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

Study acronym: SAMURAI
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Trial sites expanded: 328 → 348 locations
    • Secondary endpoints revised (9)
    • Study description expanded, about 11 words
  2. Eligibility criteria expanded, about 46 words
    • Secondary endpoints: details revised at 6 of 9 entries
    • Study description revised
    • Site details revised at 31 of 328 sites
  3. Study completion pushed from Jun 15, 2028 to Jun 15, 2033v16
  4. Trial sites expanded: 318 → 328 locationsv15
  5. Site details revised at 1 of 318 sitesv14
  6. Trial sites expanded: 313 → 318 locationsv13
  7. Study sites: 295 to 313v12
  8. Study sites: 258 to 295v11
  9. Study sites: 248 to 258v10
  10. Start date: Jun 30, 2022 to Feb 1, 2023v9 Show 7 more changesShow less
    • Study sites: 208 to 248
    • Study completion date: Jun 15, 2032 to Jun 15, 2028
    • Interventions: Avelumab (Biological), Axitinib (Drug), Cabozantinib (Drug), Ipilimumab (Biological), Lenvatinib (Drug), Nivolumab (Biological)… to Avelumab (Biological), Axitinib (Drug), Biospecimen Collection (Procedure), Bone Scan (Procedure), Cabozantinib (Drug), Computed Tomography…
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 5 of 9 entries
    • Study description expanded, about 59 words
    • Study title revised
  11. Study sites: 151 to 208v8
  12. Study sites: 104 to 151
    • Eligibility criteria expanded, about 9 words
    v7
  13. Study sites: 101 to 104v6
  14. Study sites: 86 to 101v5
  15. Study sites: 5 to 86v4
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Jul 15, 2022 to Jun 30, 2022
    v3
  17. Re-verified, no change to tracked fieldsv2
  18. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
NRG Oncology
67 trials monitored
See 5 trials at risk
Kidney Cancer
894 trials monitored
See 69 trials at risk
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 therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.
Trial Details
NCT Number NCT05327686
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Unresectable Renal Cell Carcinoma
Related terms Carcinoma, Renal Cell
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov