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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: Nivolumab (brand name Opdivo): IV, 3 mg/kg q2 weeks, until disease progression or unacceptable toxicity; SABR, dose variable, in 1-3 fractions.

Detailed Summary: 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.
Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: Response Rate (RR) [ Time Frame: 5 years ]

The primary objective of the randomized phase II trial will be to increase the RR of treatment with Nivolumab by the concurrent administration of SAbR. The assessment of RR will be based on the evaluation of irRECIST criteria and radiated lesions will be excluded from target lesions.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival [ Time Frame: 5 years ]
    To evaluate and compare the overall survival (OS), which is defined as the time between date of registration and the date of death due to any cause, between the Nivolumab alone and the combination therapy arms
  • Progression free survival [ Time Frame: 5 years ]
    To evaluate and compare progression free survival (PFS), which is defined as the time between date of registration and the first date of documented disease progression or date of death due to any cause, between the Nivolumab alone and the combination therapy arms
  • Complete response rate [ Time Frame: 5 years ]
    To evaluate and compare complete response rate in each arm, which is defined as the percentage of patients who show complete response as per ir-RECIST criteria
  • Time to progression [ Time Frame: 5 years ]
    To evaluate and compare time to progression (TTP), which is defined as time between date of registration and date of documented progression, between the experimental and control arms.
  • Median response duration [ Time Frame: 5 years ]
    To evaluate and compare median response duration, which is defined as the time between the date a response (CR or PR) was first seen until date of progression, between the two arms
  • Toxicity [ Time Frame: 5 years ]
    To evaluate the tolerability and toxicity in each arm as measured according to CTCAE v4.0.
  • Health-related quality of life [ Time Frame: 5 years ]
    To compare health-related quality of life (HR-QoL) between the experimental and control arms.
  • immunogenicity [ Time Frame: 5 years ]
    To measure and compare treatment-related tumor-specific immune response (immunogenicity) in each arm
  • Immunological biomarkers [ Time Frame: 5 years ]
    To identify immunological biomarkers as predictors of treatment response or resistance.
  • Cost-effectiveness [ Time Frame: 5 years ]
    To evaluate the cost-effectiveness and cost-utility of the addition of SAbR to Nivolumab in patients with mRCC


Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: May 19, 2016
Date Started: June 2016
Date Completion: December 2022
Last Updated: November 18, 2016
Last Verified: November 2016