CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 168 enrolled
Drug / intervention
nivolumab +2 morebiological
Likely dose
nivolumab 0.3 mg/kgfrom 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/NCT01354431
NCT01354431Phase 2Completed

A Randomized, Blinded, Phase 2 Dose-Ranging Study Of BMS-936558 (MDX-1106) In Subjects With Progressive, Advanced/Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

Bristol-Myers Squibb·interventional·Posted May 16, 2011·Updated May 12, 2022

In Brief

A Phase 2 clinical trial evaluating nivolumab for Renal Cell Carcinoma. Completed, enrolled 168 participants across 41 sites in 4 countries.

Detailed Summary

The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Finland, Italy, United States
CollaboratorsOno Pharma USA Inc

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2011
Enrollment StartMay 31, 2011
Primary CompletionMay 15, 2013
Study CompletionApr 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 15.1 years ago

Interventions

nivolumabbiological

Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons

nivolumabbiological

Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons

nivolumabbiological

Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons