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)

Study Identifier
M25-204
CT.gov Identifier
NCT06632951
EudraCT Identifier
Not available
EUCTIS ID
2024-515506-11-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Genitourinary Cancer - Urothetial Cancer
    • Study Drug
  • Livmoniplimab
  • Budigalimab
  • Docetaxel
  • Paclitaxel
  • Gemcitabine
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Highlands Oncology Group - Springdale /ID# 270290
    Springdale, Arkansas, United States, 72762
    Status
    Not applicable
    Location
    University of California San Francisco - Mission Bay /ID# 270289
    San Francisco, California, United States, 94158
    Status
    Not applicable
    Location
    Yale University School of Medicine /ID# 270449
    New Haven, Connecticut, United States, 06510
    Status
    Not applicable
    Location
    Medical Oncology Hematology Consultants /ID# 271347
    Newark, Delaware, United States, 19713
    Status
    Not applicable
    Location
    Florida Cancer Specialists - North /ID# 271215
    St. Petersburg, Florida, United States, 33705
    Status
    Not applicable
    Location
    Icahn School of Medicine at Mount Sinai /ID# 270272
    New York, New York, United States, 10029
    Status
    Not applicable
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