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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urothelial Carcinoma
• Intervention / Treatment: Drug: Docetaxel; Drug: Budigalimab; Drug: Livmoniplimab; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Docetaxel; Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1J 1Z4
      • Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635
• France
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13273
      • Institut Paoli-Calmettes /ID# 270580
  • Hauts-de-Seine
    • Suresnes CEDEX, Hauts-de-Seine, France, 92151
      • Hôpital Foch /ID# 270573
  • Ile-de-France
    • Villejuif, Ile-de-France, France, 94800
      • Institut Gustave Roussy /ID# 270575
• Israel
  • Haifa, Israel, 3525408
    • Rambam Health Care Campus /ID# 270105
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 270107
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 4428164
      • Meir Medical Center /ID# 270108
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 270096
    • Tel Aviv, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 270106
• Japan
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
      • Hirosaki University Hospital /ID# 270531
  • Fukushima
    • Fukushima-shi, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 270752
  • Ibaraki
    • Tsukuba-shi, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital /ID# 270354
  • Ishikawa
    • Kanazawa City, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital /ID# 270473
• Korea, Republic of
  • Gyeonggido
    • Goyang-si, Gyeonggido, Korea, Republic of, 10408
      • National Cancer Center /ID# 270453
  • Jeonranamdo
    • Hwasun-gun, Jeonranamdo, Korea, Republic of, 58128
      • Chonnam National University Hwasun Hospital /ID# 271299
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Yonsei University Health System Severance Hospital /ID# 270317
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
      • Asan Medical Center /ID# 270898
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center /ID# 270318
• Poland
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-781
      • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 270046
  • Wielkopolskie
    • Skorzewo, Wielkopolskie, Poland, 60-185
      • Aidport Sp. z o.o. /ID# 270049
• Spain
  • Barcelona, Spain, 08003
    • Parc de Salut Mar - Hospital del Mar /ID# 270173
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 269783
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 269789
  • Madrid, Spain, 28033
    • Hospital MD Anderson Cancer Center Madrid /ID# 269780
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos /ID# 269786
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 269782
• United States
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group - Springdale /ID# 270290
  • California
    • San Francisco, California, United States, 94158
      • University of California San Francisco - Mission Bay /ID# 270289
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine /ID# 270449
  • Delaware
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants /ID# 271347
  • Florida
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists - North /ID# 271215
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai /ID# 270272
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center /ID# 271010
    • Columbus, Ohio, United States, 43210
      • The Ohio State University /ID# 271349
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • SCRI Oncology Partners /ID# 270439
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology - Austin Central /ID# 271284
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Utah Cancer Specialist /ID# 270810

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Livmoniplimab (Dose A) + Budigalimab; Participants will receive livmoniplimab (dose A) in combination with budigalimab, as part of the approximately 3.5 years study duration.	Drug: Budigalimab; IV Infusion; Other Names: ABBV-181; Drug: Livmoniplimab; Intravenous (IV) Infusion; Other Names: ABBV-151
Experimental: Arm 2: Livmoniplimab (Dose B) + Budigalimab; Participants will receive livmoniplimab (dose B) in combination with budigalimab, as part of the approximately 3.5 years study duration.	Drug: Budigalimab; IV Infusion; Other Names: ABBV-181; Drug: Livmoniplimab; Intravenous (IV) Infusion; Other Names: ABBV-151
