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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
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

Full criteria on ClinicalTrials.gov

Sites (45)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Jules Bordet
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AnderlechtBelgiumCompleted
Az Maria Middelares Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital del Mar
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BarcelonaSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
MD Anderson Cancer Center
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MadridSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Centre Leon Berard
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LyonFranceCompleted
Institut Paoli-Calmettes
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MarseilleFranceCompleted
Hospital Foch
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SuresnesFranceCompleted
Oncopole Claudius Regaud
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Toulouse Cedex 9FranceCompleted
Institut Gustave Roussy
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VillejuifFranceCompleted
Rambam Health Care Campus /ID# 270105
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HaifaIsraelUnknown status
Meir Medical Center /ID# 270108
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Kfar SabaIsraelUnknown status
Rabin Medical Center /ID# 270107
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Petah TikvaIsraelUnknown status
The Chaim Sheba Medical Center /ID# 270096
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Ramat GanIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 270106
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Tel AvivIsraelUnknown status
Fukushima Medical University Hospital /ID# 270752
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FukushimaJapanUnknown status
Hirosaki University Hospital /ID# 270531
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HirosakiJapanUnknown status
Kanazawa University Hospital /ID# 270473
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KanazawaJapanUnknown status
University of Tsukuba Hospital /ID# 270354
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TsukubaJapanUnknown status
National Cancer Center /ID# 270453
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Goyang-siSouth KoreaUnknown status
Chonnam National University Hwasun Hospital /ID# 271299
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Hwasun-gunSouth KoreaUnknown status
Yonsei University Health System Severance Hospital /ID# 270317
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SeoulSouth KoreaUnknown status
Asan Medical Center /ID# 270898
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SeoulSouth KoreaUnknown status
Samsung Medical Center /ID# 270318
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SeoulSouth KoreaUnknown status
Aidport sp z o.o.
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SkorzewoPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandCompleted
Texas Oncology - Austin Central /ID# 271284
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AustinUnited StatesUnknown status
University Hospitals Cleveland Medical Center /ID# 271010
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ClevelandUnited StatesUnknown status
The Ohio State University /ID# 271349
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ColumbusUnited StatesUnknown status
SCRI Oncology Partners /ID# 270439
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NashvilleUnited StatesUnknown status
Medical Oncology Hematology Consultants /ID# 271347
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NewarkUnited StatesUnknown status
Yale University School of Medicine /ID# 270449
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New HavenUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai /ID# 270272
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New YorkUnited StatesUnknown status
Utah Cancer Specialist /ID# 270810
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Salt Lake CityUnited StatesUnknown status
University of California San Francisco - Mission Bay /ID# 270289
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San FranciscoUnited StatesUnknown status
Highlands Oncology Group - Springdale /ID# 270290
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SpringdaleUnited StatesUnknown status
Florida Cancer Specialists - North /ID# 271215
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St. PetersburgUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.