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Metastatic Urothelial CarcinomaPhase 1/2NCT06483334

A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)

A Phase 1/2 study testing Sacituzumab tirumotecan, Enfortumab Vedotin and Pembrolizumab in people with Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, run by Merck Sharp & Dohme LLC at 25 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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 safety and preliminary efficacy of sacituzumab tirumotecan plus enfortumab vedotin (EV). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab tirumotecan, Enfortumab Vedotin and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
25 sitesin 10 countries
Study dates
17 Jul 2024to 31 Mar 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • Has Grade ≥2 peripheral neuropathy.
  • Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
Show all 19Show fewer
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease and/or serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
  • 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 a history of uncontrolled diabetes.
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
  • PART 2 ONLY: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before 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.
  • PART 2 ONLY: Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
  • Is human immunodeficiency virus (HIV)-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Has active Hepatitis B or Hepatitis C virus infection.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • PART 2 ONLY: History of allogeneic tissue/solid organ transplant.
  • Has not adequately recovered from major surgery or has ongoing surgical complications.

Trial locations and contacts

25 sites in 10 countries.

25 sites in 10 countries

United States8 sites

  • Dana-Farber Cancer Institute ( Site 4047)

    Boston, Massachusetts, 02115

  • University of Chicago Medical Center ( Site 4037)

    Chicago, Illinois, 60637

  • Cleveland Clinic-Taussig Cancer Center ( Site 4036)

    Cleveland, Ohio, 44195

  • Indiana University Melvin and Bren Simon Cancer Center ( Site 4011)

    Indianapolis, Indiana, 46202

  • Icahn School of Medicine at Mount Sinai ( Site 4018)

    New York, New York, 10029

  • Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 4041)

    Salt Lake City, Utah, 84112

  • University of California San Francisco HDFCCC ( Site 4044)

    San Francisco, California, 94158

  • Siteman Cancer Center ( Site 4038)

    St Louis, Missouri, 63108

Other trials in United States

Israel3 sites

  • Rambam Health Care Campus ( Site 4501)

    Haifa, 3109601

  • Rabin Medical Center-Oncology ( Site 4504)

    Petah Tikva, 4941492

  • Sheba Medical Center-ONCOLOGY ( Site 4503)

    Ramat Gan, 5265601

Other trials in Israel

Italy3 sites

  • Ospedale San Raffaele-Oncologia Medica ( Site 4403)

    Milan, Lombardy, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 4405)

    Milan, 20133

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 4406)

    Naples, 80131

Other trials in Italy

South Korea3 sites

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4903)

    Seoul, 03722

  • Asan Medical Center-Department of Oncology ( Site 4901)

    Seoul, 05505

  • Samsung Medical Center ( Site 4902)

    Seoul, 06351

Other trials in South Korea

Canada2 sites

  • The Ottawa Hospital - General Campus ( Site 4105)

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre ( Site 4106)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Spain2 sites

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 4767)

    Barcelona, 08035

  • Hospital Clinico San Carlos ( Site 4765)

    Madrid, 28040

Other trials in Spain

France1 site

  • Centre Hospitalier Lyon Sud ( Site 4606)

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69310

Other trials in France

Netherlands1 site

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 4302)

    Amsterdam, North Holland, 1066 CX

Other trials in Netherlands

Taiwan1 site

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 4803)

    Tainan, 704

Other trials in Taiwan

United Kingdom1 site

  • St Bartholomew s Hospital ( Site 4206)

    London, London, City of, EC1A 7BE

Other trials in United Kingdom

About this study

Official title: 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

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.

Read the detailed 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.

As of Amendment 5, Part 2 will not be conducted. No participants will be enrolled in Part 2, and no data for Part 2 will be collected.

Being tested
Sacituzumab tirumotecan, Enfortumab Vedotin, Pembrolizumab, Supportive care measures
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Medical subject headings
Carcinoma, Transitional Cell, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab tirumotecanBiological

    Also called MK-2870, SKB264

    IV infusion at different dose levels

  • Enfortumab VedotinBiological

    Also called PADCEV™

    IV infusion at different dose levels

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA

    200 mg IV infusion

  • Supportive care measuresDrug

    Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions.

Study groups in NCT06483334
Study groupRoleWhat they receive
Sacituzumab tirumotecan plus EVExperimentalParticipants 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.
Receives: Biological: Sacituzumab tirumotecan; Biological: Enfortumab Vedotin; Drug: Supportive care measures
Sacituzumab tirumotecan plus EV and pembrolizumabExperimentalParticipants 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).
Receives: Biological: Sacituzumab tirumotecan; Biological: Enfortumab Vedotin; Biological: Pembrolizumab; Drug: Supportive care measures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Percentage of Participants with Dose-limiting toxicities (DLT)

    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.

    Measured: Up to 21 days

  2. Part 1: Percentage of Participants Who Experienced At Least One Adverse Event (AE)

    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.

    Measured: Up to ~3 years

  3. Part 1: Percentage of Participants Who Discontinued Study Treatment Due to an AE

    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 treatment due to an AE in Part 1 will be reported.

