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 | 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 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| NCT06041503 | Phase II | Enfortumab vedotin-ejfv Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE) | Recruiting | USA | 0 |
| NCT07183319 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab Pembrolizumab | Circulating Tumor DNA Response In Urothelial Cancer | Recruiting | USA | 0 |
| NCT05656235 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Renal Retention in High Grade Upper Tract Urothelial Cancer | Recruiting | USA | 0 |
| NCT05239624 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer | 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 | 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 |
| 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) | Recruiting | USA | TUR | POL | NLD | ITA | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | AUS | 4 |
| 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 |
| 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 |
| 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) | Completed | USA | ROU | POL | ITA | ISR | HUN | HRV | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BGR | AUS | ARG | 12 |
| 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 |
| 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 |
| NCT07221942 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma | 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 |
| NCT07346053 | Phase III | Enfortumab vedotin-ejfv + Pembrolizumab | The Impact of Time-of-day Administration of EV/P on Objective Response Rate in Adults With Advanced Bladder Cancer (Chrono-EVP) | Not yet recruiting | CAN | 0 |
| NCT06302569 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma (REPRINT) | Recruiting | ITA | 0 |
| NCT06470282 | Phase Ib/II | Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive 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 |
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