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Clinical Trials in the UK / NCT05845814
Active, not recruiting Phase 1/2

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)

NCT05845814 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 1/2
Started
2023-06-23
Last updated
2025-09-10

Condition(s) studied

Metastatic Urothelial CarcinomaUrothelial Neoplasms

Investigational drug(s) / intervention(s)

Coformulated favezelimab/pembrolizumabCoformulated vibostolimab/pembrolizumabEVPembrolizumab

Coformulated favezelimab/pembrolizumab: Coformulated favezelimab/pembrolizumab (800 mg/200 mg) IV infusion

Coformulated vibostolimab/pembrolizumab: Coformulated vibostolimab/pembrolizumab (200 mg/200 mg) IV infusion

EV: 1.25 mg/kg IV infusion

Pembrolizumab: 200 mg IV infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC). * Participants with mixed histology are eligible provided the urothelial component is ≥50% (and \<10% plasmacytoid component) * Participants whose tumors contain any neuroendocrine component are not eligible (variant histology to be confirmed locally) * Must not have received prior systemic therapy for la/mUC. The following therapies in earlier disease setting (eg, muscle-invasive urothelial carcinoma (MIUC)) are permitted: * Participants that received neoadjuvant or adjuvant chemotherapy are permitted. * Participants who received anti- programmed cell death 1 protein (PD-1) or programmed cell death ligand 1 (PD-L1) therapy for an earlier disease stage (eg, NMIBC, MIUC) with progression/recurrence \>12 months from completion of therapy are permitted. * Must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation. A newly obtained biopsy is strongly preferred, but not required if archival tissue is evaluable. * Any AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Endocrine-related AEs adequately treated with hormone replacement or with \<Grade 2 neuropathy are eligible. Exclusion Criteria: * Has a known additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy. * Central nervous system (CNS) metastases are permitted on-study if all of the following are true: a) CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis; b) the participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment); c) participant does not have leptomeningeal disease. * Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency. * Has active keratitis or corneal ulcerations. Superficial punctate keratitis is allowed if the disorder is being adequately treated in the opinion of the investigator. * Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy. * Has a history of uncontrolled diabetes. * Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis * Has an active infection (viral, bacterial, or fungal) requiring systemic therapy. * Has a known history of human immunodeficiency virus (HIV) infection. * Has hepatitis B or hepatitis C virus infection. * Has had major surgery within 4 weeks prior to first dose of study intervention. * Has had an allogenic tissue/solid organ transplant

Primary outcome measure(s)

Trial sites (47)

FacilityCityRegionStatus
Moores Cancer Center ( Site 3028) La Jolla California
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3045) Orange California
UCSF Medical Center at Mission Bay ( Site 3044) San Francisco California
Anschutz Cancer Pavilion ( Site 3017) Aurora Colorado
Emory University School of Medicine ( Site 3043) Atlanta Georgia
Indiana University Melvin and Bren Simon Cancer Center ( Site 3011) Indianapolis Indiana
Dana-Farber Cancer Institute ( Site 3047) Boston Massachusetts
Siteman Cancer Center ( Site 3038) St Louis Missouri
Icahn School of Medicine at Mount Sinai ( Site 3018) New York New York
Memorial Sloan Kettering Cancer Center ( Site 3031) New York New York
Duke Cancer Institute ( Site 3027) Durham North Carolina
Cleveland Clinic-Taussig Cancer Center ( Site 3036) Cleveland Ohio
UPMC Hillman Cancer Center ( Site 3014) Pittsburgh Pennsylvania
Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 3041) Salt Lake City Utah
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 3951) Brisbane Queensland
Austin Health-Cancer Clinical Trials Centre ( Site 3950) Heidelberg Victoria
The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 3105) Ottawa Ontario
Sunnybrook Research Institute - Odette Cancer Centre ( Site 3108) Toronto Ontario
Princess Margaret Cancer Centre ( Site 3106) Toronto Ontario
FALP-UIDO ( Site 3151) Santiago Region M. de Santiago
Bradfordhill-Clinical Area ( Site 3155) Santiago Region M. de Santiago
ONCOCENTRO APYS-ACEREY ( Site 3158) Viña del Mar Valparaiso
Bradford Hill Norte ( Site 3152) Antofagasta Chile
CHU de Bordeaux Hop St ANDRE ( Site 3607) Bordeaux Aquitaine
Centre Georges François Leclerc-Centre de recherche clinique ( Site 3608) Dijon Cote-d Or
Oncopole Claudius Regaud ( Site 3610) Toulouse Haute-Garonne
centre hospitalier lyon sud ( Site 3606) Pierre-Bénite Rhone
Hôpital Européen Georges Pompidou ( Site 3605) Paris France
Rambam Health Care Campus-Oncology Division ( Site 3501) Haifa Israel
Rabin Medical Center-Oncology ( Site 3504) Petah Tikva Israel
Sheba Medical Center-ONCOLOGY ( Site 3503) Ramat Gan Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3406) Naples Campania
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3405) Milan Lombardy
Ospedale San Raffaele-Oncologia Medica ( Site 3403) Milan Italy
Maastricht UMC+ ( Site 3304) Maastricht Limburg
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 3302) Amsterdam North Holland
Erasmus Medisch Centrum-Medical Oncology ( Site 3303) Rotterdam South Holland
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3903) Seoul South Korea
Asan Medical Center-Department of Oncology ( Site 3901) Seoul South Korea
Samsung Medical Center ( Site 3902) Seoul South Korea

+ 7 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05845814 on ClinicalTrials.gov ↗ ← All trials in the UK