Summary
Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the
treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains
a high unmet need for effective therapies for participants who have recurrent disease and
disease that has progressed after frontline treatment. The purpose of this study is to
evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination
with budigalimab.
Livmoniplimab is an investigational drug being developed for the treatment of mUC. There
are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio.
Participants will either receive livmoniplimab (at one of 2 different doses) in
combination with budigalimab (another investigational drug), or either docetaxel,
paclitaxel, or gemcitabine (based on investigator's choice). Approximately 150 adult
participants will be enrolled in the study across 56 sites worldwide.
In arm 1, participants will receive intravenously (IV) infused livmoniplimab (dose A) in
combination with IV infused budigalimab. In arm 2, participants will receive IV infused
livmoniplimab (dose B) in combination with IV infused budigalimab. In arm 3 (control),
participants will receive the investigator's choice: IV infused or injected docetaxel; IV
infused or injected paclitaxel; or IV infused gemcitabine. The estimated duration of the
study is up to approximately 3.5 years.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital
or clinic and may require frequent medical assessments, blood tests, questionnaires, and
scans.