Phase 2
Completed N=104
An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
Source: ClinicalTrials.gov NCT03029780 ↗Enrolled (actual)
104
Serious AEs
50.0%
Results posted
Dec 2018
Primary outcomePrimary: The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination Period — 11.5; 11.5 Percentage of Participants
Summary
The purpose of this study is to evaluate safety and efficacy of different administration regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination Period |
11.5; 11.5 | — |
| SECONDARY The Percentage of Participant With Adverse Events in the Narrow Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Occurring Within 2 Days After Any Dose in the Combination Period |
0; 0 | — |
| SECONDARY The Percentage of Participants With Drug Related Grade 3-5 Adverse Events |
48.1; 42.3 | — |
| SECONDARY The Percentage of Participants With All Causality Grade 3-5 Adverse Events |
73.1; 65.4 | — |
| SECONDARY Objective Response Rate (ORR) |
50.0; 32.7 | — |
| SECONDARY Progression Free Survival (PFS) |
12.06; 7.69 | — |
| SECONDARY Geometric Mean Trough Concentrations of Nivolumab and Ipilimumab |
3.92; 3.43; 5.90; 5.39; 16.2; 16.1 | — |
| SECONDARY Geometric Mean End of Infusion (EOI) Concentrations of Nivolumab and Ipilimumab |
17.6; 13.4; 21.4; 15.6; 24.9; 19.5 | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Advanced Renal Cell Carcinoma
- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
- Must have at least 1 lesion with measurable disease
Exclusion Criteria
- Subjects with active central nervous system metastases
- Subjects who received prior therapy with checkpoint inhibitor
- Subjects with active, known or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03029780). 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. Informational only — not medical advice.