Livmoniplimab: Intravenous (IV) Infusion
Budigalimab: IV Infusion
Docetaxel: IV Infusion
Paclitaxel: IV Injection
Docetaxel: IV Injection
Paclitaxel: IV Infusion
Gemcitabine: IV Infusion
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Highlands Oncology Group - Springdale /ID# 270290 | Springdale | Arkansas | |
| University of California San Francisco - Mission Bay /ID# 270289 | San Francisco | California | |
| Yale University School of Medicine /ID# 270449 | New Haven | Connecticut | |
| Medical Oncology Hematology Consultants /ID# 271347 | Newark | Delaware | |
| Florida Cancer Specialists - North /ID# 271215 | St. Petersburg | Florida | |
| Icahn School of Medicine at Mount Sinai /ID# 270272 | New York | New York | |
| University Hospitals Cleveland Medical Center /ID# 271010 | Cleveland | Ohio | |
| The Ohio State University /ID# 271349 | Columbus | Ohio | |
| SCRI Oncology Partners /ID# 270439 | Nashville | Tennessee | |
| Texas Oncology - Austin Central /ID# 271284 | Austin | Texas | |
| Utah Cancer Specialist /ID# 270810 | Salt Lake City | Utah | |
| Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635 | Québec | Quebec | |
| Institut Paoli-Calmettes /ID# 270580 | Marseille | Bouches-du-Rhone | |
| Hôpital Foch /ID# 270573 | Suresnes | Hauts-de-Seine | |
| Institut Gustave Roussy /ID# 270575 | Villejuif | Île-de-France Region | |
| Meir Medical Center /ID# 270108 | Kfar Saba | Central District | |
| The Chaim Sheba Medical Center /ID# 270096 | Ramat Gan | Tel Aviv | |
| Tel Aviv Sourasky Medical Center /ID# 270106 | Tel Aviv | Tel Aviv | |
| Rambam Health Care Campus /ID# 270105 | Haifa | Israel | |
| Rabin Medical Center /ID# 270107 | Petah Tikva | Israel | |
| Hirosaki University Hospital /ID# 270531 | Hirosaki | Aomori | |
| Fukushima Medical University Hospital /ID# 270752 | Fukushima | Fukushima | |
| University of Tsukuba Hospital /ID# 270354 | Tsukuba | Ibaraki | |
| Kanazawa University Hospital /ID# 270473 | Kanazawa | Ishikawa-ken | |
| Aidport Sp. z o.o. /ID# 270049 | Skórzewo | Greater Poland Voivodeship | |
| Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 270046 | Warsaw | Masovian Voivodeship | |
| National Cancer Center /ID# 270453 | Goyang-si | Gyeonggido | |
| Chonnam National University Hwasun Hospital /ID# 271299 | Hwasun-gun | Jeonranamdo | |
| Yonsei University Health System Severance Hospital /ID# 270317 | Seoul | Seoul Teugbyeolsi | |
| Asan Medical Center /ID# 270898 | Seoul | Seoul Teugbyeolsi | |
| Samsung Medical Center /ID# 270318 | Seoul | Seoul Teugbyeolsi | |
| 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06632951 on ClinicalTrials.gov ↗ ← All trials in the USA