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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 Patients With Untreated Inoperable or Metastatic Urothelial Cancer (CheckMate901)

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ClinicalTrials.gov Identifier: NCT03036098
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : August 27, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 patients 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 990 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 : July 26, 2021
Estimated Study Completion Date : December 29, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: Investigational immunotherapy
Specified dose of nivolumab and ipilimumab on specified days followed by nivolumab only on specified days
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
Specified dose of gemcitabine / cisplatin or gemcitabine / carboplatin on specified days
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
Specified dose of nivolumab plus gemcitabine-cisplatin followed by nivolumab only on specified days
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
Specified dose of gemcitabine-cisplatin only on specified days
Drug: gemcitabine
Specified Dose on Specified Days

Drug: cisplatin
Specified Dose on Specified Days




Primary Outcome Measures :
  1. Overall survival (OS) in cisplatin-ineligible randomized participants [ Time Frame: Up to 55 months ]
    Measured by time Only applies to primary study

  2. OS in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) [ Time Frame: Up to 52 months ]
    Only applies to primary study

  3. PFS by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic Urothelial Carcinoma( UC) [ Time Frame: Up to 55 months ]
    Progression Free Survival (PFS) Measured by time Only applies to sub-study


Secondary Outcome Measures :
  1. Overall survival (OS) in all randomized participants [ Time Frame: Up to 55 months ]
    Measured by time Applies to primary study

  2. PFS by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (≥1%) randomized participants and in all randomized participants [ Time Frame: Up to 55 months ]
    Measured by time Applies to primary study

  3. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Global Health Status score in all randomized participants [ Time Frame: Up to 55 months ]
    Measured by EORTC QLQ-C30 Applies to primary study

  4. OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC. [ Time Frame: Up to 55 months ]
    Measured by time Applies to sub-study

  5. European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score [ Time Frame: Up to 55 months ]
    Applies to sub-study

  6. PFS in PD-L1 positive by BICR (using RECIST 1.1) [ Time Frame: Up to 55 months ]
    Applies to sub-study

  7. OS by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC) [ Time Frame: Up to 55 months ]
    Applies to sub-study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 activities such as light house work or office work
  • No prior systemic chemotherapy treatment in the metastatic setting

Exclusion Criteria:

- 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-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol defined inclusion/exclusion criteria could apply


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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 191 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03036098     History of Changes
Other Study ID Numbers: CA209-901
2016-003881-14 ( EudraCT Number )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019

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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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Gemcitabine
Cisplatin
Carboplatin
Nivolumab
Ipilimumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological