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|Therapy Name||Enfortumab vedotin-ejfv + Pembrolizumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Enfortumab vedotin-ejfv||Padcev||AGS-22ME||Padcev (enfortumab vedotin-ejfv) is an antibody drug conjugate 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 (FDA.gov).|
|Pembrolizumab||Keytruda||MK-3475||Immune Checkpoint Inhibitor 141 PD-L1/PD-1 antibody 83||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, 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|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|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 | FRA | ESP | DEU | CAN||15|
|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 | FRA | ESP | DEU | CAN | BEL||16|
|NCT05239624||Phase II||Enfortumab vedotin-ejfv + Pembrolizumab||Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer||Not yet recruiting||USA||0|