Evaluating a new treatment for advanced bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Highlands Oncology Group - Springdale /ID# 270290
  Springdale, Arkansas, United States Recruiting
• University of California San Francisco - Mission Bay /ID# 270289
  San Francisco, California, United States Recruiting
• Medical Oncology Hematology Consultants /ID# 271347
  Newark, Delaware, United States Recruiting
• Florida Cancer Specialists - North /ID# 271215
  Saint Petersburg, Florida, United States Recruiting
• Icahn School of Medicine at Mount Sinai /ID# 270272
  New York, New York, United States Recruiting
• The Ohio State University /ID# 271349
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Trastuzumab plus serplulimab with chemotherapy for HER2-positive advanced biliary tract or urothelial cancer after prior therapy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.