    Measured: Up to ~2 years

  4. Part 2: Percentage of Participants with DLT

    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 NCI CTCAE 5.0. The number of participants who experience a DLT in Part 2 will be reported.

    Measured: Up to 21 days

  5. Part 2: Percentage of Participants Who Experienced At Least One AE

    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 2 will be reported.

    Measured: Up to ~3 years

  6. Part 2: Percentage of Participants Who Discontinued Study Treatment Due to an AE

    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 treatment due to an AE in Part 2 will be reported.

    Measured: Up to ~2 years

  7. Part 2: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) (disappearance of all target lesions) or partial response (PR) (at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator. ORR will be reported for participants in Part 2.

    Measured: Up to ~3 years

Secondary outcomes (27)

  1. Part 1: ORR

    ORR is defined as the percentage of participants who achieve a confirmed CR or PR per RECIST 1.1 as assessed by investigator. ORR will be reported for participants in Part 1.

    Measured: Up to ~3 years

  2. Part 2: Duration of Response (DOR)

    For participants who demonstrate confirmed CR or PR per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator will be presented.

    Measured: Up to ~3 years

  3. Part 1: Maximum Serum Concentration (Cmax) of Sacituzumab Tirumotecan-Antibody-Drug Conjugate (ADC)

    Blood samples collected at designated time points will be used to determine the Cmax of sacituzumab tirumotecan-ADC in Part 1.

    Measured: Days 1, 8, 15 of Cycle 1 (each cycle is 21 days), Day 1 of Cycle 2, Days 1 and 8 of Cycle 3, Day 1 of Cycles 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  4. Part 1: Serum Trough Concentration (Ctrough) of Sacituzumab Tirumotecan-ADC

    Blood samples collected at designated time points will be used to determine the Ctrough of sacituzumab tirumotecan-ADC in Part 1.

    Measured: Days 1, 8, 15 of Cycle 1 (each cycle is 21 days), Day 1 of Cycle 2, Days 1 and 8 of Cycle 3, Day 1 of Cycles 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  5. Part 1: Cmax of Free Payload for Sacituzumab Tirumotecan

    Blood samples collected at designated time points will be used to determine the Cmax of free payload for sacituzumab tirumotecan in Part 1.

    Measured: Days 1, 8, 15 of Cycle 1 (each cycle is 21 days), Day 1 of Cycle 2, Days 1 and 8 of Cycle 3, Day 1 of Cycles 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  6. Part 1: Ctrough of Free Payload for Sacituzumab Tirumotecan

    Blood samples collected at designated time points will be used to determine the Ctrough of free payload for sacituzumab tirumotecan in Part 1.

    Measured: Days 1, 8, 15 of Cycle 1 (each cycle is 21 days), Day 1 of Cycle 2, Days 1 and 8 of Cycle 3, Day 1 of Cycles 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  7. Part 1: Cmax of Enfortumab Vedotin-ADC

    Blood samples collected at designated time points will be used to determine the Cmax of enfortumab vedotin-ADC in Part 1.

    Measured: Days 1 and 8 of Cycle 1 (each cycle is 21 days), Day 1 of Cycle 2, Days 1 and 8 of Cycle 3, and Day 1 of Cycles 4 and 8

  8. Part 1: Ctrough of Enfortumab Vedotin-ADC

    Blood samples collected at designated time points will be used to determine the Ctrough of enfortumab vedotin-ADC in Part 1.

    Measured: Days 1 and 8 of Cycle 1 (each cycle is 21 days), Day 1 of Cycle 2, Days 1 and 8 of Cycle 3, and Day 1 of Cycles 4 and 8

  9. Part 1: Cmax of Free Payload for Enfortumab Vedotin

    Blood samples collected at designated time points will be used to determine the Cmax of free payload for EV in Part 1.

    Measured: Days 1, 8, 15 of Cycle 1 (each cycle is 21 days), Day 1 of Cycle 2, Days 1 and 8 of Cycle 3, and Day 1 of Cycles 4 and 8

  10. Part 1: Ctrough of Free Payload for Enfortumab Vedotin

    Blood samples collected at designated time points will be used to determine the Ctrough of free payload for EV in Part 1.

    Measured: Days 1, 8, 15 of Cycle 1 (each cycle is 21 days), Day 1 of Cycle 2, Days 1 and 8 of Cycle 3, and Day 1 of Cycles 4 and 8

  11. Part 1: Incidence of Antidrug Antibodies (ADA) to Sacituzumab Tirumotecan

    Blood samples collected at designated timepoints will be used to determine the ADA response to sacituzumab tirumotecan. The incidence of ADAs over time in Part 1 will be presented.

    Measured: Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  12. Part 1: Incidence of ADA to Enfortumab Vedotin

    Blood samples collected at designated timepoints will be used to determine the ADA response to sacituzumab tirumotecan. The incidence of ADAs over time in Part 1 will be presented.

    Measured: Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4 and 8

  13. Part 2: Cmax of Sacituzumab Tirumotecan-ADC

    Blood samples collected at designated time points will be used to determine the Cmax of sacituzumab tirumotecan-ADC in Part 2.

