A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-... | NCT07419295

NCT07419295

ID	Type	Description
U1111-1316-4390	Registry Identifier	UTN
2024-520014-22-00	Registry Identifier	EU CT
MK-2870-031	Other Identifier	MSD
jRCT2051260020	Registry Identifier	Japan Registry of Clinical Trial (jRCT)

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sacituzumab tirumotecan	Experimental	Participants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity.	Biological: Sacituzumab tirumotecan Drug: Rescue medications for sacituzumab tirumotecan
Chemotherapy	Active Comparator	Participants receive paclitaxel 175 mg/m^2, docetaxel 75 mg/m^2, or vinflunine 320 mg/m^2 IV every 3 weeks (Q3W), at the investigator's discretion, until disease progression or unacceptable toxicity.	Drug: Vinflunine Drug: Docetaxel Drug: Paclitaxel Drug: Rescue medications for chemotherapy

Name	Type	Description	Arm Group Labels	Other Names
Sacituzumab tirumotecan	Biological	IV infusion	Sacituzumab tirumotecan

Outcomes Module

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as time from randomization to death due to any cause.	Up to approximately 40 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥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 ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator will be presented.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment
Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator
Has received treatment with anti-programmed cell death [ligand] 1 (anti-PD-[L]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV)
Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry
Has received a maximum of 2 prior lines of therapy
Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine)
Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated
If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART)
If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load
If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
Has adequate organ function

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

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 uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from adverse event (AE) associated with anticancer therapy
Has received prior therapy with trophoblast cell-surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC)
Has received prior therapy with a topoisomerase 1 inhibitor-containing ADC
Has completed prior external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
Has received prior chemotherapy for urothelial cancer with any of the study therapies in the control arm (paclitaxel, docetaxel, and vinflunine)
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 to the first dose of study intervention
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has a current or past history of central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring systemic therapy other than those permitted per protocol
Has a history of stem cell/solid organ transplant
Has not adequately recovered from major surgery, or has ongoing surgical complications

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

ID	Term
C111217	vinflunine
D000077143	Docetaxel
D017239	Paclitaxel
D004358	Drug Therapy

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D013812	Therapeutics