Clinical Trials /

A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread

NCT04810078

Description:

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread.

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
  • Official Title: A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy

Clinical Trial IDs

  • ORG STUDY ID: CA209-67T
  • SECONDARY ID: 2020-003655-15
  • SECONDARY ID: U1111-1255-9514
  • NCT ID: NCT04810078

Conditions

  • Clear Cell Renal Cell Carcinoma

Interventions

DrugSynonymsArms
Nivolumab and rHuPH20BMS-986298Arm A: Subcutaneous Nivolumab
NivolumabOpdivo, BMS-936558Arm B: Intravenous Nivolumab

Purpose

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread.

Trial Arms

NameTypeDescriptionInterventions
Arm A: Subcutaneous NivolumabExperimental
  • Nivolumab and rHuPH20
Arm B: Intravenous NivolumabActive Comparator
  • Nivolumab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Histological confirmation of renal cell carcinoma (RCC) with a clear cell component,
             including participants who may also have sarcomatoid features

          -  Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC
             (Stage IV)

          -  Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST)
             v1.1 criteria within 28 days prior to randomization

          -  Received no more than 2 prior systemic treatment regimens

          -  Intolerance or progression on or after the last treatment regimen received and within
             6 months prior to randomization on the study

          -  Karnofsky PS ≥ 70 at screening

          -  Must agree to follow specific methods of contraception, if applicable

        Exclusion Criteria:

          -  Untreated, symptomatic central nervous system (CNS) metastases

          -  Concurrent malignancy (present during screening) requiring treatment or history of
             prior malignancy active within 2 years prior to randomization

          -  Active, known, or suspected autoimmune disease

          -  Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency
             syndrome (AIDS) defining opportunistic infection within the last year, or a current
             CD4 count < 350 cells/μL. Participants with HIV are eligible if:

               1. They have received established antiretroviral therapy (ART) for at least 4 weeks
                  prior to randomization

               2. They continue on ART as clinically indicated while enrolled on study

               3. CD4 counts and viral load are monitored per standard of care by a local health
                  care provider

               4. Inclusion of participants with HIV should be based on Investigator clinical
                  judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be
                  performed at sites where mandated locally. HIV-positive participants must be
                  excluded where mandated locally

          -  Serious or uncontrolled medical disorders including for example, active severe acute
             respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks
             prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must
             have resolved based on investigator clinical judgment and, in consultation with
             Medical Monitor, there are no sequelae that would place the participant at a higher
             risk of receiving investigational treatment to be eligible

          -  Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death
             ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4)
             antibody, or any other antibody or drug specifically targeting T-cell costimulation or
             checkpoint pathways

          -  Treatment with any live attenuated vaccine within 30 days of first study treatment

        Other protocol-defined inclusion/exclusion criteria apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Time-averaged serum concentration over 28 days (Cavgd28)
Time Frame:Up to 28 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up
Time Frame:Up to 2 years 6 months
Safety Issue:
Description:
Measure:Trough serum concentration at day 28 (Cmind28)
Time Frame:At 28 days
Safety Issue:
Description:
Measure:Maximum serum concentration after the first dose (Cmax1)
Time Frame:Up to 7 days
Safety Issue:
Description:
Measure:Time to peak serum concentration after the first dose (Tmax1)
Time Frame:Up to 7 days
Safety Issue:
Description:
Measure:Peak serum concentration at steady-state (Cmaxss)
Time Frame:Up to 4 months
Safety Issue:
Description:
Measure:Steady-state average serum concentration (Cavgss)
Time Frame:Up to 4 months
Safety Issue:
Description:
Measure:Incidence of adverse events (AEs)
Time Frame:Up to 2 years 3 months
Safety Issue:
Description:
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Up to 2 years 3 months
Safety Issue:
Description:
Measure:Incidence of AEs leading to discontinuation
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame:Up to 2 years 3 months
Safety Issue:
Description:
Measure:Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Time Frame:Up to 2 years 3 months
Safety Issue:
Description:
Measure:Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up
Time Frame:Up to 2 years 6 months
Safety Issue:
Description:
Measure:Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Efficacy parameters: DCR by BICR at end of study
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up
Time Frame:Up to 2 years 6 months
Safety Issue:
Description:
Measure:Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Efficacy parameters: DOR by BICR at end of study
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up
Time Frame:Up to 2 years 6 months
Safety Issue:
Description:
Measure:Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Efficacy parameters: TTR by BICR at end of study
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up
Time Frame:Up to 2 years 6 months
Safety Issue:
Description:
Measure:Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Efficacy parameters: PFS by BICR at end of study
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up
Time Frame:Up to 2 years 6 months
Safety Issue:
Description:
Measure:Efficacy parameters: OS with a minimum of 12 months follow-up
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Efficacy parameters: OS at end of study
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Efficacy parameters: ORR by BICR at end of study
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions
Time Frame:Up to 2 years 3 months
Safety Issue:
Description:
Measure:Incidence of local injection- or infusion-site reactions
Time Frame:Up to 2 years 3 months
Safety Issue:
Description:
Measure:Percentage of participants who develop anti-nivolumab antibodies, if applicable
Time Frame:Up to 2 years 3 months
Safety Issue:
Description:
Measure:Percentage of participants who develop neutralizing antibodies, if applicable
Time Frame:Up to 2 years 3 months
Safety Issue:
Description:

Details

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

Trial Keywords

  • BMS-936558
  • BMS-986298
  • Clear cell renal cell carcinoma
  • ccRCC
  • Nivolumab
  • Opdivo
  • rHuPH20
  • Subcutaneous

Last Updated

July 26, 2021