A Phase 1/2 Randomized, Umbrella Study to Evaluate the Efficacy and Safety of MK-2870 Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab, as Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04C
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 safety and preliminary efficacy of sacituzumab tirumotecan plus enfortumab vedotin (EV). Part 2 will be based on Part 1 results and will evaluate the efficacy, pharmacokinetics, and safety of sacituzumab tirumotecan plus EV in combination with pembrolizumab in participants with advanced urothelial carcinoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC).
• 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 are eligible.
• PART 1 ONLY: Participants must have received platinum-based chemotherapy for treatment of la/mUC.
• PART 1 ONLY: Participants must not have received \>2 lines of therapy for la/mUC. Platinum-based chemotherapy followed by avelumab maintenance is considered 2 lines of therapy.
• PART 2 ONLY: Participants must not have received prior systemic therapy for la/mUC.
Locations
United States
California
University of California San Francisco HDFCCC ( Site 4044)
RECRUITING
San Francisco
Illinois
University of Chicago Medical Center ( Site 4037)
RECRUITING
Chicago
Indiana
Indiana University Melvin and Bren Simon Cancer Center ( Site 4011)
RECRUITING
Indianapolis
Massachusetts
Dana-Farber Cancer Institute ( Site 4047)
ACTIVE_NOT_RECRUITING
Boston
Missouri
Siteman Cancer Center ( Site 4038)
RECRUITING
St Louis
New York
Icahn School of Medicine at Mount Sinai ( Site 4018)
RECRUITING
New York
Ohio
Cleveland Clinic-Taussig Cancer Center ( Site 4036)
RECRUITING
Cleveland
Utah
Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 4041)
RECRUITING
Salt Lake City
Other Locations
Canada
The Ottawa Hospital - General Campus ( Site 4105)
RECRUITING
Ottawa
Princess Margaret Cancer Centre ( Site 4106)
RECRUITING
Toronto
France
Centre Hospitalier Lyon Sud ( Site 4606)
RECRUITING
Pierre-bénite
Israel
Rambam Health Care Campus ( Site 4501)
RECRUITING
Haifa
Rabin Medical Center-Oncology ( Site 4504)
RECRUITING
Petah Tikva
Sheba Medical Center-ONCOLOGY ( Site 4503)
RECRUITING
Ramat Gan
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 4405)
RECRUITING
Milan
Ospedale San Raffaele-Oncologia Medica ( Site 4403)
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 4406)
RECRUITING
Napoli
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 4302)
RECRUITING
Amsterdam
Republic of Korea
Asan Medical Center-Department of Oncology ( Site 4901)
RECRUITING
Seoul
Samsung Medical Center ( Site 4902)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4903)
RECRUITING
Seoul
Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 4767)
RECRUITING
Barcelona
Hospital Clinico San Carlos ( Site 4765)
RECRUITING
Madrid
Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 4803)
RECRUITING
Tainan City
United Kingdom
St Bartholomew s Hospital ( Site 4206)
RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date:2024-07-17
Estimated Completion Date:2028-07-28
Participants
Target number of participants:98
Treatments
Experimental: Sacituzumab tirumotecan plus EV
Participants will receive sacituzumab tirumotecan as an intravenous (IV) infusion and EV as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision.
Experimental: Sacituzumab tirumotecan plus EV and pembrolizumab
Participants will receive sacituzumab tirumotecan as an IV infusion and EV as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision. Participants will also receive pembrolizumab 200 mg as an IV infusion on Day 1 of every 3-week cycle for up to \~2 years (35 cycles).