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ACTIVE NOT RECRUITING
NCT06632951
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Livmoniplimab

Intravenous (IV) Infusion

DRUG

Budigalimab

IV Infusion

DRUG

Docetaxel

IV Infusion

DRUG

Paclitaxel

IV Injection

DRUG

Docetaxel

IV Injection

DRUG

Paclitaxel

IV Infusion

DRUG

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