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Anti-tumor antibiotic
Stereotactic Radiation + Immunotherapy for Kidney Cancer (SAMURAI Trial)
Phase 2
Recruiting
Led By William A Hall
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status >= 60 within 45 days prior to registration
For patients with chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to last follow-up, up to 8 years
Awards & highlights
SAMURAI Trial Summary
This trial tests whether adding radiation to standard immunotherapy improves outcomes for patients with metastatic renal cell cancer.
Who is the study for?
Adults with unresectable or metastatic renal cell cancer, eligible for standard immunotherapy or immunotherapy-VEGF combinations. They must have adequate organ function, no severe comorbidities, and not be recommended for kidney removal surgery. Prior cancers are okay if they don't affect the trial's safety or results. Participants need to use effective contraception and provide informed consent.Check my eligibility
What is being tested?
The SAMURAI study is testing if adding Stereotactic Ablative Radiation Therapy (SABR) to standard immune therapies like nivolumab improves outcomes in patients with advanced kidney cancer. SABR targets tumors precisely with high-energy photons, potentially causing less damage to healthy tissue.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation therapy such as skin irritation and fatigue, along with immune therapy-related issues like inflammation of organs, infusion reactions, autoimmune conditions, and increased risk of infections.
SAMURAI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
Select...
My chronic hepatitis B virus infection is under control with treatment.
Select...
My kidney tumor is 8 cm or smaller in one specific measurement.
Select...
My kidney cancer diagnosis was confirmed through lab tests.
Select...
My cancer has spread to lymph nodes and cannot be removed by surgery, or it has spread to other parts of my body.
Select...
I am 18 years old or older.
Select...
I am eligible for standard cancer treatment involving immune therapy alone or with VEGF inhibitors.
Select...
I am not advised to or have refused kidney surgery for cancer reduction.
Select...
My cancer can be measured and is not just in my kidneys.
Select...
I had hepatitis C but have been successfully treated and cured.
SAMURAI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to last follow-up, up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to last follow-up, up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nephrectomy and radiographic progression-free survival (nrPFS)
Secondary outcome measures
Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified reasons (nrPFS2)
Overall survival
Percentage of participants who undergo cytoreductive nephrectomy
+6 moreSAMURAI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (SABR, standard of care immunotherapy)Experimental Treatment8 Interventions
Patients undergo SABR on 3 different days over 1-3 weeks and receive immunotherapy as in Arm I.
Group II: Arm I (standard of care immunotherapy)Active Control7 Interventions
Patients receive one of the following immunotherapy regimens per physician discretion: nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes every 3 weeks for 4 doses followed by nivolumab IV over 30 minutes every 2 or 4 weeks; pembrolizumab IV over 30 minutes every 3 or 6 weeks and axitinib PO BID; avelumab IV over 60 minutes every 2 weeks and axitinib PO BID; nivolumab IV over 30 minutes every 2 or 4 weeks and cabozantinib PO QD; OR pembrolizumab IV over 30 minutes every 3 or 6 weeks and lenvatinib PO QD. Treatment with immunotherapy continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Axitinib
2020
Completed Phase 2
~3050
Cabozantinib
2020
Completed Phase 2
~1080
Avelumab
2018
Completed Phase 2
~2450
Ipilimumab
2014
Completed Phase 3
~2620
Lenvatinib
2005
Completed Phase 4
~2690
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,612 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,893 Total Patients Enrolled
William A HallPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may need occasional help.I have brain metastases that are either untreated or not stable.My chronic hepatitis B virus infection is under control with treatment.My kidney tumor is 8 cm or smaller in one specific measurement.My hemoglobin level is at least 8 g/dL, even if I needed a transfusion.My kidney was exposed to radiation during my cancer treatment.I do not have severe health issues like uncontrolled high blood pressure, recent major surgery, serious heart problems, or untreated blood clots.My kidney cancer diagnosis was confirmed through lab tests.My cancer has spread to lymph nodes and cannot be removed by surgery, or it has spread to other parts of my body.Your liver enzyme levels are not too high, unless you have liver cancer that has spread.I am HIV positive, on treatment, and my viral load is undetectable.Your platelet count is at least 50,000 per cubic millimeter within the 45 days before joining the study.Your white blood cell count is at least 1500 per cubic millimeter.I am scheduled for treatment aimed at curing all my cancer that has spread.I have not had systemic therapy for metastatic kidney cancer, except chemotherapy for another cancer over 3 years ago.I am 18 years old or older.I am eligible for standard cancer treatment involving immune therapy alone or with VEGF inhibitors.Your kidneys are working well enough, with a certain amount of creatinine cleared from your blood.I have another cancer that does not affect my current treatment's safety or effectiveness.I am not advised to or have refused kidney surgery for cancer reduction.Patients must have a moderate or poor prognosis for their disease, based on specific factors.My cancer can be measured and is not just in my kidneys.I had hepatitis C but have been successfully treated and cured.Your total bilirubin level should be no more than 1.5 times the upper limit of normal, unless you have Gilbert Syndrome, in which case it can be up to 3.0 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (standard of care immunotherapy)
- Group 2: Arm II (SABR, standard of care immunotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being accepted into this research trial?
"According to the data on clinicaltrials.gov, this clinical trial is looking for subjects as we speak. The study was first posted on 6/30/2022 and updated just last week on 7/29/2022."
Answered by AI
How many people fit the requirements to be in this clinical trial?
"That is correct. The clinicaltrial.gov website lists this trial as currently open and recruiting patients. This study was first posted on June 30th, 2022 and was last updated on July 29th, 2022. There are 5 different sites enrolling a total of 240 participants."
Answered by AI
In how many different healthcare facilities is this research project being conducted presently?
"The trial is currently running at 5 locations, which include the Carle Cancer Institute in Mattoon, Carle Physician Group-Mattoon/Charleston in Danville, and Carle on Vermilion in Effingham."
Answered by AI
Has Stereotactic Ablative Radiotherapy undergone regulatory approval by the FDA?
"There is only some data supporting the safety of Stereotactic Ablative Radiotherapy, as this treatment is still in Phase 2 clinical trials. This means that while there have been no reports of serious adverse effects, it is unclear whether or not the treatment is effective."
Answered by AI
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