Urothelial Carcinoma
Conditions
Interventions
-Arm 1: Livmoniplimab (Dose A) + Budigalimab
-Arm 2: Livmoniplimab (Dose B) + Budigalimab
-Arm 3: investigator's choice: Docetaxel, Paclitaxel, or Gemcitabine
Sponsors
Chika Yamagishi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Progression-Free survival (PFS) -Best Overall Response (BOR) per Investigator -Duration of Response (DOR) per Investigator | — |
Countries
Japan, United States
Contacts
Public ContactContact for Patients and HCP
AbbVie G.K.
Outcome results
None listed