RecruitingPhase 2

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

United States240 participantsStarted 2023-02-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 registration * CT/magnetic resonance imaging (MRI) of the chest/abdomen/pelvis within 45 days prior to registration * Patients must have IMDC intermediate (1-2 factors) or poor risk disease (\>= 3 factors) * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor * Patient not recommended for or refused immediate cytoreductive nephrectomy * Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen * Primary renal tumor measuring 20 cm or less in anterior to posterior dimension only on axial imaging * Age \>= 18 * Karnofsky performance status \>= 60 within 45 days prior to registration * Hemoglobin \>= 8 g/dL (transfusions are allowed) (within 45 days prior to registration) * Platelet count \>= 50,000/mm\^3 (within 45 days prior to registration) * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within 45 days prior to registration) * Calculated (…

What they're measuring

Nephrectomy and radiographic progression-free survival (nrPFS)

Timeframe: From randomization to last follow-up, up to 8 years

Trial details

NCT IDNCT05327686

SponsorNRG Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-15