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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

NCT03036098

Description:

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.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-901
  • SECONDARY ID: 2016-003881-14
  • NCT ID: NCT03036098

Conditions

  • Urothelial Cancer

Interventions

DrugSynonymsArms
nivolumabBMS-936558, OpdivoArm A: Investigational immunotherapy
ipilimumabBMS-734016, YervoyArm A: Investigational immunotherapy
gemcitabineArm B: Standard of care chemotherapy
cisplatinArm B: Standard of care chemotherapy
carboplatinArm B: Standard of care chemotherapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm A: Investigational immunotherapyExperimentalSpecified dose of nivolumab and ipilimumab on specified days followed by nivolumab only on specified days
  • nivolumab
  • ipilimumab
Arm B: Standard of care chemotherapyActive ComparatorSpecified dose of gemcitabine / cisplatin or gemcitabine / carboplatin on specified days
  • gemcitabine
  • cisplatin
  • carboplatin
Arm C: Investigational immunotherapyExperimentalSpecified dose of nivolumab plus gemcitabine-cisplatin followed by nivolumab only on specified days
  • nivolumab
  • gemcitabine
  • cisplatin
Arm D: Standard of care chemotherapyActive ComparatorSpecified dose of gemcitabine-cisplatin only on specified days
  • gemcitabine
  • cisplatin

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS) in cisplatin-ineligible randomized participants
Time Frame:Up to 55 months
Safety Issue:
Description:Measured by time Only applies to primary study

Secondary Outcome Measures

Measure:Overall survival (OS) in all randomized participants
Time Frame:Up to 55 months
Safety Issue:
Description:Measured by time Applies to primary study
Measure: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
Safety Issue:
Description:Measured by time Applies to primary study
Measure: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
Safety Issue:
Description:Measured by EORTC QLQ-C30 Applies to primary study
Measure:OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC.
Time Frame:Up to 55 months
Safety Issue:
Description:Measured by time Applies to sub-study
Measure:European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score
Time Frame:Up to 55 months
Safety Issue:
Description:Applies to sub-study
Measure:PFS in PD-L1 positive by BICR (using RECIST 1.1)
Time Frame:Up to 55 months
Safety Issue:
Description:Applies to sub-study
Measure:OS by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC)
Time Frame:Up to 55 months
Safety Issue:
Description:Applies to sub-study

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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