EV-103

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer

Phase

Phase 1/Phase 2

Status

Terminated

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Urologic Neoplasms; Renal Pelvis Neoplasms; Urothelial Cancer; Ureteral Neoplasms; Urethral Neoplasms

Interventions

enfortumab vedotin (EV); pembrolizumab; cisplatin; carboplatin; gemcitabine

Arms

• EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L · Experimental
• Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L · Experimental
• Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L · Experimental
• Cohort D: Enfortumab Vedotin + Cisplatin in 1L · Experimental
• Cohort E: Enfortumab Vedotin + Carboplatin in 1L · Experimental
• Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L · Experimental
• Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L · Experimental
• Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting · Experimental
• Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting · Experimental
• Randomized Cohort K: Enfortumab Vedotin Monotherapy · Experimental
• Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab · Experimental
• Cohort L: Enfortumab vedotin in MIBC in perioperative setting · Experimental

Enrollment

348

Primary outcomes

• Type, incidence, severity, seriousness, and relatedness of adverse events (Dose escalation and Expansion Parts 1 to 3 cohorts only)
• Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3 cohorts only)
• Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) (Cohort K only)
• Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only)

Sponsor

Astellas Pharma Global Development, Inc. with Merck Sharp & Dohme LLC, Seagen Inc.

Start

Oct 11, 2017

Primary completion

Feb 20, 2026

Results posted

No

Registry record

NCT03288545 · updated Mar 24, 2026

• Milowsky MI, O'Donnell PH, Hoimes CJ, Petrylak DP, Flaig TW, Moon HH, Friedlander TW, Mar N, McKay RR, Srinivas S, Gravis G, Ramamurthy C, Bupathi M, Bracarda S, Wright P, Hepp Z, Carret AS, Yu Y, Dillon R, Kataria R, Beaumont JL, Purnajo I, Rosenberg JE. Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab. J Clin Oncol. 2024 Apr 20;42(12):1403-1414. doi: 10.1200/JCO.23.01547. Epub 2024 Jan 12. PubMed 38215355
• O'Donnell PH, Milowsky MI, Petrylak DP, Hoimes CJ, Flaig TW, Mar N, Moon HH, Friedlander TW, McKay RR, Bilen MA, Srinivas S, Burgess EF, Ramamurthy C, George S, Geynisman DM, Bracarda S, Borchiellini D, Geoffrois L, Maroto Rey JP, Ferrario C, Carret AS, Yu Y, Guseva M, Homet Moreno B, Rosenberg JE. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. J Clin Oncol. 2023 Sep 1;41(25):4107-4117. doi: 10.1200/JCO.22.02887. Epub 2023 Jun 27. PubMed 37369081
• Hoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer. J Clin Oncol. 2023 Jan 1;41(1):22-31. doi: 10.1200/JCO.22.01643. Epub 2022 Aug 30. PubMed 36041086