Therapy Detail
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| Therapy Name | Enfortumab vedotin-ejfv + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Enfortumab vedotin-ejfv | Padcev | AGS-22ME|Enfortumab vedotin|AGS-22M6E|ASG-22CE | Padcev (enfortumab vedotin-ejfv) is an antibody-drug conjugate (ADC) that fuses together a human antibody against NECTIN4 and monomethyl auristatin E, which may result in inhibition of tumor growth and tumor regression (PMID: 27013195). Padcev (enfortumab vedotin-ejfv) is FDA approved for use in patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor, and a platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy, and in combination with Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy (FDA.gov). | |
| Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | 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 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 |
|---|---|---|---|---|---|---|
| NCT05923190 | Phase II | Enfortumab vedotin-ejfv Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma | Recruiting | USA | 0 |
| NCT05775471 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer | Not yet recruiting | USA | 0 |
| NCT06470282 | Phase Ib/II | Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer | Not yet recruiting | USA | 0 |
| NCT05239624 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer | Recruiting | USA | 0 |
| NCT05756569 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology | Recruiting | USA | 0 |
| NCT06356155 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer (NEPTUNE) | Not yet recruiting | USA | 0 |
| NCT06041503 | Phase II | Enfortumab vedotin-ejfv Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors | Not yet recruiting | USA | 0 |
| NCT04700124 | Phase III | Enfortumab vedotin-ejfv + Pembrolizumab Cisplatin + Gemcitabine | Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) (KEYNOTE-B15) | Active, not recruiting | USA | ROU | POL | ITA | ISR | HUN | HRV | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BGR | AUS | ARG | 12 |
| NCT06302569 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma (REPRINT) | Not yet recruiting | ITA | 0 |
| NCT04223856 | Phase III | Carboplatin + Enfortumab vedotin-ejfv + Pembrolizumab Cisplatin + Gemcitabine Carboplatin + Gemcitabine Enfortumab vedotin-ejfv + Pembrolizumab Cisplatin + Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin and Pembrolizumab, With or Without Chemotherapy, vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302) | Active, not recruiting | USA | TUR | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BEL | AUS | ARG | 7 |
| NCT05845814 | Phase Ib/II | Enfortumab vedotin-ejfv + MK-4280A Enfortumab vedotin-ejfv + MK-7684A Enfortumab vedotin-ejfv + Pembrolizumab | A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04) | Active, not recruiting | USA | NLD | ITA | ISR | GBR | FRA | ESP | CAN | AUS | 3 |
| NCT05656235 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Renal Retention in High Grade Upper Tract Urothelial Cancer | Not yet recruiting | USA | 0 |
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