Clinical Trials Logo
  1. Home
  2. Metastatic Urothelial Carcinoma
  3. NCT05845814

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)

Metastatic Urothelial Carcinoma Clinical Trial

Official title:
A Phase 1/2 Randomized, Umbrella Study to Evaluate the Safety and Efficacy of Pembrolizumab Plus Enfortumab Vedotin (EV) in Combination With Investigational Agents Versus Pembrolizumab Plus EV, as First-Line Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04B

Clinical Trial Summary

This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the efficacy and safety of coformulated favezelimab/pembrolizumab plus EV and coformulated vibostolimab/pembrolizumab plus EV relative to pembrolizumab plus EV. There will be no comparison of coformulated favezelimab/pembrolizumab plus EV versus coformulated vibostolimab/pembrolizumab plus EV. If ORR and/or DRR are substantially better on coformulated favezelimab/pembrolizumab plus EV and/or coformulated vibostolimab/pembrolizumab plus EV compared with pembrolizumab plus EV, after evaluation of the totality of data, the sponsor might consider Part 2 (expansion) to further characterize the efficacy and safety of the treatment arms under study.

Clinical Trial Description

The master study for this substudy is MK-3475-U04/KEYMAKER-U04. The master study will not be screening any participants and will not be registered. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05845814
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date June 23, 2023
Completion date May 31, 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT05700344 - SOGUG-AVELUMAB_RWD
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Recruiting NCT04953104 - Nivolumab for the Treatment of Patients With Metastatic Urothelial Cancer With ARID1A Mutation and Stratify Response Based on CXCL13 Expression Phase 2
Withdrawn NCT06050954 - A Pilot Study of Circulating Tumor DNA Adaptive Risk Maintenance Approach for Bladder Cancer (CARMA) Phase 2
Active, not recruiting NCT03534804 - Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma Phase 2
Active, not recruiting NCT00365157 - Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction Phase 1/Phase 2
Withdrawn NCT06018116 - A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer. Phase 2
Recruiting NCT05544552 - Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations Phase 1/Phase 2
Recruiting NCT04936230 - Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Terminated NCT05052372 - Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib
Terminated NCT03115801 - A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers Phase 2
Active, not recruiting NCT03854474 - Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma Phase 1/Phase 2
Terminated NCT02693717 - Pemetrexed Disodium in Treating Patients With Previously Treated Metastatic Urothelial Cancer Phase 2
Recruiting NCT04848519 - Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma Phase 2
Active, not recruiting NCT04724018 - Sacituzumab Govitecan Plus EV in Metastatic UC Phase 1
Terminated NCT04003610 - Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) Phase 2
Recruiting NCT04383067 - A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Urothelial Carcinoma Patients Phase 2
Not yet recruiting NCT03108261 - Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations Phase 2