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Anti-tumor antibiotic

Stereotactic Radiation + Immunotherapy for Kidney Cancer (SAMURAI Trial)

Canton, MI
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
Must not have
Patients with untreated or unstable brain metastases or cranial epidural disease
Prior radiotherapy to the kidney resulting in overlap of radiation therapy fields treatment of the primary tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to last follow-up, up to 8 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests whether adding radiation to standard immunotherapy improves outcomes for patients with metastatic renal cell cancer.

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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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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My chronic hepatitis B virus infection is under control with treatment.
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My kidney tumor is 8 cm or smaller in one specific measurement.
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My kidney cancer diagnosis was confirmed through lab tests.
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My cancer has spread to lymph nodes and cannot be removed by surgery, or it has spread to other parts of my body.
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I am 18 years old or older.
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I am eligible for standard cancer treatment involving immune therapy alone or with VEGF inhibitors.
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I am not advised to or have refused kidney surgery for cancer reduction.
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My cancer can be measured and is not just in my kidneys.
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I had hepatitis C but have been successfully treated and cured.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases that are either untreated or not stable.
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My kidney was exposed to radiation during my cancer treatment.
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I do not have severe health issues like uncontrolled high blood pressure, recent major surgery, serious heart problems, or untreated blood clots.
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I am scheduled for treatment aimed at curing all my cancer that has spread.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to last follow-up, up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up, up to 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Nephrectomy and radiographic progression-free survival (nrPFS)
Secondary study objectives
Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified reasons (nrPFS2)
Overall survival
Percentage of participants with complete or partial response
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Cabozantinib
2020
Completed Phase 2
~2340
Ipilimumab
2015
Completed Phase 3
~3380
Lenvatinib
2017
Completed Phase 4
~2070
Axitinib
2020
Completed Phase 2
~3050
Avelumab
2017
Completed Phase 2
~2450
Pembrolizumab
2017
Completed Phase 3
~2630
Nivolumab
2014
Completed Phase 3
~3880

Find a Location

Closest Location:Trinity Health IHA Medical Group Hematology Oncology - Canton· Canton, MI

Who is running the clinical trial?

NRG OncologyLead Sponsor
241 Previous Clinical Trials
103,384 Total Patients Enrolled
National Cancer Institute (NCI)NIH
14,028 Previous Clinical Trials
41,152,873 Total Patients Enrolled
William A HallPrincipal InvestigatorNRG Oncology

Media Library

Avelumab (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05327686 — Phase 2
Kidney Cancer Research Study Groups: Arm I (standard of care immunotherapy), Arm II (SABR, standard of care immunotherapy)
Kidney Cancer Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT05327686 — Phase 2
Avelumab (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327686 — Phase 2
~132 spots leftby Jun 2028