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)

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
AbbVie
Study ID
NCT06632951
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Livmoniplimab — DRUG
    Intravenous (IV) Infusion
  • Budigalimab — DRUG
    IV Infusion
  • Docetaxel — DRUG
    IV Infusion
  • Paclitaxel — DRUG
    IV Injection
  • Docetaxel — DRUG
    IV Injection
  • Paclitaxel — DRUG
    IV Infusion
  • Gemcitabine — DRUG
    IV Infusion

Study Details

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.

Key Dates

Start date
Jan 20, 2025
Status verified
Aug 2025
Primary completion
Mar 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Livmoniplimab (Dose A) + Budigalimab
    Participants will receive livmoniplimab (dose A) in combination with budigalimab, as part of the approximately 3.5 years study duration.
  • Experimental: Arm 2: Livmoniplimab (Dose B) + Budigalimab
    Participants will receive livmoniplimab (dose B) in combination with budigalimab, as part of the approximately 3.5 years study duration.
  • Experimental: Arm 3: Docetaxel, Paclitaxel, or Gemcitabine
    Participants will receive docetaxel, paclitaxel, or gemcitabine, investigator's choice, as part of the approximately 3.5 years study duration.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to Approximately 3.5 Years ]

Locations (11)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group - Springdale /ID# 270290SpringdaleArkansas72762-
University of California San Francisco - Mission Bay /ID# 270289San FranciscoCalifornia94158-
Yale University School of Medicine /ID# 270449New HavenConnecticut06510-
Medical Oncology Hematology Consultants /ID# 271347NewarkDelaware19713-
Florida Cancer Specialists - North /ID# 271215St. PetersburgFlorida33705-
Icahn School of Medicine at Mount Sinai /ID# 270272New YorkNew York10029-
University Hospitals Cleveland Medical Center /ID# 271010ClevelandOhio44106-
The Ohio State University /ID# 271349ColumbusOhio43210-
SCRI Oncology Partners /ID# 270439NashvilleTennessee37203-
Texas Oncology - Austin Central /ID# 271284AustinTexas78731-
Utah Cancer Specialist /ID# 270810Salt Lake CityUtah84124-

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Highlands Oncology Group - Springdale· Springdale, ARUniversity of California San Francisco - Mission Bay· San Francisco, CAYale University School of Medicine· New Haven, CTMedical Oncology Hematology Consultants· Newark, DEFlorida Cancer Specialists - North· St. Petersburg, FLIcahn School of Medicine at Mount Sinai· New York, NY

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