Study on the Safety and Effects of Livmoniplimab and Budigalimab for Treating Urothelial Carcinoma

Sponsor: AbbVie

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06632951

Provider View

This clinical trial is testing a new combination of drugs, livmoniplimab and budigalimab, to see if they are safe and effective in treating adults with urothelial carcinoma, a type of bladder cancer, that has returned or worsened after initial treatment.

Patient Parameters

Program Overview

Urothelial carcinoma is a common type of bladder cancer. While treatments have improved, there is still a need for better options for patients whose cancer has come back or progressed after initial treatment. This study is testing a new combination of drugs, livmoniplimab and budigalimab, to find the best dose and to see if they can help control the cancer. Participants will be randomly assigned to one of three groups: two groups will receive different doses of livmoniplimab with budigalimab, and the third group will receive standard chemotherapy drugs chosen by the doctor. The study will last about 3.5 years and will involve regular hospital or clinic visits for tests and assessments.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of urothelial carcinoma, which is cancer of the bladder, renal pelvis, ureter, or urethra.
  • Have cancer that has spread to other parts of the body, as shown by scans.
  • Have had cancer that got worse or came back after treatment with certain immune therapies (anti-PD-1 or anti-PD-L1) and have received at least two cycles of these treatments.
  • If eligible for platinum-based chemotherapy, must have received it in the past, unless not suitable for such treatment.
  • Have at least one tumor that can be measured by scans.
  • Have a life expectancy of at least 3 months.

Exclusion Criteria

  • Have received more than one previous chemotherapy treatment for urothelial cancer in the metastatic setting.
  • Have had more than one antibody-drug conjugate treatment in the metastatic setting.
  • Have had radiation therapy within 28 days before starting the study treatment or have not recovered from side effects of previous radiation.
  • Have a history of other cancers, except for certain skin cancers or cervical cancer that have been treated and have not returned for at least 5 years.
  • Have had a stem cell or organ transplant in the past.

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