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Trial record 1 of 117 for:    A Phase II Trial of Stereotactic Body Radiation Therapy in Combination
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SBRT (Stereotactic Body Radiation Therapy) in Combination With Nivolumab/Ipilimumab in Renal Cell Carcinoma (RCC) / Kidney Cancer Patients (RADVAX)

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ClinicalTrials.gov Identifier: NCT03065179
Recruitment Status : Completed
First Posted : February 27, 2017
Results First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Hans Hammers, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Kidney Cancer Metastatic
Kidney Cancer
Kidney Cancer, Stage IV
Interventions Drug: Nivolumab/Ipilimumab
Radiation: SBRT
Enrollment 29
Recruitment Details There were 4 participants who signed the informed consent and went through the screening process as part of the protocol and were screen failures.
Pre-assignment Details  
Arm/Group Title Nivolumab/Ipilimumab Plus SBRT
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Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy

Nivolumab/Ipilimumab: IV immunotherapy

SBRT: SBRT will be delivered in conjunction with immunotherapy

Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Nivolumab/Ipilimumab Plus SBRT
Hide Arm/Group Description

Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy

Nivolumab/Ipilimumab: IV immunotherapy

SBRT: SBRT will be delivered in conjunction with immunotherapy

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
57
(35 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
2
   8.0%
Male
23
  92.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
1
   4.0%
Asian
1
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
23
  92.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants With Treatment-related Adverse Events Grade 3 or Higher as Assessed by CTCAE v4.0
Hide Description An adverse event (AE) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame up to 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nivolumab/Ipilimumab Plus SBRT
Hide Arm/Group Description:

Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy

Nivolumab/Ipilimumab: IV immunotherapy

SBRT: SBRT will be delivered in conjunction with immunotherapy

Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
9
  36.0%
2.Primary Outcome
Title Number of Participants Needing Corticosteroids
Hide Description [Not Specified]
Time Frame up to 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nivolumab/Ipilimumab Plus SBRT
Hide Arm/Group Description:

Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy

Nivolumab/Ipilimumab: IV immunotherapy

SBRT: SBRT will be delivered in conjunction with immunotherapy

Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
10
  40.0%
3.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description The ORR is defined as the number of participants with a BOR of CR (Complete response) or PR (Partial response) divided by the number of treated participants. The BOR (Best overall response) is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of first subsequent anti-cancer therapy including radiotherapy, tumor-directed surgery, or systemic anticancer therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment
Time Frame up to 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nivolumab/Ipilimumab Plus SBRT
Hide Arm/Group Description:

Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy

Nivolumab/Ipilimumab: IV immunotherapy

SBRT: SBRT will be delivered in conjunction with immunotherapy

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
56
(38.7 to 78.9)
Time Frame Up to 35 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nivolumab/Ipilimumab Plus SBRT
Hide Arm/Group Description

Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy

Nivolumab/Ipilimumab: IV immunotherapy

SBRT: SBRT will be delivered in conjunction with immunotherapy

All-Cause Mortality
Nivolumab/Ipilimumab Plus SBRT
Affected / at Risk (%)
Total   0/25 (0.00%) 
Hide Serious Adverse Events
Nivolumab/Ipilimumab Plus SBRT
Affected / at Risk (%)
Total   9/25 (36.00%) 
Gastrointestinal disorders   
Diarrhea   1/25 (4.00%) 
Colitis   1/25 (4.00%) 
ALT (Alanine Transaminase)   1/25 (4.00%) 
AST (Aspartate transaminase)   1/25 (4.00%) 
Amylase   6/25 (24.00%) 
Lipase   6/25 (24.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nivolumab/Ipilimumab Plus SBRT
Affected / at Risk (%)
Total   25/25 (100.00%) 
Endocrine disorders   
Hypothyroidism   8/25 (32.00%) 
Hyperthyroidism   3/25 (12.00%) 
Adrenal Insufficiency   4/25 (16.00%) 
Hypophysitis   1/25 (4.00%) 
Gastrointestinal disorders   
Diarrhea   14/25 (56.00%) 
Colitis   1/25 (4.00%) 
ALT   3/25 (12.00%) 
AST   3/25 (12.00%) 
Amylase   5/25 (20.00%) 
General disorders   
Fatigue   25/25 (100.00%) 
Musculoskeletal and connective tissue disorders   
Arthritis   2/25 (8.00%) 
Renal and urinary disorders   
Creatinine   1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonitis   2/25 (8.00%) 
Radiation Pneumonitis   2/25 (8.00%) 
Skin and subcutaneous tissue disorders   
Rash   8/25 (32.00%) 
Pruritus   6/25 (24.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hans Hammers
Organization: UT Southwestern Medical Center
Phone: 214/645-7445
EMail: Hans.Hammers@UTSouthwestern.edu
Layout table for additonal information
Responsible Party: Hans Hammers, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03065179    
Other Study ID Numbers: STU 072016-044
First Submitted: February 7, 2017
First Posted: February 27, 2017
Results First Submitted: December 28, 2020
Results First Posted: March 30, 2021
Last Update Posted: March 30, 2021