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

Phase 1

Completed

• Conditions: Clear Cell Renal Cell Carcinoma
• Interventions: Drug: Nivolumab

• Registration Number: NCT02575222
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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, Programmed cell death-1 (PD-1).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-14
• Study Start: 2016-02
• Status Verified: 2020-06
• Primary Completion: 2020-06-09
• Study Completion: 2020-06-09
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab	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 Measures

Name	Time	Method
Safety as assessed by number of participants experiencing adverse events	From the first dose of nivolumab treatment through 100 days post-surgery	Number of participants experiencing any adverse event as defined by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

Secondary Outcome Measures

Name	Time	Method
Objective Tumor Response Rate (by irRC)	Assessed at baseline, prior to surgery, and 3 months after surgery	Number of patients achieving a complete response (CR) or partial response (PR) by immune-related response criteria (irRC)
Metastasis-Free Survival	12 months post-operatively, then every 6 months for 5 years	Number of months without evidence of metastasis.
Objective Tumor Response Rate (by RECIST)	Assessed at baseline, prior to surgery, and 3 months after surgery	Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST)
Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire	Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery	Total score range 0-60 with higher scores indicating a less symptomatic respondent.
Overall Survival	12 months post-operatively, then every 6 months for 5 years	Number of months alive.

Trial Locations

Locations (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States