Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country17 target enrollmentFebruary 2016

ConditionsClear Cell Renal Cell Carcinoma

InterventionsNivolumab

DrugsNivolumab

Overview

Phase: Phase 1
Intervention: Nivolumab
Conditions: Clear Cell Renal Cell Carcinoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Enrollment: 17
Locations: 1
Primary Endpoint: Safety as assessed by number of participants experiencing adverse events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

June 9, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

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.

Intervention: Nivolumab

Outcomes

Primary Outcomes

Safety as assessed by number of participants experiencing adverse events

Time Frame: 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 Outcomes

Objective Tumor Response Rate (by irRC)(Assessed at baseline, prior to surgery, and 3 months after surgery)
Metastasis-Free Survival(12 months post-operatively, then every 6 months for 5 years)
Objective Tumor Response Rate (by RECIST)(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(Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery)
Overall Survival(12 months post-operatively, then every 6 months for 5 years)