KEYNOTE-A39 : NCT04223856: Phase 3: Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302)

First Posted	2020-01-10
Trial status	Active, not recruiting
Sponsor	Astellas Pharma Global Development, Inc.
Abstract Presentation	Survival Benefit of Enfortumab Vedotin and Pembrolizumab Compared with Chemotherapy in Patients with Previously Untreated Locally Advanced or Metastatic Urothelial Cancer ESMO - 11 Mar 2024 Click here for details
Peer-reviewed journal publication	Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer March 6, 2024 - N Engl J Med PUBMED NEJM Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer  J Clin Oncol . 2023 Jan 1 PUBMED JCO
Press Release	Merck Announces Phase 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer  September 22, 2023 Click here for details PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer Friday, December 15, 2023 Click here for details
FDA	FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer December 15, 2023 Click here for details
NCCN	BLA77

KEYNOTE-A39 : NCT04223856: Phase 3: Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302)

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alon in Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302)

Official Title:

An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

Intervention / Treatment:

Drug: Enfortumab vedotin

Drug: Pembrolizumab

Drug: Cisplatin

Drug: Carboplatin

Drug: Gemcitabine

Other Study ID Numbers:

SGN22E-003

2019-004542-15 ( EudraCT Number )

MK-3475-A39 ( Other Identifier ) (OTHER: Merck)

KEYNOTE KN-A39 ( Other Identifier ) (OTHER: Merck)

jRCT2031200284 ( Registry Identifier ) (REGISTRY: Japan Registry of Clinical Trials (jRCT))

CTR20220974 ( Other Identifier ) (OTHER: ChinaDrugTrials.org.cn)

ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT04223856