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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Safety as assessed by number of participants experiencing adverse events
Number of participants experiencing any adverse event as defined by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Time frame: From the first dose of nivolumab treatment through 100 days post-surgery
Objective Tumor Response Rate (by RECIST)
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Assessed at baseline, prior to surgery, and 3 months after surgery
Objective Tumor Response Rate (by irRC)
Number of patients achieving a complete response (CR) or partial response (PR) by immune-related response criteria (irRC)
Time frame: Assessed at baseline, prior to surgery, and 3 months after surgery
Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire
Total score range 0-60 with higher scores indicating a less symptomatic respondent.
Time frame: Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery
Metastasis-Free Survival
Number of months without evidence of metastasis.
Time frame: 12 months post-operatively, then every 6 months for 5 years
Overall Survival
Number of months alive.
Time frame: 12 months post-operatively, then every 6 months for 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.