Livmoniplimab
DrugIntravenous (IV) Infusion
Other names: ABBV-151
NCT Number: NCT06632951
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 2
Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635, Québec, Quebec, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous (IV) Infusion
Other names: ABBV-151
IV Infusion
Other names: ABBV-181
IV Infusion
IV Injection
IV Infusion
Time frame: Up to Approximately 3.5 Years
OS is defined as the time measured from randomization until death from any cause.
Time frame: Up to Approximately 3.5 Years
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
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
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
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
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
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
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 (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.
Time frame: Up to Approximately 3.5 Years
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
Cmax is defined as the maximum observed serum concentration of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
Cmax is defined as the maximum observed serum concentration of budigalimab.
Time frame: Up to Approximately 3.5 Years
Tmax is defined as the time to reach Cmax of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
Tmax is defined as the time to reach Cmax of budigalimab.
Time frame: Up to Approximately 3.5 Years
AUC is defined as the area under the serum concentration versus time curve of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
AUC is defined as the area under the serum concentration versus time curve of budigalimab.
Time frame: Up to Approximately 3.5 Years
CL is defined as the Clearance of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
CL is defined as the Clearance of budigalimab.
Time frame: Up to Approximately 3.5 Years
Vd is defined as the volume of distribution of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
Vd is defined as the volume of distribution of budigalimab.
Time frame: Up to Approximately 3.5 Years
Incidence of anti-drug antibodies of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
Incidence of anti-drug antibodies of budigalimab.
Time frame: Up to Approximately 3.5 Years
Incidences of neutralizing anti-drug antibodies of livmoniplimab.
Time frame: Up to Approximately 3.5 Years
Incidences of neutralizing anti-drug antibodies of budigalimab.
AbbVie
Industry
A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma
Acronym: LIVIGNO-3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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