Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02781506|
Recruitment Status : Recruiting
First Posted : May 24, 2016
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Clear Cell Renal Cell Carcinoma||Drug: Nivolumab Radiation: SAbR||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma (mRCC)|
|Actual Study Start Date :||June 20, 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2022|
Experimental: Nivolumab and SABR
Nivolumab alone: IV, 3 mg/kg q2 weeks, until disease progression or unacceptable toxicity. SABR, dose variable, in 1-3 fractions.
Nivolumab IV, 3 mg/kg q2 weeks
Other Name: Opdivo
SAbR (1-3 lesions)
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781506
|Contact: Raquibu Hannan, MD, PhD||214-645-8525|
|Contact: Kels W Kaiser, MS||214-648-1892||Kels.Kaiser@utsouthwestern.edu|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Raquibul Hannan, MD 214-645-8525|
|Contact: Jean Wu, MSN 214-645-8525|
|Principal Investigator: Raquibul Hannan, MD, PhD|
|Principal Investigator:||Raquibu Hannan, MD, PhD||UT Southwestern Medical Center at Dallas|