Description:
The purpose of this study is to determine whether nivolmab alone or the combination of
nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing
recurrence of cancer in participants who have experienced partial or entire removal of a
kidney.
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
Interventions
| Drug | Synonyms | Arms |
|---|
| nivolumab | Opdivo | Part A, Arm A: nivolumab + ipilimumab |
| ipilimumab | Yervoy | Part A, Arm A: nivolumab + ipilimumab |
| nivolumab placebo | | Part A, Arm B: nivolumab placebo + ipilimumab placebo |
| ipilimumab placebo | | Part A, Arm B: nivolumab placebo + ipilimumab placebo |
Purpose
The purpose of this study is to determine whether nivolmab alone or the combination of
nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing
recurrence of cancer in participants 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
| Name | Type | Description | Interventions |
|---|
| Part A, Arm A: nivolumab + ipilimumab | Experimental | | |
| Part A, Arm B: nivolumab placebo + ipilimumab placebo | Placebo Comparator | | - nivolumab placebo
- ipilimumab placebo
|
| Part B, Arm A: nivolumab + ipilimumab | Experimental | | - nivolumab
- ipilimumab
- ipilimumab placebo
|
| Part B, Arm B: nivolumab placebo + ipilimumab placebo | Placebo Comparator | | - nivolumab placebo
- ipilimumab placebo
|
| Part B, Arm C: nivolumab + ipilimumab placebo | Experimental | | - 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 negative surgical margins obtained. The
randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks
from the date of nephrectomy
- Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G
any, N0 M0; pT3, (a, b, c), 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 must agree to follow methods of contraception, if applicable
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 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 100 days after the last dose of study treatment |
| 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
- Clear cell
- High Risk of Relapse/Recurrence
Last Updated
August 2, 2021
