Study of Nivolumab in Combination With Ipilimumab or with Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy in Treatment of Patients with Untreated Inoperable or Metastatic Urothelial Cancer

Phase 1

• Conditions: ntreated Unresectable or Metastatic Urothelial Cancer; MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003881-14-NL
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-14
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1792

Inclusion Criteria

-Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra
-No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC)
-Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
-Women and men must agree to follow specific methods of contraception, if applicable
Other protocol-defined inclusion criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 269
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1523

Exclusion Criteria

-Disease that is suitable for local therapy administered with curative intent
-Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results
-Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
Other protocol-defined exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified