[M25-204]A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma

JRCT ID: jRCT2021240039

Registered date:02/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Urothelial Carcinoma
• Date of first enrollment: 10/01/2025
• Target sample size: 150
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

-Arm 1: Livmoniplimab (Dose A) + Budigalimab
-Arm 2: Livmoniplimab (Dose B) + Budigalimab
-Arm 3: investigator's choice: Docetaxel, Paclitaxel, or Gemcitabine

Outcome(s)

• Primary Outcome: Overall Survival (OS)

Secondary Outcome

-Progression-Free survival (PFS)
-Best Overall Response (BOR) per Investigator
-Duration of Response (DOR) per Investigator

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Participant has histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Mixed histologic types are allowed if urothelial (transitional cell) is the predominant histology.
-Participant has radiologically documented metastatic disease.
-Participant must have experienced radiographic progression or relapse on checkpoint inhibitor (anti-programmed cell death protein 1 [PD-1] or anti-programmed death-ligand 1 [PD-L1]) in the metastatic, adjuvant, or neo-adjuvant setting. Participant must have received at least 2 cycles of anti-PD-1 or anti-PD-L1.
-Participants eligible for platinum must have received a platinum containing regimen (cisplatin or carboplatin) in the metastatic, locally advanced, neoadjuvant, or adjuvant setting. If platinum was administered in the neoadjuvant or adjuvant setting, participant must have progressed within 6 months of completion of treatment. Platinum ineligible participants may enroll in this study without receiving a platinum containing regimen.
-Participant has at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by investigator.
-Life expectancy must be at least 3 months.

Exclude criteria

-Participant has received more than 1 prior chemotherapy regimen for urothelial cancer in metastatic setting, including chemotherapy agents planned in comparator arm.
-Participant has received more than 1 antibody-drug conjugate (ADC) in metastatic setting.
-Has had prior radiation therapy within 28 days prior to first dose of study drug or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to radiotherapy.
-History of additional malignancy or history of prior malignancy, except for adequately treated basal or squamous skin cancer, or cervical carcinoma in situ without evidence of disease, or malignancy treated with curative intent and with no evidence of disease recurrence for 5 years since the initiation of that therapy.
-Prior allogeneic stem cell or solid organ transplantation.

Related Information

• Primary Sponsor: Chika Yamagishi
• Secondary ID(s): NCT06632951