A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)

Phase 3Not Yet RecruitingNCT07829783

Merck Sharp & Dohme LLC400 enrolled

Overview

Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body. The usual treatment for MIBC is surgery to remove the bladder but some people choose to have other treatments, such as chemoradiotherapy (CRT), instead of surgery so they can keep their bladder. Researchers want to know if giving 2 trial treatments with CRT can treat MIBC. One trial treatment is called sacituzumab tirumotecan (sac-TMT) and the other trial treatment is called subcutaneous (SC) pembrolizumab (or pembrolizumab and berahyaluronidase alfa). The main goal of this trial is to learn if participants who receive sac-TMT, SC pembrolizumab, and CRT live longer without their cancer growing, spreading, or coming back compared to those who receive CRT alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Bladder Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a diagnosis of muscle-invasive bladder cancer (MIBC) (cT2-T4aN0-N1) * Has clinically nonmetastatic bladder cancer (N0-N1M0) * Is either ineligible for radical cystectomy or has opted for bladder preservation and is planned to receive chemoradiotherapy (CRT) * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has known presence of diffuse carcinoma in situ (CIS) throughout the bladder * 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 * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has received prior pelvic/local radiation therapy for any reason or any systemic antineoplastic treatment for MIBC * Has not recovered to Grade ≤1 or baseline from AE associated with anticancer therapy before randomization * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments

Outcomes

Primary Outcomes

Event-Free Survival (EFS)

EFS is defined as the time from randomization to the first occurrence of any of the following events, as assessed by blinded independent central review (BICR): residual/recurrent MIBC, or locoregional disease, or distant metastases as assessed by imaging and/or biopsy results, or death from any cause. The EFS for all participants will be presented.

Time frame: Up to approximately 60 months

Secondary Outcomes

Overall Survival (OS)

OS is defined as the time from randomization to death due to any cause. The OS for all participants will be presented.