NCT06632951Active, not recruitingPhase 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, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma
Source: ClinicalTrials.gov · Last updated 11 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 8 Oct 2024
- Start date
- 20 Jan 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- AbbVie
- Diseases
- Bladder cancer
- NCT number
- NCT06632951
- EU CT number
- 2024-515506-11-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 20 Jan 2025 to the primary completion date, Mar 2027
- 45 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has received more than 1 antibody-drug conjugate (ADC) in metastatic setting.
- Has had prior radiation therapy within 28 days prior to first dose of study drug or who has not recovered (i.e., \<= Grade 1 or at baseline) from adverse events due to radiotherapy.
- Prior allogeneic stem cell or solid organ transplantation.
Other illness
- History of additional malignancy or history of prior malignancy, except for adequately treated basal or squamous skin cancer, or cervical carcinoma in situ without evidence of disease, or malignancy treated with curative intent and with no evidence of disease recurrence for 5 years since the initiation of that therapy.
Lab values
- Participant has received more than 1 prior chemotherapy regimen for urothelial cancer in metastatic setting, including chemotherapy agents planned in comparator arm.
- Platinum based chemotherapy administered in adjuvant or neoadjuvant setting will count towards this criterion if participant progressed within 6 months of completion.
- Chemotherapy administered during concurrent chemoradiotherapy for primary cancer will not count towards this criterion.
- The substitution of carboplatin for cisplatin does not constitute a new regimen provided no new chemotherapeutic agents were added to the regimen and no progression was noted prior to the change in platinum.
- Antibody-drug conjugate (ADC) will not count towards this criterion.
- Participant who previously received gemcitabine in combination with platinum in metastatic setting will be eligible to receive docetaxel or paclitaxel in comparator arm.
Who the study is looking for
- Participant has histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Mixed histologic types are allowed if urothelial (transitional cell) is the predominant histology.
- Participant has radiologically documented metastatic disease.
- Participant must have experienced radiographic progression or relapse on checkpoint inhibitor (anti-programmed cell death protein 1 \[PD-1\] or anti-programmed death-ligand 1 \[PD-L1\]) in the metastatic, adjuvant, or neo-adjuvant setting. Participant must have received at least 2 cycles of anti-PD-1 or anti-PD-L1.
- Participants eligible for platinum must have received a platinum containing regimen (cisplatin or carboplatin) in the metastatic, locally advanced, neoadjuvant, or adjuvant setting. If platinum was administered in the neoadjuvant or adjuvant setting, participant must have progressed within 6 months of completion of treatment. Platinum ineligible participants may enroll in this study without receiving a platinum containing regimen.
- Participant has at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by investigator.
- Life expectancy must be at least 3 months.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (45)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635 Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Completed |
| Oncopole Claudius Regaud Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| Rambam Health Care Campus /ID# 270105 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Meir Medical Center /ID# 270108 Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Rabin Medical Center /ID# 270107 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 270096 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center /ID# 270106 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Fukushima Medical University Hospital /ID# 270752 Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Hirosaki University Hospital /ID# 270531 Coordinator of this site? Confirm its status | Hirosaki | Japan | Unknown status |
| Kanazawa University Hospital /ID# 270473 Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| University of Tsukuba Hospital /ID# 270354 Coordinator of this site? Confirm its status | Tsukuba | Japan | Unknown status |
| National Cancer Center /ID# 270453 Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital /ID# 271299 Coordinator of this site? Confirm its status | Hwasun-gun | South Korea | Unknown status |
| Yonsei University Health System Severance Hospital /ID# 270317 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center /ID# 270898 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center /ID# 270318 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Texas Oncology - Austin Central /ID# 271284 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| University Hospitals Cleveland Medical Center /ID# 271010 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Ohio State University /ID# 271349 Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| SCRI Oncology Partners /ID# 270439 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Medical Oncology Hematology Consultants /ID# 271347 Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Yale University School of Medicine /ID# 270449 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai /ID# 270272 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Utah Cancer Specialist /ID# 270810 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of California San Francisco - Mission Bay /ID# 270289 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Highlands Oncology Group - Springdale /ID# 270290 Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
| Florida Cancer Specialists - North /ID# 271215 Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.