An Investigator-Initiated Trial of Combined Ipilimumab, Nivolumab and Stereotactic Radiation in Patients With Metastatic Clear-Cell RCC (ccRCC) Who Have Failed Treatment With Single-Agent Nivolumab

Medical University of South Carolina1 site in 1 countryApril 1, 2018

ConditionsClear Cell Renal Cell Carcinoma Metastatic Renal Cell Carcinoma

InterventionsNivolumab Ipilimumab Steriotactic radiation therapy

DrugsNivolumab Ipilimumab

Overview

Phase: Phase 2
Intervention: Nivolumab
Conditions: Clear Cell Renal Cell Carcinoma
Sponsor: Medical University of South Carolina
Locations: 1
Primary Endpoint: Number of patients with a partial or complete response
Status: Withdrawn
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to see if continued nivolumab with the addition of ipilimumab plus hypo-fractionated stereotactic radiation (sTR) of a single lesions results in partial or complete responses in patients with metastatic ccRCC who fail initial treatment with single agent nivolumab.

Registry

clinicaltrials.gov

Start Date

April 1, 2018

End Date

April 1, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medical University of South Carolina

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of metastatic ccRCC.
•Age 18 years and older
•Progressive disease after treatment with single-agent nivolumab
•Life expectancy at least 3 months
•Presence of measurable disease per RECIST 1.1 criteria
•Presence of a metastatic lesion greater than 1 cm in size that is amenable to radiation treatment
•Adequate organ system function
•WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.

Exclusion Criteria

•Patients are excluded if they have active brain metastases or leptomeningeal metastases (exceptions outlined in the protocol).
•Active, known or suspected autoimmune disease, such as systemic lupus erythematosus, that require treatment with immune suppressing drugs.
•Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
•Presence of a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration.
•Note: Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
•Unstable angina or uncontrolled congestive heart failure
•Uncontrolled hypercalcemia
•Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
•Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
•Presence of other malignant diseases, except non-melanoma skin care