Clinical Trials /

A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

NCT03138512

Description:

The purpose of this study is to determine whether nivolumab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in patients who have experienced partial or entire removal of a kidney

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

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney
  • Official Title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

Clinical Trial IDs

  • ORG STUDY ID: CA209-914
  • SECONDARY ID: 2016-004502-34
  • NCT ID: NCT03138512

Conditions

  • Renal Cell Carcinoma

Interventions

DrugSynonymsArms
nivolumabOpdivoPart A, Arm A: nivolumab + ipilimumab
ipilimumabYervoyPart A, Arm A: nivolumab + ipilimumab
nivolumab placeboPart A, Arm B: nivolumab placebo + ipilimumab placebo
ipilimumab placeboPart A, Arm B: nivolumab placebo + ipilimumab placebo

Purpose

The purpose of this study is to determine whether nivolumab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in patients who have experienced partial or entire removal of a kidney

Detailed Description

      The study has two primary endpoints. The first primary completion date is anticipated to be
      reached Aug 2022 (DFS in Part A). The second primary completion date is anticipated to be
      reached July 2024 (DFS in Part B).
    

Trial Arms

NameTypeDescriptionInterventions
Part A, Arm A: nivolumab + ipilimumabExperimental
  • nivolumab
  • ipilimumab
Part A, Arm B: nivolumab placebo + ipilimumab placeboPlacebo Comparator
  • nivolumab placebo
  • ipilimumab placebo
Part B, Arm A: nivolumab + ipilimumabExperimental
  • nivolumab
  • ipilimumab
  • ipilimumab placebo
Part B, Arm B: nivolumab placebo + ipilimumab placeboPlacebo Comparator
  • nivolumab placebo
  • ipilimumab placebo
Part B, Arm C: nivolumab + ipilimumab placeboExperimental
  • nivolumab
  • nivolumab placebo
  • ipilimumab placebo

Eligibility Criteria

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

        Inclusion Criteria:

          -  Kidney tumor has been completely resected with randomization occurring 4 to 12 weeks
             prior to nephrectomy

          -  Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G
             any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0

          -  Post-nephrectomy tumor shows RCC with a predominantly clear cell histology, including
             participants with sarcomatoid features

          -  Participants must have no clinical or radiological evidence of macroscopic residual
             disease or distant metastases after nephrectomy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (0 - 1)

          -  Women and men must agree to follow methods of contraception

        Exclusion Criteria:

          -  Participants with an active known or suspected autoimmune disease

          -  Known history of positive test for human immunodeficiency virus (HIV) or known
             acquired immunodeficiency syndrome (AIDS)

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or
             any other antibody or drug specifically targeting T-cell con-stimulation or checkpoint
             pathways

          -  Any severe or serious, acute or chronic medical or psychiatric condition, or
             laboratory abnormality that may increase the risk associated with study participation

          -  History of allergy or hypersensitivity to study drug components

          -  Participants with a condition requiring systemic treatment with corticosteroids

          -  Participants who have received a live/attenuated vaccine within 30 days of first
             treatment

        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:Disease-free survival (DFS) as assessed by BICR (Part A and Part B)
Time Frame:Up to 10 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS) (Part A and Part B)
Time Frame:Up to 10 years
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs) (Part A and Part B)
Time Frame:Up to 10 years
Safety Issue:
Description:
Measure:Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C)
Time Frame:Up to 10 years
Safety Issue:
Description:

Details

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

Trial Keywords

  • localized
  • resected
  • adjuvant
  • Renal Cell Carcinoma
  • Kidney Cancer
  • Nephrectomy

Last Updated

March 3, 2020