Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Tyler M. Seibert (ucsd)
Headshot of Tyler M. Seibert
Tyler M. Seibert

Description

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 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.

Official Title

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Details

Keywords

Metastatic Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Unresectable Renal Cell Carcinoma, Carcinoma, Renal Cell Carcinoma, Pembrolizumab, Nivolumab, Ipilimumab, Avelumab, Lenvatinib, Axitinib, Monoclonal Antibodies, Cabozantinib, Stereotactic Ablative Radiotherapy

Eligibility

Locations

Lead Scientist at University of California Health

  • Tyler M. Seibert (ucsd)
    Dr. Seibert is a clinical translational researcher working on imaging and genetics for cancer detection and treatment. More at SeibertLab.com.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NRG Oncology
ID
NCT05327686
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated