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-NL

Enrollment

1792

Registered

2017-03-14

Start date

2017-04-18

Completion date

Unknown

Last updated

2024-07-08

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: -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

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

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 all randomized participants with previously untreated, unresectable or metastatic UC.;Primary end point(s): Main study: - Overall survival (OS) in cisplatin-ineligible randomized participants - Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) Sub-study : - Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC - Overall survival (OS) 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 (for the main study), up to 64 months for the sub-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 all randomized participants with previously untreated, unresectable or metastatic UC.;Primary end point(s): Main study: - Overall survival (OS) in cisplatin-ineligible randomized participants - Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) Sub-study : - Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC - Overall survival (OS) 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 (for the main study), up to 64 months for the sub-study

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Secondary

Measure	Time frame
Secondary end point(s): Main study: - Overall survival (OS) in all randomized participants - Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants - Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PDL1 positive (=1%) randomized participants - Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants - European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants Sub-study: - European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC - Progression-free survival (PFS) by BICR (using RECIST 1.1) by immunohistochemistry (IHC) - Overall survival (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 (for the main study), up to 64 months for the sub-study	—

Measure

Time frame

Secondary end point(s): Main study: - Overall survival (OS) in all randomized participants - Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants - Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PDL1 positive (=1%) randomized participants - Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants - European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants Sub-study: - European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC - Progression-free survival (PFS) by BICR (using RECIST 1.1) by immunohistochemistry (IHC) - Overall survival (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 (for the main study), up to 64 months for the sub-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 ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

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