Phase 3
N=1,641
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
Carcinoma, Renal Cell
Bottom Line
View on ClinicalTrials.gov: NCT03138512 ↗Enrolled (actual)
1,641
Serious AEs
18.5%
Results posted
Dec 2024
Primary outcome: Primary: Disease-Free Survival (DFS) by BICR - Treatment Part A and B — NA; NA; NA; NA Months — p=0.6676
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- nivolumab (Biological); ipilimumab (Biological); nivolumab placebo (Drug); ipilimumab placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-Free Survival (DFS) by BICR - Treatment Part A and B |
NA; NA; NA; NA | 0.6676 |
| SECONDARY Overall Survival (OS) - Treatment Part A and B |
NA; NA; NA; NA | 0.2436 |
| SECONDARY Overall Survival (OS) Rate (5 Years) - Treatment Part A and B |
85.0; 87.2 | — |
| SECONDARY Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B |
NA; NA | — |
| SECONDARY Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B |
NA; NA | — |
| SECONDARY The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A |
392; 362; 154; 44; 1; 0 | — |
| SECONDARY The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B |
193; 182; 362; 59; 31; 70 | — |
| SECONDARY The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A |
393; 365; 167; 52; 4; 1 | — |
| SECONDARY The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B |
196; 182; 367; 68; 32; 85 | — |
| SECONDARY The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A |
1; 1; 1; 0; 0; 0 | — |
| SECONDARY The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B |
0; 3; 0; 0; 1; 0 | — |
| SECONDARY The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A |
1; 1; 1; 0; 0; 0 | — |
| SECONDARY The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B |
2; 3; 1; 0; 1; 0 | — |
Summary
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.
Eligibility Criteria
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 tumor, node, and metastasis (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 renal cell cancer (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 (PS) 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 co-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
Data sourced from ClinicalTrials.gov (NCT03138512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.