Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer (CheckMate901)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Urothelial Cancer

Treatments: Drug: Gemcitabine; Biological: Nivolumab; Drug: Cisplatin; Biological: Ipilimumab; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03036098

2016-003881-14 (EudraCT Number)

CA209-901

Details and patient eligibility

About

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

Enrollment: 1,322 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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 co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,322 participants in 4 patient groups

Arm A: Investigational immunotherapy

Experimental group

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Arm B: Standard of care chemotherapy

Active Comparator group

Treatment:

Drug: Carboplatin

Drug: Cisplatin

Drug: Gemcitabine

Arm C: Investigational immunotherapy

Experimental group

Treatment:

Drug: Cisplatin

Biological: Nivolumab

Drug: Gemcitabine

Arm D: Standard of care chemotherapy

Active Comparator group

Treatment:

Drug: Cisplatin

Drug: Gemcitabine