Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen

Sponsor
UNICANCER
Study ID
NCT03013335
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    The dose and schedule of nivolumab in this study will be 3 mg/kg every 2 weeks. Infusion of nivolumab will be performed in 30 minutes (± 5 minutes). Nivolumab will be administered every 2 weeks until death, disease progression, unacceptable toxicity or withdrawal of the informed consent

Study Details

The primary objective of this study is to evaluate the incidence of high-grade (i.e. Grade 3-4 and Grade 5 of CTCAE v4.0) adverse reactions of interest in patients with metastatic RCC who have progressed during or after receiving at least one prior systemic anti-angiogenic treatment and who are eligible for nivolumab monotherapy.

Key Dates

Start date
Jan 31, 2016
Status verified
Oct 2021
Primary completion
Jun 30, 2018
Completion
Jun 30, 2021

Study Design

Enrollment
730 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    The dose and schedule of nivolumab in this study will be 3 mg/kg every 2 weeks. Infusion of nivolumab will be performed in 30 minutes (± 5 minutes). Nivolumab will be administered every 2 weeks until death, disease progression, unacceptable toxicity or withdrawal of the informed consent

Primary Outcome Measure

Incidence for high-grade (Grade3-4-5) adverse reactions of interest [ Time Frame: 5 years ]

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