Experimental: Arm 3: Docetaxel, Paclitaxel, or Gemcitabine; Participants will receive docetaxel, paclitaxel, or gemcitabine, investigator's choice, as part of the approximately 3.5 years study duration.	Drug: Docetaxel; IV Infusion; Drug: Gemcitabine; IV Infusion; Drug: Paclitaxel; IV Injection; Drug: Docetaxel; IV Injection; Drug: Paclitaxel; IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time measured from randomization until death from any cause.	Up to Approximately 3.5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free survival (PFS)	PFS is defined as the time measured from randomization until the first documentation of progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by investigators or death from any cause, whichever occurs first.	Up to Approximately 3.5 Years
Best Overall Response (BOR) per Investigator	BOR is defined as achieving complete response (CR) or partial response (PR) according to RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.	Up to Approximately 3.5 Years
Duration of Response (DOR) per Investigator	DOR id defined as the time from first CR/PR until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.	Up to Approximately 3.5 Years
Percentage of Participants with Adverse Events (AE)s	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Approximately 3.5 Years
Percentage of Participants with Serious Adverse Events (SAE)s	An SAE is defined as an AE that results in the death of the participant, threat to the participant's life, hospitalization, congenital abnormality, persistent or significant disability/incapacitation, or medical event requiring medical or surgical interventions to prevent a serious outcome.	Up to Approximately 3.5 Years
Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s	The treatment-emergent period is defined as time from the date of the first dose of study drug up to 90 days after the date of the last dose of study drug, or the first date starting new anticancer therapy, whichever occurs earlier. TEAEs include all AEs that occurred or worsened during the treatment emergent period and all treatment related SAEs as assessed by investigators.	Up to Approximately 3.5 Years
Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator	Vital signs are defined as systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.	Up to Approximately 3.5 Years
Percentage of Participants with Clinically Significant Laboratory Values	Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.	Up to Approximately 3.5 Years
Percentage of Participants with Immune-Related Reactions as AEs of Special Interest	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Approximately 3.5 Years
Maximum Observed Serum Concentration (Cmax) of Livmoniplimab	Cmax is defined as the maximum observed serum concentration of livmoniplimab.	Up to Approximately 3.5 Years
Cmax of Budigalimab	Cmax is defined as the maximum observed serum concentration of budigalimab.	Up to Approximately 3.5 Years
Time to Reach Cmax (Tmax) of Livmoniplimab	Tmax is defined as the time to reach Cmax of livmoniplimab.	Up to Approximately 3.5 Years
Tmax of Budigalimab	Tmax is defined as the time to reach Cmax of budigalimab.	Up to Approximately 3.5 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab	AUC is defined as the area under the serum concentration versus time curve of livmoniplimab.	Up to Approximately 3.5 Years
AUC of Budigalimab	AUC is defined as the area under the serum concentration versus time curve of budigalimab.	Up to Approximately 3.5 Years
Clearance (CL) of Livmoniplimab	CL is defined as the Clearance of livmoniplimab.	Up to Approximately 3.5 Years
CL of Budigalimab	CL is defined as the Clearance of budigalimab.	Up to Approximately 3.5 Years
Volume of Distribution (Vd) of Livmoniplimab	Vd is defined as the volume of distribution of livmoniplimab.	Up to Approximately 3.5 Years
Vd of Budigalimab	Vd is defined as the volume of distribution of budigalimab.	Up to Approximately 3.5 Years
Incidence of Anti-Drug Antibodies (ADAs) of Livmoniplimab	Incidence of anti-drug antibodies of livmoniplimab.	Up to Approximately 3.5 Years
ADAs of Budigalimab	Incidence of anti-drug antibodies of budigalimab.	Up to Approximately 3.5 Years
Incidences of Neutralizing Anti-Drug Antibodies (nADAs) of Livmoniplimab	Incidences of neutralizing anti-drug antibodies of livmoniplimab.	Up to Approximately 3.5 Years
Incidences of nADAs of Budigalimab	Incidences of neutralizing anti-drug antibodies of budigalimab.	Up to Approximately 3.5 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Gemcitabine; Docetaxel; Cancer; Urothelial Carcinoma; Paclitaxel; ABBV-181; Budigalimab; Metastatic Urothelial Carcinoma; Livmoniplimab; ABBV-151; LIVIGNO-3
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Docetaxel; Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel
• Other Study ID Numbers: M25-204; 2024-515506-11-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No