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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)
Sponsor: AbbVie
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.
Official title: A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-01-20
Completion Date
2028-08
Last Updated
2025-08-11
Healthy Volunteers
No
Conditions
Interventions
Livmoniplimab
Intravenous (IV) Infusion
Budigalimab
IV Infusion
Docetaxel
IV Infusion
Paclitaxel
IV Injection
Docetaxel
IV Injection
Paclitaxel
IV Infusion
Gemcitabine
IV Infusion
Locations (37)
Highlands Oncology Group - Springdale /ID# 270290
Springdale, Arkansas, United States
University of California San Francisco - Mission Bay /ID# 270289
San Francisco, California, United States
Yale University School of Medicine /ID# 270449
New Haven, Connecticut, United States
Medical Oncology Hematology Consultants /ID# 271347
Newark, Delaware, United States
Florida Cancer Specialists - North /ID# 271215
St. Petersburg, Florida, United States
Icahn School of Medicine at Mount Sinai /ID# 270272
New York, New York, United States
University Hospitals Cleveland Medical Center /ID# 271010
Cleveland, Ohio, United States
The Ohio State University /ID# 271349
Columbus, Ohio, United States
SCRI Oncology Partners /ID# 270439
Nashville, Tennessee, United States
Texas Oncology - Austin Central /ID# 271284
Austin, Texas, United States
Utah Cancer Specialist /ID# 270810
Salt Lake City, Utah, United States
Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635
Québec, Quebec, Canada
Institut Paoli-Calmettes /ID# 270580
Marseille, Bouches-du-Rhone, France
Hôpital Foch /ID# 270573
Suresnes, Hauts-de-Seine, France
Institut Gustave Roussy /ID# 270575
Villejuif, Île-de-France Region, France
Meir Medical Center /ID# 270108
Kfar Saba, Central District, Israel
The Chaim Sheba Medical Center /ID# 270096
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 270106
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 270105
Haifa, Israel
Rabin Medical Center /ID# 270107
Petah Tikva, Israel
Hirosaki University Hospital /ID# 270531
Hirosaki, Aomori, Japan
Fukushima Medical University Hospital /ID# 270752
Fukushima, Fukushima, Japan
University of Tsukuba Hospital /ID# 270354
Tsukuba, Ibaraki, Japan
Kanazawa University Hospital /ID# 270473
Kanazawa, Ishikawa-ken, Japan
Aidport Sp. z o.o. /ID# 270049
Skórzewo, Greater Poland Voivodeship, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 270046
Warsaw, Masovian Voivodeship, Poland
National Cancer Center /ID# 270453
Goyang-si, Gyeonggido, South Korea
Chonnam National University Hwasun Hospital /ID# 271299
Hwasun-gun, Jeonranamdo, South Korea
Yonsei University Health System Severance Hospital /ID# 270317
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 270898
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 270318
Seoul, Seoul Teugbyeolsi, South Korea
Parc de Salut Mar - Hospital del Mar /ID# 270173
Barcelona, Spain
Hospital Universitario Vall d'Hebron /ID# 269783
Barcelona, Spain
Hospital Clinic de Barcelona /ID# 269789
Barcelona, Spain
Hospital MD Anderson Cancer Center Madrid /ID# 269780
Madrid, Spain
Hospital Clinico San Carlos /ID# 269786
Madrid, Spain
Hospital Universitario Virgen del Rocio /ID# 269782
Seville, Spain