Therapy Detail
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| Therapy Name | Enfortumab vedotin-ejfv |
| Synonyms | |
| Therapy Description |
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). |
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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). |
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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 |
|---|---|---|---|---|---|---|
| NCT06311214 | Phase II | Trastuzumab deruxtecan Enfortumab vedotin-ejfv Sacituzumab govitecan-hziy | Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial) | Recruiting | USA | 0 |
| NCT05097599 | Phase II | Binimetinib + Encorafenib Trastuzumab deruxtecan Enfortumab vedotin-ejfv Talazoparib Lorlatinib | Strata PATH (Precision Indications for Approved Therapies) (Strata PATH) | Terminated | USA | 0 |
| NCT05014139 | Phase I | Enfortumab vedotin-ejfv | A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC) | Terminated | USA | GBR | FRA | ESP | DEU | CAN | 0 |
| NCT04225117 | Phase II | Enfortumab vedotin-ejfv | A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) | Active, not recruiting | USA | CAN | 1 |
| NCT06434350 | Phase Ib/II | Enfortumab vedotin-ejfv | Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE) | Recruiting | USA | 0 |
| NCT03474107 | Phase III | Enfortumab vedotin-ejfv Docetaxel + Paclitaxel + Vinflunine | A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DNK | DEU | CHE | CAN | BEL | AUT | AUS | ARG | 5 |
| NCT06104618 | Phase II | Enfortumab vedotin-ejfv | Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis | Recruiting | USA | 0 |
| NCT06553885 | Phase II | Enfortumab vedotin-ejfv | Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC | 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 |
| NCT03219333 | Phase II | Enfortumab vedotin-ejfv | A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer (EV-201) | Completed | USA | NLD | ITA | FRA | ESP | DEU | 2 |
| NCT05868265 | Phase II | Enfortumab vedotin-ejfv | A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract | Recruiting | USA | 0 |
| NCT02091999 | Phase I | Enfortumab vedotin-ejfv | A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4 | Completed | USA | CAN | 0 |
| NCT04754191 | Phase II | Enfortumab vedotin-ejfv | Enfortumab Vedotin as Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer (ENCORE) | Recruiting | USA | 0 |
| NCT05915351 | Phase II | Enfortumab vedotin-ejfv | Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC) | Active, not 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 |
| NCT06891560 | Phase II | Enfortumab vedotin-ejfv | A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma | Recruiting | USA | 0 |
| NCT07139977 | Phase II | Enfortumab vedotin-ejfv | Study of EV for Recurrent Endometrial Carcinoma (EV-4-EC) | Not yet recruiting | USA | 0 |
| NCT06394570 | Phase Ib/II | Enfortumab vedotin-ejfv | Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer (STAR-EV) | Recruiting | USA | 0 |
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