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Clinical Trials in the USA / NCT06632951
Active, not recruiting Phase 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)

NCT06632951 · tracked via the Priya Life Science USA tracker
Sponsor
AbbVie
Phase
Phase 2
Started
2025-01-20
Last updated
2025-08-11

Condition(s) studied

Urothelial Carcinoma

Investigational drug(s) / intervention(s)

Livmoniplimab →Budigalimab →Docetaxel →Paclitaxel →Docetaxel →Paclitaxel →Gemcitabine →

Livmoniplimab: Intravenous (IV) Infusion

Budigalimab: IV Infusion

Docetaxel: IV Infusion

Paclitaxel: IV Injection

Docetaxel: IV Injection

Paclitaxel: IV Infusion

Gemcitabine: IV Infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
Highlands Oncology Group - Springdale /ID# 270290 Springdale Arkansas
University of California San Francisco - Mission Bay /ID# 270289 San Francisco California
Yale University School of Medicine /ID# 270449 New Haven Connecticut
Medical Oncology Hematology Consultants /ID# 271347 Newark Delaware
Florida Cancer Specialists - North /ID# 271215 St. Petersburg Florida
Icahn School of Medicine at Mount Sinai /ID# 270272 New York New York
University Hospitals Cleveland Medical Center /ID# 271010 Cleveland Ohio
The Ohio State University /ID# 271349 Columbus Ohio
SCRI Oncology Partners /ID# 270439 Nashville Tennessee
Texas Oncology - Austin Central /ID# 271284 Austin Texas
Utah Cancer Specialist /ID# 270810 Salt Lake City Utah
Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635 Québec Quebec
Institut Paoli-Calmettes /ID# 270580 Marseille Bouches-du-Rhone
Hôpital Foch /ID# 270573 Suresnes Hauts-de-Seine
Institut Gustave Roussy /ID# 270575 Villejuif Île-de-France Region
Meir Medical Center /ID# 270108 Kfar Saba Central District
The Chaim Sheba Medical Center /ID# 270096 Ramat Gan Tel Aviv
Tel Aviv Sourasky Medical Center /ID# 270106 Tel Aviv Tel Aviv
Rambam Health Care Campus /ID# 270105 Haifa Israel
Rabin Medical Center /ID# 270107 Petah Tikva Israel
Hirosaki University Hospital /ID# 270531 Hirosaki Aomori
Fukushima Medical University Hospital /ID# 270752 Fukushima Fukushima
University of Tsukuba Hospital /ID# 270354 Tsukuba Ibaraki
Kanazawa University Hospital /ID# 270473 Kanazawa Ishikawa-ken
Aidport Sp. z o.o. /ID# 270049 Skórzewo Greater Poland Voivodeship
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 270046 Warsaw Masovian Voivodeship
National Cancer Center /ID# 270453 Goyang-si Gyeonggido
Chonnam National University Hwasun Hospital /ID# 271299 Hwasun-gun Jeonranamdo
Yonsei University Health System Severance Hospital /ID# 270317 Seoul Seoul Teugbyeolsi
Asan Medical Center /ID# 270898 Seoul Seoul Teugbyeolsi
Samsung Medical Center /ID# 270318 Seoul Seoul Teugbyeolsi
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06632951 on ClinicalTrials.gov ↗ ← All trials in the USA