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 132 | 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, 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). |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 | 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 |
| 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 |
| 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) | Recruiting | USA | TUR | SWE | POL | NZL | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 4 |
| 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 |
| 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 | AUS | 1 |
| 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 |
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