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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

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.

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.

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.

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.

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.

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

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

Ipilimumab

2015

Completed Phase 3

~3420

Cabozantinib

2020

Completed Phase 2

~2360