Trial intelligence / Profile preview

Nivolumab safety in advanced renal cell carcinoma

NCT02596035Phase 4

Key facts

Status: Completed
Start: Jan 2016
Primary completion: Mar 2018
Countries: 1
Sponsor: Bristol Myers Squibb
Modality: Monoclonal Antibodies

Drugs: nivolumab
Conditions: renal cell carcinoma (RCC)

Overview

Phase 4, open-label, single-arm trial of nivolumab in renal cell carcinoma (RCC), sponsored by Bristol Myers Squibb. Primary endpoint: Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events at 100 days. Started Jan 2016; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Nivolumab
Nivolumab monotherapy

Who it enrols

Patients with advanced or metastatic RCC. Clear cell histology requires 1-2 prior anti-VEGF treatments and no more than 3 total prior regimens. Non-clear cell histology allows 0-3 prior systemic therapies. Brain metastases allowed if asymptomatic. KPS >= 70%.

Endpoints

Primary

Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events100 days

Secondary

Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events100 days
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events4 years 7 months
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)100 days
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event100 days
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event4 years 9 months
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication100 days

Beyond the preview

Go deeper on NCT02596035.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT02596035.