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)

Launched by ABBVIE · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination for adults with urothelial carcinoma (UC), a type of cancer that affects the bladder and other parts of the urinary system. Researchers want to see how well two investigational drugs, livmoniplimab and budigalimab, work together and what side effects they might cause. Participants will be randomly assigned to receive either one of the two doses of the new drugs or a standard chemotherapy drug chosen by their doctor. The study aims to enroll about 150 adults and will last for approximately 3.5 years, with regular visits for medical assessments and tests.

To be eligible for this trial, participants must have a confirmed diagnosis of urothelial carcinoma that has spread, and they need to have previously received specific treatments without success. Key criteria include having measurable cancer lesions and a life expectancy of at least three months. Participants should be prepared for more frequent hospital visits compared to standard treatments, as they will undergo regular evaluations and tests throughout the study. This trial offers a potential new option for patients whose cancer has progressed despite previous treatments.

Gender

ALL

Eligibility 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.