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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03036098
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : June 9, 2023
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urothelial Cancer Biological: Nivolumab Biological: Ipilimumab Drug: Gemcitabine Drug: Cisplatin Drug: Carboplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : July 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Investigational immunotherapy Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Specified Dose on Specified Days
Other Names:
  • BMS-734016
  • Yervoy
Active Comparator: Arm B: Standard of care chemotherapy Drug: Gemcitabine
Specified Dose on Specified Days

Drug: Cisplatin
Specified Dose on Specified Days

Drug: Carboplatin
Specified Dose on Specified Days
Experimental: Arm C: Investigational immunotherapy Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
  • Opdivo

Drug: Gemcitabine
Specified Dose on Specified Days

Drug: Cisplatin
Specified Dose on Specified Days
Active Comparator: Arm D: Standard of care chemotherapy Drug: Gemcitabine
Specified Dose on Specified Days

Drug: Cisplatin
Specified Dose on Specified Days


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) in cisplatin-ineligible randomized participants [ Time Frame: Up to 55 months ]
  2. Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) [ Time Frame: Up to 52 months ]
  3. 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 [ Time Frame: Up to 64 months ]
  4. Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC [ Time Frame: Up to 64 months ]

Secondary Outcome Measures :
  1. Overall survival (OS) in all randomized participants [ Time Frame: Up to 55 months ]
  2. 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 [ Time Frame: Up to 55 months ]
  3. Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PD-L1 positive (≥1%) randomized participants [ Time Frame: Up to 55 months ]
  4. Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants [ Time Frame: Up to 55 months ]
  5. European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants [ Time Frame: Up to 55 months ]
  6. 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 [ Time Frame: Up to 64 months ]
  7. Progression-free survival (PFS) by BICR (using RECIST 1.1) by immunohistochemistry (IHC) [ Time Frame: Up to 64 months ]
  8. Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC) [ Time Frame: Up to 64 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036098


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03036098    
Other Study ID Numbers: CA209-901
2016-003881-14 ( EudraCT Number )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: June 9, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carboplatin
Gemcitabine
Nivolumab
Ipilimumab
Antineoplastic Agents
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors