Clinical Trial: Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell Carcinoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma
Brief Summary: 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, PD-1.
Detailed Summary:
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Current Primary Outcome: Safety and Tolerability (number of adverse events as a measure of toxicity) [ Time Frame: From the first dose of nivolumab treatment through 100 days post-surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Objective Tumor Response Rate (by RECIST) [ Time Frame: Assessed at baseline, prior to surgery, and 3 months after surgery ]Percentage of patients achieving a complete response (CR) or partial response (PR) by RECIST
- Objective Tumor Response Rate (by irRC) [ Time Frame: Assessed at baseline, prior to surgery, and 3 months after surgery ]Percentage of patients achieving a complete response (CR) or partial response (PR) by immune-related response criteria (irRC)
- Quality of Life (Median scores on FKSI-15 questionnaire) [ Time Frame: Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery ]
- Metastasis-Free Survival [ Time Frame: 12 months post-operatively, then every 6 months for 5 years ]
- Overall Survival [ Time Frame: 12 months post-operatively, then every 6 months for 5 years ]
Original Secondary Outcome: Same as current
Information By: Sidney Kimmel Comprehensive Cancer Center
Dates:
Date Received: October 6, 2015
Date Started: February 2016
Date Completion: December 2019
Last Updated: May 2, 2017
Last Verified: May 2017
