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NCT06632951 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Urothelial Carcinoma, sponsored by AbbVie.
- Active
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT06632951: Active Phase 2 study of Urothelial Carcinoma, sponsored by AbbVie.
NCT06632951 is a Phase 2 study of Urothelial Carcinoma that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 150 participants, below the 237-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06632951, a Phase 2 study of Urothelial Carcinoma, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
OS is defined as the time measured from randomization until death from any cause.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Budigalimab
- DRUG Paclitaxel
- DRUG Livmoniplimab
Study Locations (20)
Ohio
- University Hospitals Cleveland Medical Center /ID# 271010 - Cleveland
- The Ohio State University /ID# 271349 - Columbus
Tel Aviv
- The Chaim Sheba Medical Center /ID# 270096 - Ramat Gan
- Tel Aviv Sourasky Medical Center /ID# 270106 - Tel Aviv
Other
- Rambam Health Care Campus /ID# 270105 - Haifa
- Rabin Medical Center /ID# 270107 - Petah Tikva
Arkansas
- Highlands Oncology Group - Springdale /ID# 270290 - Springdale
California
- University of California San Francisco - Mission Bay /ID# 270289 - San Francisco
Connecticut
- Yale University School of Medicine /ID# 270449 - New Haven
Delaware
- Medical Oncology Hematology Consultants /ID# 271347 - Newark
Florida
- Florida Cancer Specialists - North /ID# 271215 - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-01-20 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What the registry record for NCT06632951 still lists
NCT06632951 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 237-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.
NCT06632951 names 20 study sites across 17 states, led by Ohio, Tel Aviv, Other.
Frequently Asked Questions
What is clinical trial NCT06632951 about?
NCT06632951 is a clinical study titled "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)". 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 fr...
What is the current status of trial NCT06632951?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-01-20. Estimated completion is 2028-08.
What conditions does trial NCT06632951 study?
This clinical trial studies the following conditions: Urothelial Carcinoma.
What interventions are being tested in trial NCT06632951?
The interventions under investigation include: Docetaxel (DRUG), Budigalimab (DRUG), Paclitaxel (DRUG), Livmoniplimab (DRUG).
Who is sponsoring clinical trial NCT06632951?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06632951 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06632951's enrollment target sits among peer trials
150 29th of 85 higher than 55 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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