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 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 115 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 SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-expressing NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemotherapy in NSCLC, 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 CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemotherapy for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, and in combination with chemoradiation for cervical 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
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 | ITA | GBR | FRA | ESP | CAN | AUS 5
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
NCT05239624 Phase II Enfortumab vedotin-ejfv + Pembrolizumab Enfortumab Vedotin and Pembrolizumab in People With Bladder 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) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 16
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 | ITA | GBR | FRA | ESP | DEU | CAN | AUS 21
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
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
NCT05923190 Phase II Enfortumab vedotin-ejfv Enfortumab vedotin-ejfv + Pembrolizumab Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma Recruiting USA 0
NCT05656235 Phase II Enfortumab vedotin-ejfv + Pembrolizumab Renal Retention in High Grade Upper Tract Urothelial Cancer Not yet recruiting USA 0


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