Home › Trials › NCT06632951

Evaluating a new treatment for advanced bladder cancer

A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma

PHASE2 · AbbVie · NCT06632951

This study is testing a new combination of two drugs for adults with advanced bladder cancer to see if it works better than standard chemotherapy treatments.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie (industry)
Drugs / interventionschemotherapy, radiation, livmoniplimab, budigalimab
Locations31 sites (Springdale, Arkansas and 30 other locations)
Trial IDNCT06632951 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of livmoniplimab, an investigational drug, when combined with budigalimab in adults with urothelial carcinoma that has progressed after previous treatments. Participants will be randomly assigned to receive either the combination of these two drugs or standard chemotherapy options like docetaxel, paclitaxel, or gemcitabine. The study will enroll approximately 150 participants across 56 sites worldwide, focusing on those with documented metastatic disease who have not responded to prior therapies.

Who should consider this trial

Good fit: Ideal candidates are adults with confirmed metastatic urothelial carcinoma who have experienced disease progression after prior checkpoint inhibitor therapy.

Not a fit: Patients who have not received prior treatment for their urothelial carcinoma or those with non-metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced urothelial carcinoma who have limited treatment choices.

How similar studies have performed: While there have been studies exploring similar combinations in urothelial carcinoma, the specific combination of livmoniplimab and budigalimab is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Springdale, Arkansas and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Docetaxel, Paclitaxel, Gemcitabine, Livmoniplimab, Budigalimab, ABBV-181

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.