Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
In this trial, participants will be randomized into four arms. In the first arm (Arm A), participants will receive a specified dose of nivolumab and ipilimumab on specified days. In the second arm (Arm B), participants will receive a specified dose of gemcitabine / cisplatin or gemcitabine / carboplatin chemotherapy on specified days. In the third arm (Arm C), participants will receive a specified dose of nivolumab, plus gemcitabine-cisplatin chemotherapy, followed by nivolumab on specified days. In the final arm (Arm D), participants will receive a specified dose of gemcitabine-cisplatin chemotherapy only on specified days.
Conditions
This trial is treating people with Urothelial Cancer
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bristol-Myers Squibb (BMS)
Scientific Title
A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
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