A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
NCT ID: NCT05562830
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2022-11-16
2028-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Zilovertamab vedotin
Participants will receive zilovertamab vedotin 2mg/kg administered on Day 1 and Day 8 of each 3 week cycle (Q3W) until documented disease progression or any other discontinuation criterion is met.
Zilovertamab vedotin
Administered via intravenous (IV) infusion on day 1 and day 8 of Q3W cycles
Arm B: Pembrolizumab and MK-3120
Participants will receive MK-3120 up to 5mg/kg administered on Day 1, Day 15 and Day 29 of each 6 week cycle until documented disease progression or any other discontinuation criterion is met and 400mg pembrolizumab on Day 1 of each 6 week cycle for up to 17 cycles (up to \~2 years).
Pembrolizumab
Administered via IV infusion on Day 1 of each 6 week cycle.
MK-3120
Administered as an IV infusion on Day 1, Day 15, and Day 29 of each 6 week cycle.
Interventions
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Zilovertamab vedotin
Administered via intravenous (IV) infusion on day 1 and day 8 of Q3W cycles
Pembrolizumab
Administered via IV infusion on Day 1 of each 6 week cycle.
MK-3120
Administered as an IV infusion on Day 1, Day 15, and Day 29 of each 6 week cycle.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Arm A: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease progression while on treatment or after treatment with an anti-PD-1/L1 monoclonal antibody (mAb) for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies OR disease recurrence while on treatment or after treatment with an anti-PD-1/L1 mAb for muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy.
* Arm A: Participants 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.
* Arm B: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease progression after treatment with an anti-PD-1/L1 mAb for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies; OR disease recurrence after treatment with an anti-PD-1/L1 mAb for MIUC administered as monotherapy or in combination with other checkpoint therapies \>12 months after last dose of treatment with an anti-PD-1/L1 mAb.
* Arm B: Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion from a metastatic site or from a primary tumor that has become locally advanced and not previously irradiated.
* Known additional nonurothelial malignancy that is progressing or has required active treatment within 3 years prior to study randomization/allocation.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
* Active infection requiring systemic therapy.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Known history of human immunodeficiency virus (HIV).
* Known history of hepatitis B or known hepatitis C virus infection.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045)
Orange, California, United States
Anschutz Cancer Pavilion ( Site 1017)
Aurora, Colorado, United States
University of Chicago Medical Center ( Site 1037)
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 1011)
Indianapolis, Indiana, United States
Siteman Cancer Center ( Site 1038)
St Louis, Missouri, United States
Cleveland Clinic-Taussig Cancer Center ( Site 1036)
Cleveland, Ohio, United States
UPMC Hillman Cancer Center ( Site 1014)
Pittsburgh, Pennsylvania, United States
Huntsman Cancer Institute ( Site 1041)
Salt Lake City, Utah, United States
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 1952)
Brisbane, Queensland, Australia
FALP-UIDO ( Site 1151)
Santiago, Region M. de Santiago, Chile
Bradford Hill ( Site 1155)
Santiago, Region M. de Santiago, Chile
Rigshospitalet-Dept. of Oncology ( Site 1701)
Copenhagen, Capital Region, Denmark
Rambam Health Care Campus-Oncology ( Site 1501)
Haifa, , Israel
Rabin Medical Center-Oncology ( Site 1504)
Petah Tikva, , Israel
Sheba Medical Center-ONCOLOGY ( Site 1503)
Ramat Gan, , Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1406)
Napoli, , Italy
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1302)
Amsterdam, North Holland, Netherlands
Severance Hospital, Yonsei University Health System ( Site 1903)
Seoul, , South Korea
Asan Medical Center ( Site 1901)
Seoul, , South Korea
Samsung Medical Center ( Site 1902)
Seoul, , South Korea
Hospital Universitari Vall d'Hebron ( Site 1767)
Barcelona, Catalonia, Spain
Hospital Clinico San Carlos ( Site 1765)
Madrid, , Spain
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1201)
London, London, City of, United Kingdom
Countries
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Related Links
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Merck Oncology Clinical Trials Information
Protocol Plain Language Summary
Other Identifiers
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MK-3475-04A
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506384-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1293-7548
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-004544-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-04A
Identifier Type: -
Identifier Source: org_study_id