| Study name |
‐ |
| Methods |
Study type: RCT, parallel assignment, phase IIIB
Blinding: quadruple blinding (participant, care provider, investigator, outcomes assessor)
Accrual period: April 29, 2019 ‐ April 19, 2025 (estimated study completion date)
Countries: multicentre (80 study locations)
Cross‐over study: no
Status: active, not recruiting (as of February 10, 2022) |
| Participants |
Estimated enrolment: N=418
Inclusion criteria:
histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC) measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria no prior systemic therapy for RCC must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC) all sexes, older than 18 years
Exclusion criteria:
any active central nervous system (CNS) metastases active, known, or suspected autoimmune disease prior treatment with an anti‐PD‐1, anti‐PD‐L1, anti‐PD‐L2, anti‐CD137, anti‐CTLA‐4 antibody, or any other agents specifically targeting T‐cell co‐stimulation or checkpoint pathways
*Other protocol‐defined inclusion/exclusion criteria apply |
| Interventions |
Experimental arm I: Nivolumab
Experimental arm II: Ipilimumab
Control arm: Ipilimumab placebo |
| Outcomes |
Primary outcome(s)
Secondary outcome(s)
OS (time frame: up to 4 years) PFS by investigator (time frame: up to 4 years) Progression free survival secondary objective (PFS2) by investigator (time frame: up to 4 years9 Incidence of AEs (time frame: up to 4 years) Incidence of SAEs (time frame: up to 4 years)
Relevant to this review but not reported: QoL, TFST, number of patients who discontinued treatment
Other outcomes (not relevant to this review): ORR, DCR, DoR, TTR, clinical laboratory results |
| Starting date |
April 29, 2019 |
| Contact information |
‐ |
| Notes |
Funding source: Bristol‐Myers Squibb |
