Therapy Detail
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| Therapy Name | Intismeran autogene + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Intismeran autogene | mRNA4157|mRNA 4157|V940|V-940|V 940|mRNA-4157 | Intismeran autogene (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). | ||
| Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 136 | 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, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and 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, with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive cervical cancer, with gemcitabine and cisplatin for biliary tract cancer, with chemoradiation for cervical cancer, with carboplatin and paclitaxel for endometrial carcinoma, with paclitaxel with or without bevacizumab for epithelial ovarian, Fallopian tube, and peritonium cancer (FDA.gov). |
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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 |
|---|---|---|---|---|---|---|
| NCT06961006 | Phase II | Intismeran autogene + Pembrolizumab Pembrolizumab | A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012) | Recruiting | USA | POL | NZL | ITA | ISR | GRC | FRA | ESP | DEU | CAN | AUS | 1 |
| NCT06305767 | Phase Ib/II | Pembrolizumab Intismeran autogene + Pembrolizumab | A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005) | Active, not recruiting | USA | TUR | SWE | POL | NZL | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 4 |
| NCT03897881 | Phase II | Intismeran autogene + 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) | Active, not recruiting | USA | AUS | 0 |
| NCT06295809 | Phase II | Pembrolizumab Intismeran autogene + Pembrolizumab | A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) (INTerpath-007) | Active, not recruiting | USA | ROU | POL | NZL | NOR | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG | 2 |
| NCT03313778 | Phase I | Intismeran autogene + Pembrolizumab Intismeran autogene | Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (KEYNOTE-603) | Active, not recruiting | USA | GBR | AUS | 1 |
| NCT06623422 | Phase III | Paclitaxel Intismeran autogene + Pembrolizumab Gemcitabine Carboplatin Pembrolizumab Pemetrexed Disodium Cisplatin | A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) | Recruiting | USA | TUR | SWE | ROU | POL | NZL | NLD | ITA | ISR | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DEU | CAN | BRA | BGR | BEL | AUS | ARG | 8 |
| NCT06307431 | Phase II | Pembrolizumab Intismeran autogene + Pembrolizumab | A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004). (INTerpath-004) | Active, not recruiting | USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CAN | AUS | ARG | 3 |
| NCT05933577 | Phase III | Pembrolizumab Intismeran autogene + Pembrolizumab | A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) | Active, not recruiting | USA | TUR | SWE | POL | NZL | ITA | ISR | GRC | GBR | FRA | ESP | DNK | DEU | CHE | CAN | BRA | BEL | AUS | ARG | 7 |
| NCT06077760 | Phase III | Intismeran autogene + Pembrolizumab Pembrolizumab | A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002) (INTerpath-002) | Recruiting | USA | TUR | SVK | POL | NZL | NOR | LVA | LTU | ITA | IRL | HUN | GRC | FRA | FIN | EST | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUS | ARG | 9 |
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