At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed RCC (histologic or cytologic)
- ✓Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) disease
- ✓IMDC intermediate (1-2 factors) or poor risk disease (≥3 factors)
- ✓Measurable disease (node positive or metastatic) by RECIST 1.1, excluding primary renal tumor
- ✕Planned definitive treatment of all metastatic sites rendering patient without extra-renal measurable disease
- ✕Untreated or unstable brain metastases or cranial epidural disease
- ✕Prior radiotherapy to kidney causing treatment field overlap
- ✕Systemic therapy for metastatic RCC initiated >90 days before registration
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)
In Brief
A Phase 2 clinical trial evaluating Avelumab, Axitinib, and 10 other interventions for Metastatic Renal Cell Carcinoma and 3 related conditions. Currently recruiting, targeting 240 participants across 328 sites in 4 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & 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. Patients also undergo CT scan or MRI throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial.
Patients undergo SABR on 3 different days over 1-3 weeks and receive immunotherapy as in Arm I. Patients also undergo CT scan or MRI throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial.
Interventions
Given IV
Given PO
Undergo collection of blood
Undergo bone scan
Given PO
Undergo CT
Given IV
Given PO
Undergo MRI
Given IV
Given IV
42 Gy in 3 fractions