    Measured: Days 1 and 8 of Cycle 1 (each cycle is 21 days), Day 1 of Cycles 2, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  14. Part 2: Ctrough of Sacituzumab Tirumotecan-ADC

    Blood samples collected at designated time points will be used to determine the Ctrough of sacituzumab tirumotecan-ADC in Part 2.

    Measured: Days 1 and 8 of Cycle 1 (each cycle is 21 days), Day 1 of Cycles 2, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  15. Part 2: Cmax of Free Payload for Sacituzumab Tirumotecan

    Blood samples collected at designated time points will be used to determine the Cmax of free payload for sacituzumab tirumotecan in Part 2.

    Measured: Days 1 and 8 of Cycle 1 (each cycle is 21 days), Day 1 of Cycles 2, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  16. Part 2: Ctrough of Free Payload for Sacituzumab Tirumotecan

    Blood samples collected at designated time points will be used to determine the Ctrough of free payload for sacituzumab tirumotecan in Part 2.

    Measured: Days 1 and 8 of Cycle 1 (each cycle is 21 days), Day 1 of Cycles 2, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  17. Part 2: Cmax of Enfortumab Vedotin-ADC

    Blood samples collected at designated time points will be used to determine the Cmax of enfortumab vedotin-ADC in Part 2.

    Measured: Days 1 and 8 of Cycle 1 (each cycle is 21 days), Day 1 of Cycles 2, 4 and 8

  18. Part 2: Ctrough of Enfortumab Vedotin-ADC

    Blood samples collected at designated time points will be used to determine the Ctrough of enfortumab vedotin-ADC in Part 2.

    Measured: Days 1 and 8 of Cycle 1 (each cycle is 21 days), Day 1 of Cycles 2, 4 and 8

  19. Part 2: Cmax of Free Payload for Enfortumab Vedotin

    Blood samples collected at designated time points will be used to determine the Cmax of free payload for EV in Part 2.

    Measured: Days 1 and 8 of Cycle 1 (each cycle is 21 days), Day 1 of Cycles 2, 4 and 8

  20. Part 2: Ctrough of Free Payload for Enfortumab Vedotin

    Blood samples collected at designated time points will be used to determine the Ctrough of free payload for EV in Part 2.

    Measured: Days 1 and 8 of Cycle 1 (each cycle is 21 days), Day 1 of Cycles 2, 4 and 8

  21. Part 2: Cmax of Pembrolizumab-ADC

    Blood samples collected at designated time points will be used to determine the Cmax of pembrolizumab-ADC.

    Measured: Days 1 of Cycles 1 (each cycle is 21 days), 2, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  22. Part 2: Ctrough of Pembrolizumab-ADC

    Blood samples collected at designated time points will be used to determine the Ctrough of pembrolizumab-ADC.

    Measured: Days 1 of Cycles 1 (each cycle is 21 days), 2, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  23. Part 2: Cmax of Free Payload for Pembrolizumab

    Blood samples collected at designated time points will be used to determine the Cmax of free payload for pembrolizumab.

    Measured: Days 1 of Cycles 1 (each cycle is 21 days), 2, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  24. Part 2: Ctrough of Free Payload for Pembrolizumab

    Blood samples collected at designated time points will be used to determine the Ctrough of free payload for pembrolizumab.

    Measured: Days 1 of Cycles 1 (each cycle is 21 days), 2, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  25. Part 2: Incidence of ADA to Sacituzumab Tirumotecan

    Blood samples collected at designated timepoints will be used to determine the ADA response to sacituzumab tirumotecan. The incidence of ADAs over time in Part 2 will be presented.

    Measured: Day 1 of Cycles 1 (each cycle is 21 days), 2, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

  26. Part 2: Incidence of ADA to Enfortumab Vedotin

    Blood samples collected at designated timepoints will be used to determine the ADA response to EV. The incidence of ADAs over time in Part 2 will be presented.

    Measured: Day 1 of Cycles 1 (each cycle is 21 days), 2, 4 and 8

  27. Part 2: Incidence of ADA to Pembrolizumab

    Blood samples collected at designated timepoints will be used to determine the ADA response to pembrolizumab. The incidence of ADAs over time be presented.

    Measured: Day 1 of Cycles 1 (each cycle is 21 days), 2, 4 and 8 and every 4 cycles thereafter up to Cycle 35, at end of treatment, and at 30 days post last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2024
  2. Study start17 Jul 2024
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Part 1 is non-randomized open-label. Part 2 is randomized open-label (as of Amendment 5, Part 2 will not be conducted).
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06483334
Sponsor's protocol ID
3475-04C
Other IDs
MK-3475-04C, 2023-506387-14-00, U1111-1293-7631, 2023
Status last verified
Feb 2026
First submitted
21 Jun 2024
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sacituzumab tirumotecan, Enfortumab Vedotin and Pembrolizumab in people with Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, run by Merck Sharp & Dohme LLC at 25 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Israel, Italy, South Korea, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Percentage of Participants with Dose-limiting toxicities (DLT) (time frame: Up to 21 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06483334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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