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, and in combination with Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy (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 | 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). |
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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 |
|---|---|---|---|---|---|---|
| NCT05915351 | Phase II | Enfortumab vedotin-ejfv | Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC) | Recruiting | USA | 0 |
| NCT05097599 | Phase II | Binimetinib + Encorafenib Trastuzumab deruxtecan Enfortumab vedotin-ejfv Talazoparib Lorlatinib | Strata PATH (Precision Indications for Approved Therapies) (Strata PATH) | Active, not 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 |
| NCT05014139 | Phase I | Enfortumab vedotin-ejfv | A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC) | Recruiting | USA | GBR | FRA | ESP | DEU | CAN | 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 |
| NCT05923190 | Phase II | Enfortumab vedotin-ejfv Enfortumab vedotin-ejfv + Pembrolizumab | Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma | Recruiting | USA | 0 |
| NCT06553885 | Phase II | Enfortumab vedotin-ejfv | Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC | 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 |
| NCT06434350 | Phase Ib/II | Enfortumab vedotin-ejfv | Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE) | Suspended | 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 |
| 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 |
| NCT05868265 | Phase II | Enfortumab vedotin-ejfv | A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract | Recruiting | USA | 0 |
| NCT04754191 | Phase II | Enfortumab vedotin-ejfv | Enfortumab Vedotin as Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer (ENCORE) | Recruiting | USA | 0 |
| 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 |
| 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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