Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell Carcinoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT02575222
Phase
PHASE1
Status
Completed

Conditions

  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.

Study Details

This study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1).

Key Dates

Start date
Feb 29, 2016
Status verified
Jun 2020
Primary completion
Jun 9, 2020
Completion
Jun 9, 2020

Study Design

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

Arms

  • Experimental: Nivolumab
    3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.

Primary Outcome Measure

Safety as assessed by number of participants experiencing adverse events [ Time Frame: From the first dose of nivolumab treatment through 100 days post-surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287-

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The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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