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)
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)
Part 1: Objective Response Rate (ORR) — Up to ~4 years ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). ORR will be reported for participants in Part 1.
Part 1: Percentage of Participants experiencing an Adverse Event (AE) — Up to ~4 years An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants experiencing an AE in Part 1 will be reported.
Part 1: Percentage of Participants who Discontinue study interventions due to an AE — Up to ~4 years An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinue study interventions due to an AE in Part 1 will be reported.
Part 1: Percentage of Participants with Dose-limiting toxicities (DLT) — Up to 21 days A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0). The number of participants who experience a DLT in Part 1 will be reported.
Part 2: Progression Free Survival (PFS) — Up to ~4 years PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PFS will be reported for participants in Part 2.
Trial sites (47)
Facility
City
Region
Status
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.
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.
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