrolizumab A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004) Recruiting USA | GBR | CAN | AUS 3


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