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Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma

Phase II Trial of Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma (mRCC)

NCT02781506•University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

Nivolumab (brand name Opdivo): IV, administered per standard of care according to institutional guidelines at the discretion of the treating medical oncologist, until disease progression or unacceptable toxicity; SABR, dose variable, in 1-3 fractions.

Detailed Description

A single institution, safety lead-in phase II trial with SAbR to multiple metastatic sites concurrently administered with Nivolumab for patients with metastatic clear cell renal cell cancer who have failed at least one anti-angiogenic therapy.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 18 years of age
•Willing and able to provide consent
•Pathologic diagnosis of metastatic RCC with clear cell component
•Measurable disease in at least 2 non-radiated sites. Progression or intolerance to at least one prior systemic anti-angiogenic therapy.
•Eligible for extra-CNS SAbR to 1-6 sites of disease
•Must have received at least one prior anti-angiogenic therapy in the advanced or metastatic setting. Prior cytokine therapy (eg, IL-2, IFN-α), vaccine therapy, or treatment with cytotoxic therapy is also allowed but not any other drug specifically targeting T-cell co-stimulation or checkpoint pathways.
•Previous treatment with surgery, radiation, chemotherapy, targeted agents (see above) are allowed provided that: Chemotherapy/Major surgery was administered \> 14 days before the start Nivolumab; Minor surgery, radiation, or any targeted agents were administered \> 7 days before the start of Nivolumab
•Performance status ECOG 0, 1, 2 or 3.
•Adequate organ and marrow function as defined below (obtained within 14 days of first dose of drug):
•* leukocytes≥ 2,000/mcL
+12 more criteria

Exclusion Criteria

•Subjects who have had major surgery (such as nephrectomy) or chemotherapy within 2 weeks prior to first dose of drug
•Subjects who have had radiation therapy within 2 weeks prior to first dose of drug
•Uncontrolled adrenal insufficiency or active chronic liver disease
•Any history of CNS metastases that is not adequately treated with surgery or SABR \>14 days prior.
•Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
•Any positive history for HIV/AIDS, HTLV, hepatitis B or hepatitis C virus indicating acute or chronic infection.
•Any active known or suspected autoimmune disease. Subjects with 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 are permitted to enroll.
•Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalent are permitted (although not encouraged) in the absence of active autoimmune disease.
•Subjects with life expectancy \< 6 months
•Subjects receiving any other investigational or standard antineoplastic agents.
+4 more criteria

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Start Date

June 20, 2016

Primary Completion Date

May 24, 2021

Completion Date

May 24, 2021

Last Updated

August 8, 2022

Enrollment

ACTUAL participants

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Interventions

Nivolumab

DRUG

SAbR

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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