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) (NCT06632951)
A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Highlands Oncology Group - Springdale /ID# 270290 — Springdale, Arkansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- 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,
- Rabin Medical Center /ID# 270107 — Petah Tikva,
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Urothelial Carcinoma
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- A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma — Houston, Texas
- A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder — Bloomington, Indiana
- Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma — Oklahoma City, Oklahoma
- Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC — Tampa, Florida
Explore by condition: All Urothelial Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.