CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 164 enrolled
Drug / intervention
Nivolumab 240 mg +3 moredrug
Likely dose
Nivolumab 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03117309
NCT03117309Phase 2Completed
CompareCT.gov

Phase II Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma. HCRN: GU16-260

Michael B. Atkins, MD·interventional·Posted Apr 17, 2017·Updated Jul 10, 2025

In Brief

A Phase 2 clinical trial evaluating Nivolumab 240 mg, Ipilimumab 1mg/kg, and 2 other interventions for Advanced Renal Cell Carcinoma. Completed, enrolled 164 participants across 12 sites.

Detailed Summary

Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Renal Cell Carcinoma
CountriesUnited States
CollaboratorsBristol-Myers Squibb, Hoosier Cancer Research Network

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 17, 2017
Enrollment StartApr 24, 2017
Primary CompletionMar 25, 2022
Study CompletionJan 23, 2025
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 9.2 years ago

Interventions

Nivolumab 240 mgdrug

PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment

Ipilimumab 1mg/kgdrug

Ipilimumab 1 mg/kg every 3 weeks x 4

Nivolumab 3mg/kgdrug

In combination with Ipilimumab

Nivolumab 360mgdrug

Continue Nivolumab 360 mg IV every 3 weeks