Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC)
Bladder Cancer
Kidney Cancer
Unknown Primary
Ureter Cancer
Urethral Cancer
18 Years and older, Male and Female
M25-204 (primary)
NCI-2024-10299
2024-515506-11-00
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.
Eligibility
- 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.
Treatment Sites in Georgia
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