A Phase 2 interventional study of Livmoniplimab and Budigalimab in Urothelial Carcinoma, sponsored by AbbVie. Active, not recruiting at 37 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.
This study's planned enrollment of 150 is above the median of 49 across 549 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participant has received more than 1 prior chemotherapy regimen for urothelial cancer in metastatic setting, including chemotherapy agents planned in comparator arm.
Participants will receive livmoniplimab (dose A) in combination with budigalimab, as part of the approximately 3.5 years study duration.
Drug: Livmoniplimab · Drug: Budigalimab
Participants will receive livmoniplimab (dose B) in combination with budigalimab, as part of the approximately 3.5 years study duration.
Drug: Livmoniplimab · Drug: Budigalimab
Participants will receive docetaxel, paclitaxel, or gemcitabine, investigator's choice, as part of the approximately 3.5 years study duration.
Drug: Docetaxel · Drug: Paclitaxel · Drug: Gemcitabine
Intravenous (IV) Infusion
Also known as: ABBV-151
IV Infusion
Also known as: ABBV-181
IV Infusion
IV Injection
IV Injection
IV Infusion
IV Infusion
Overall Survival (OS)
OS is defined as the time measured from randomization until death from any cause.
Time frame: Up to Approximately 3.5 Years
Progression-Free survival (PFS)
PFS is defined as the time measured from randomization until the first documentation of progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by investigators or death from any cause, whichever occurs first.
Time frame: Up to Approximately 3.5 Years
Best Overall Response (BOR) per Investigator
BOR is defined as achieving complete response (CR) or partial response (PR) according to RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.
Time frame: Up to Approximately 3.5 Years
Duration of Response (DOR) per Investigator
DOR id defined as the time from first CR/PR until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Adverse Events (AE)s
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Serious Adverse Events (SAE)s
An SAE is defined as an AE that results in the death of the participant, threat to the participant's life, hospitalization, congenital abnormality, persistent or significant disability/incapacitation, or medical event requiring medical or surgical interventions to prevent a serious outcome.
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s
The treatment-emergent period is defined as time from the date of the first dose of study drug up to 90 days after the date of the last dose of study drug, or the first date starting new anticancer therapy, whichever occurs earlier. TEAEs include all AEs that occurred or worsened during the treatment emergent period and all treatment related SAEs as assessed by investigators.
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Vital signs are defined as systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Clinically Significant Laboratory Values
Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Immune-Related Reactions as AEs of Special Interest
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 3.5 Years
Maximum Observed Serum Concentration (Cmax) of Livmoniplimab
Cmax is defined as the maximum observed serum concentration of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
Cmax of Budigalimab
Cmax is defined as the maximum observed serum concentration of budigalimab.
Time frame: Up to Approximately 3.5 Years
Time to Reach Cmax (Tmax) of Livmoniplimab
Tmax is defined as the time to reach Cmax of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
Tmax of Budigalimab
Tmax is defined as the time to reach Cmax of budigalimab.
Time frame: Up to Approximately 3.5 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab
AUC is defined as the area under the serum concentration versus time curve of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
AUC of Budigalimab
AUC is defined as the area under the serum concentration versus time curve of budigalimab.
Time frame: Up to Approximately 3.5 Years
Clearance (CL) of Livmoniplimab
CL is defined as the Clearance of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
CL of Budigalimab
CL is defined as the Clearance of budigalimab.
Time frame: Up to Approximately 3.5 Years
Volume of Distribution (Vd) of Livmoniplimab
Vd is defined as the volume of distribution of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
Vd of Budigalimab
Vd is defined as the volume of distribution of budigalimab.
Time frame: Up to Approximately 3.5 Years
Incidence of Anti-Drug Antibodies (ADAs) of Livmoniplimab
Incidence of anti-drug antibodies of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
ADAs of Budigalimab
Incidence of anti-drug antibodies of budigalimab.
Time frame: Up to Approximately 3.5 Years
Incidences of Neutralizing Anti-Drug Antibodies (nADAs) of Livmoniplimab
Incidences of neutralizing anti-drug antibodies of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
Incidences of nADAs of Budigalimab
Incidences of neutralizing anti-drug antibodies of budigalimab.
Time frame: Up to Approximately 3.5 Years
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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