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

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 - CheckMate 901: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 901

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003881-14-FI

Enrollment

1375

Registered

2017-05-12

Start date

2017-06-07

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated Unresectable or Metastatic Urothelial Cancer MedDRA version: 20.0 Level: LLT Classification code 10064467 Term: Urothelial carcinoma System Organ Class: 100000004864

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial-CLINICAL Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NIVOLUMAB CAS Nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Metastatic or inoperable urothelial cancer - Must have at least 1 lesion with measurable disease - Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work - No prior systemic chemotherapy treatment in the metastatic setting 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 206 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1169

Exclusion criteria

Exclusion criteria: - Patients with ECOG PS >= 2 - Patients with disease that is suitable for local therapy administered with curative intent - Patients with active brain metastases or leptomeningeal metastases - Patients with active, known or suspected autoimmune disease - 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. - Participants may not have received live/attenuated vaccines within 30 days prior to first study treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: Main study: -To compare Overall Survival (OS) of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic urothelial carcinoma (UC). -To compare OS of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in PD-L1 positive (>= 1%) participants with previously untreated, unresectable or metastatic UC.;Secondary Objective: Main Study: - To compare OS of nivolumab combined with ipilimumab versus SOC chemotherapy in all randomized participants with previously untreated, unresectable or metastatic UC. -To evaluate Progression-Free Survival (PFS) of nivolumab combined with ipilimumab versus SOC chemotherapy in cisplatin-ineligible randomized participants, in PD-L1 positive (>= 1%) randomized participants and in all randomized participants with previously untreated, unresectable or metastatic UC. -To evaluate changes from baseline in Health-Related QOL (HRQoL) of nivolumab combined with ipilimumab versus SOC chemotherapy in allrandomized participants with previously untreated, unresectable or metastatic UC.;Primary end point(s): Main study: -Primary endpoint of OS in cisplatin-ineligible randomized participants -Primary endpoint of OS in PD-L1 positive (>= 1%) randomized participants by immunohistochemistry (IHC) Substudy : PFS by BICR (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC;Timepoint(s) of evaluation of this end point: Up to 55 months from the randomization of the first participant in the study	—

Measure

Time frame

Main Objective: Main study: -To compare Overall Survival (OS) of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic urothelial carcinoma (UC). -To compare OS of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in PD-L1 positive (>= 1%) participants with previously untreated, unresectable or metastatic UC.;Secondary Objective: Main Study: - To compare OS of nivolumab combined with ipilimumab versus SOC chemotherapy in all randomized participants with previously untreated, unresectable or metastatic UC. -To evaluate Progression-Free Survival (PFS) of nivolumab combined with ipilimumab versus SOC chemotherapy in cisplatin-ineligible randomized participants, in PD-L1 positive (>= 1%) randomized participants and in all randomized participants with previously untreated, unresectable or metastatic UC. -To evaluate changes from baseline in Health-Related QOL (HRQoL) of nivolumab combined with ipilimumab versus SOC chemotherapy in allrandomized participants with previously untreated, unresectable or metastatic UC.;Primary end point(s): Main study: -Primary endpoint of OS in cisplatin-ineligible randomized participants -Primary endpoint of OS in PD-L1 positive (>= 1%) randomized participants by immunohistochemistry (IHC) Substudy : PFS by BICR (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC;Timepoint(s) of evaluation of this end point: Up to 55 months from the randomization of the first participant in the study

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Secondary

Measure	Time frame
Secondary end point(s): Main study: - OS in all randomized participants - PFS by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (>=1%) randomized participants and in all randomized participants - European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants Substudy: -OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC -European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score -PFS by BICR (using RECIST 1.1) and OS by PD-L1 expression at = 1% expression by immunohistochemistry (IHC);Timepoint(s) of evaluation of this end point: Up to 55 months from the randomization of the first participant in the study	—

Measure

Time frame

Secondary end point(s): Main study: - OS in all randomized participants - PFS by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (>=1%) randomized participants and in all randomized participants - European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants Substudy: -OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC -European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score -PFS by BICR (using RECIST 1.1) and OS by PD-L1 expression at = 1% expression by immunohistochemistry (IHC);Timepoint(s) of evaluation of this end point: Up to 55 months from the randomization of the first participant in the study

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Countries

Argentina, Australia, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Norway, Peru, Poland, Romania, South Africa, Spain, Sweden, Switzerland, Taiwan, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026