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)

NCT ID: NCT06632951

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2028-08-31

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.

Conditions

Urothelial Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Livmoniplimab

Intervention Type: DRUG

Intravenous (IV) Infusion

Budigalimab

Intervention Type: DRUG

IV Infusion

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.

Group Type: EXPERIMENTAL

Livmoniplimab

Intervention Type: DRUG

Intravenous (IV) Infusion

Budigalimab

Intervention Type: DRUG

IV Infusion

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.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

IV Infusion

Paclitaxel

Intervention Type: DRUG

IV Injection

Docetaxel

Intervention Type: DRUG

IV Injection

Paclitaxel

Intervention Type: DRUG

IV Infusion

Gemcitabine

Intervention Type: DRUG

IV Infusion

Interventions

Livmoniplimab

Intravenous (IV) Infusion

Intervention Type: DRUG

Budigalimab

IV Infusion

Intervention Type: DRUG

Docetaxel

IV Infusion

Intervention Type: DRUG

Paclitaxel

IV Injection

Intervention Type: DRUG

Docetaxel

IV Injection

Intervention Type: DRUG

Paclitaxel

IV Infusion

Intervention Type: DRUG

Gemcitabine

IV Infusion

Intervention Type: DRUG

Other Intervention Names

ABBV-151; ABBV-181

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Highlands Oncology Group - Springdale /ID# 270290

Springdale, Arkansas, United States

University of California San Francisco - Mission Bay /ID# 270289

San Francisco, California, United States

Yale University School of Medicine /ID# 270449

New Haven, Connecticut, United States

Medical Oncology Hematology Consultants /ID# 271347

Newark, Delaware, United States

Florida Cancer Specialists - North /ID# 271215

St. Petersburg, Florida, United States

Icahn School of Medicine at Mount Sinai /ID# 270272

New York, New York, United States

University Hospitals Cleveland Medical Center /ID# 271010

Cleveland, Ohio, United States

The Ohio State University /ID# 271349

Columbus, Ohio, United States

SCRI Oncology Partners /ID# 270439

Nashville, Tennessee, United States

Texas Oncology - Austin Central /ID# 271284

Austin, Texas, United States

Utah Cancer Specialist /ID# 270810

Salt Lake City, Utah, United States

Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635

Québec, Quebec, Canada

Institut Paoli-Calmettes /ID# 270580

Marseille, Bouches-du-Rhone, France

Hôpital Foch /ID# 270573

Suresnes, Hauts-de-Seine, France

Institut Gustave Roussy /ID# 270575

Villejuif, Île-de-France Region, France

Meir Medical Center /ID# 270108

Kfar Saba, Central District, Israel

The Chaim Sheba Medical Center /ID# 270096

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 270106

Tel Aviv, Tel Aviv, Israel

Rambam Health Care Campus /ID# 270105

Haifa, , Israel

Rabin Medical Center /ID# 270107

Petah Tikva, , Israel

Hirosaki University Hospital /ID# 270531

Hirosaki, Aomori, Japan

Fukushima Medical University Hospital /ID# 270752

Fukushima, Fukushima, Japan

University of Tsukuba Hospital /ID# 270354

Tsukuba, Ibaraki, Japan

Kanazawa University Hospital /ID# 270473

Kanazawa, Ishikawa-ken, Japan

Aidport Sp. z o.o. /ID# 270049

Skórzewo, Greater Poland Voivodeship, Poland

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 270046

Warsaw, Masovian Voivodeship, Poland

National Cancer Center /ID# 270453

Goyang-si, Gyeonggido, South Korea

Chonnam National University Hwasun Hospital /ID# 271299

Hwasun-gun, Jeonranamdo, South Korea

Yonsei University Health System Severance Hospital /ID# 270317

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center /ID# 270898

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 270318

Seoul, Seoul Teugbyeolsi, South Korea

Parc de Salut Mar - Hospital del Mar /ID# 270173

Barcelona, , Spain

Hospital Universitario Vall d'Hebron /ID# 269783

Barcelona, , Spain

Hospital Clinic de Barcelona /ID# 269789

Barcelona, , Spain

Hospital MD Anderson Cancer Center Madrid /ID# 269780

Madrid, , Spain

Hospital Clinico San Carlos /ID# 269786

Madrid, , Spain

Hospital Universitario Virgen del Rocio /ID# 269782

Seville, , Spain

Countries

United States; Canada; France; Israel; Japan; Poland; South Korea; Spain

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M25-204

Related Info

Other Identifiers

2024-515506-11-00

Identifier Type: OTHER

Identifier Source: secondary_id

M25-204

Identifier Type: -

Identifier Source: org_study_id