Stereotactic Radiation and Immunotherapy for Kidney Cancer

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial

Recruiting Phase 2 Interventional Study
Metastatic Renal Cell Carcinoma Stage III Renal Cell Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8 Unresectable Renal Cell Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
240 (estimated)
Sponsor
NRG Oncology · Other
Who this trial is looking for

This trial is looking for patients with kidney cancer that cannot be surgically removed and has spread to other parts of the body. Participants will receive a combination of precise radiation treatment and immune therapy to help manage their cancer.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with kidney cancer confirmed by a doctor.
  • I have measurable cancer that is either node-positive or metastatic.
  • I have cancer that is not recommended for surgery.
  • I am ages 18 or older.
  • I have a good performance status and can carry out daily activities.
  • I agree to use effective birth control while in the trial.
  • I have certain blood test results that show I am healthy enough for the trial.

You may not be able to join if

  • I have planned definitive treatment for all my metastatic disease.
  • I have untreated or unstable brain metastases.
  • I have had radiation therapy to my kidney that overlaps with the treatment area.
  • I have received any systemic therapy for kidney cancer within the last 90 days.
  • I have severe active autoimmune disease requiring treatment.
  • I have had severe allergic reactions to certain antibodies.
  • I have uncontrolled high blood pressure.
  • I am currently undergoing major surgery.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread from where it first started (primary site) to other places in the body (metastatic). Radiation…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma prior to registration * Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following diagnostic workup: * History/physical examination within 45 days prior to regi…
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