Phase 2
Completed N=182
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
Source: ClinicalTrials.gov NCT02996110 ↗Enrolled (actual)
182
Serious AEs
54.7%
Results posted
Dec 2022
Primary outcomePrimary: Objective Response Rate (ORR) Per Investigator — 20; 30; 17.4; 3.1 Percent of participants
Summary
The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Per Investigator |
20; 30; 17.4; 3.1; 3.2; 9.5 | — |
| PRIMARY Median Duration of Response (DOR) Per Investigator |
NA; 32.57; 68.00; 99.4; NA; NA | — |
| PRIMARY Progression Free Survival Rate (PFSR) at 24 Weeks. |
0.491; 0.429; 0.432; 0.194; 0.278; 0.468 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
29; 30; 45; 32; 31; 19 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
17; 15; 28; 16; 16; 9 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Leading to Discontinuation |
7; 7; 10; 3; 6; 2 | — |
| SECONDARY Number of Participants Who Died |
12; 15; 27; 17; 13; 10 | — |
| SECONDARY Number of Participants With Abnormal Thyroid Test Results - Track 1 |
8; 8; 0; 0; 0; 5 | — |
| SECONDARY Number of Participants With Abnormal Thyroid Test Results - Track 2 |
14; 14; 6; 3; 4; 8 | — |
| SECONDARY Number of Participants With Abnormal Hepatic Test Results - Track 1 |
2; 4; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Abnormal Hepatic Test Results - Track 2 |
3; 1; 1; 0; 0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Advanced Renal Cell Carcinoma
- Must have at least 1 lesion with measurable disease
- Life expectancy of at least 3 months
- Karnofsky Performance Status (KPS) must be =>70%
Exclusion Criteria
- Patients/subjects with suspected or known central nervous system metastases unless adequately treated
- Patients/subjects with autoimmune disease
- Patients/subjects who need daily oxygen therapy
Other protocol defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02996110). 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.