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| Therapy Name | Enfortumab vedotin-ejfv + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Enfortumab vedotin-ejfv | Padcev | AGS-22ME|Enfortumab vedotin|AGS-22M6E|ASG-22CE | NECTIN4 Antibody 11 | 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, in combination with Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy, and in combination with Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant treatment for cisplatin-ineligible patients with muscle invasive bladder cancer (FDA.gov). |
| 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). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06356155 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer (NEPTUNE) | 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 |
| NCT06906822 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | PLUG-IN: Pembrolizumab Combined With Enfortumab Vedotin for Advanced Melanoma Patients (PlugIN) | Recruiting | ESP | 0 |
| NCT06764095 | FDA approved | Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin and Pembrolizumab Followed by Cystectomy And/or Ureterectomy for the Treatment of Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial | Recruiting | USA | 0 |
| NCT06493552 | Phase II | Pembrolizumab + sEphB4-HSA Pembrolizumab Enfortumab vedotin-ejfv + Pembrolizumab Cisplatin + Gemcitabine | Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors | Recruiting | USA | 0 |
| NCT05239624 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer | Recruiting | USA | 0 |
| NCT07087860 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers (RECIPE-B1) | 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 |
| NCT05656235 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Renal Retention in High Grade Upper Tract Urothelial Cancer | Recruiting | USA | 0 |
| 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 |
| NCT06470282 | Phase Ib/II | Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer | Recruiting | USA | 0 |
| NCT07183319 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab Pembrolizumab | Circulating Tumor DNA Response In Urothelial Cancer | 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) | Recruiting | ITA | 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 | Recruiting | USA | 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 |
| NCT06809140 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin Plus Pembrolizumab with Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer | Recruiting | USA | 0 |
| NCT05923190 | Phase II | Enfortumab vedotin-ejfv Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma | Recruiting | USA | 0 |
| NCT07221942 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma | Not yet recruiting | USA | 0 |
| NCT07218380 | Phase III | Enfortumab vedotin-ejfv + LOXO-435 + Pembrolizumab Enfortumab vedotin-ejfv + Pembrolizumab | A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract (FORAGER-2) | Not yet recruiting | USA | TUR | POL | NLD | ITA | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | AUS | 4 |