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)
LIVIGNO-3
A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma
2 other identifiers
interventional
150
8 countries
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2025
Typical duration for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2024
CompletedFirst Posted
Study publicly available on registry
October 9, 2024
CompletedStudy Start
First participant enrolled
January 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
August 11, 2025
August 1, 2025
2.1 years
October 8, 2024
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as the time measured from randomization until death from any cause.
Up to Approximately 3.5 Years
Secondary Outcomes (23)
Progression-Free survival (PFS)
Up to Approximately 3.5 Years
Best Overall Response (BOR) per Investigator
Up to Approximately 3.5 Years
Duration of Response (DOR) per Investigator
Up to Approximately 3.5 Years
Percentage of Participants with Adverse Events (AE)s
Up to Approximately 3.5 Years
Percentage of Participants with Serious Adverse Events (SAE)s
Up to Approximately 3.5 Years
- +18 more secondary outcomes
Study Arms (3)
Arm 1: Livmoniplimab (Dose A) + Budigalimab
EXPERIMENTALParticipants will receive livmoniplimab (dose A) in combination with budigalimab, as part of the approximately 3.5 years study duration.
Arm 2: Livmoniplimab (Dose B) + Budigalimab
EXPERIMENTALParticipants will receive livmoniplimab (dose B) in combination with budigalimab, as part of the approximately 3.5 years study duration.
Arm 3: Docetaxel, Paclitaxel, or Gemcitabine
EXPERIMENTALParticipants will receive docetaxel, paclitaxel, or gemcitabine, investigator's choice, as part of the approximately 3.5 years study duration.
Interventions
Intravenous (IV) Infusion
IV Infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- 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.
- Prior allogeneic stem cell or solid organ transplantation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (37)
Highlands Oncology Group - Springdale /ID# 270290
Springdale, Arkansas, 72762, United States
University of California San Francisco - Mission Bay /ID# 270289
San Francisco, California, 94158, United States
Yale University School of Medicine /ID# 270449
New Haven, Connecticut, 06510, United States
Medical Oncology Hematology Consultants /ID# 271347
Newark, Delaware, 19713, United States
Florida Cancer Specialists - North /ID# 271215
St. Petersburg, Florida, 33705, United States
Icahn School of Medicine at Mount Sinai /ID# 270272
New York, New York, 10029, United States
University Hospitals Cleveland Medical Center /ID# 271010
Cleveland, Ohio, 44106, United States
The Ohio State University /ID# 271349
Columbus, Ohio, 43210, United States
SCRI Oncology Partners /ID# 270439
Nashville, Tennessee, 37203, United States
Texas Oncology - Austin Central /ID# 271284
Austin, Texas, 78731, United States
Utah Cancer Specialist /ID# 270810
Salt Lake City, Utah, 84124, United States
Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635
Québec, Quebec, G1J 1Z4, Canada
Institut Paoli-Calmettes /ID# 270580
Marseille, Bouches-du-Rhone, 13273, France
Hôpital Foch /ID# 270573
Suresnes, Hauts-de-Seine, 92151, France
Institut Gustave Roussy /ID# 270575
Villejuif, Île-de-France Region, 94800, France
Meir Medical Center /ID# 270108
Kfar Saba, Central District, 4428164, Israel
The Chaim Sheba Medical Center /ID# 270096
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 270106
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus /ID# 270105
Haifa, 3525408, Israel
Rabin Medical Center /ID# 270107
Petah Tikva, 4941492, Israel
Hirosaki University Hospital /ID# 270531
Hirosaki, Aomori, 036-8563, Japan
Fukushima Medical University Hospital /ID# 270752
Fukushima, Fukushima, 960-1295, Japan
University of Tsukuba Hospital /ID# 270354
Tsukuba, Ibaraki, 305-8576, Japan
Kanazawa University Hospital /ID# 270473
Kanazawa, Ishikawa-ken, 920-8641, Japan
Aidport Sp. z o.o. /ID# 270049
Skórzewo, Greater Poland Voivodeship, 60-185, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 270046
Warsaw, Masovian Voivodeship, 02-781, Poland
National Cancer Center /ID# 270453
Goyang-si, Gyeonggido, 10408, South Korea
Chonnam National University Hwasun Hospital /ID# 271299
Hwasun-gun, Jeonranamdo, 58128, South Korea
Yonsei University Health System Severance Hospital /ID# 270317
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Asan Medical Center /ID# 270898
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 270318
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Parc de Salut Mar - Hospital del Mar /ID# 270173
Barcelona, 08003, Spain
Hospital Universitario Vall d'Hebron /ID# 269783
Barcelona, 08035, Spain
Hospital Clinic de Barcelona /ID# 269789
Barcelona, 08036, Spain
Hospital MD Anderson Cancer Center Madrid /ID# 269780
Madrid, 28033, Spain
Hospital Clinico San Carlos /ID# 269786
Madrid, 28040, Spain
Hospital Universitario Virgen del Rocio /ID# 269782
Seville, 41013, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2024
First Posted
October 9, 2024
Study Start
January 20, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
August 1, 2028
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.