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Therapy Name | Enfortumab vedotin-ejfv + Pembrolizumab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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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 146 PD-L1/PD-1 antibody 109 | 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, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous squamous cell carcinoma, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, cervical cancer, and triple-negative breast cancer, in combination with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, 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 chemotherapy for patients with esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma, and in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer (FDA.gov). |
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 |
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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 |
NCT05656235 | Phase II | Enfortumab vedotin-ejfv + Pembrolizumab | Renal Retention in High Grade Upper Tract Urothelial Cancer | 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) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 21 |
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) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 16 |
NCT05923190 | Phase II | Enfortumab vedotin-ejfv Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma | 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) | Recruiting | USA | FRA | AUS | 5 |
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 | 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 | 0 |