Study on Stereotactic Body Radiation Therapy for Limited Progression in Metastatic Kidney Cancer Patients on Immune Checkpoint Inhibitors

Sponsor: Yale University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04974671

Provider View

This clinical trial is exploring whether targeted radiation therapy can help control cancer in patients with metastatic kidney cancer who are already receiving immune checkpoint inhibitors. The study focuses on patients whose cancer has shown limited progression in a few areas.

Patient Parameters

Program Overview

The purpose of this Phase II study is to see if using Stereotactic Body Radiation Therapy (SBRT) on up to five cancer spots that have shown limited progression can help patients with metastatic kidney cancer who are on immune checkpoint inhibitors. Patients must have received their last dose of systemic therapy within three months before joining the trial. The study will also allow other local treatments like surgery or radiofrequency ablation on some of the cancer spots, as long as at least one spot receives SBRT. The radiation will be given on non-consecutive days, and the number of sessions will depend on the location of the cancer. Patients will continue their current immune checkpoint inhibitor treatment during and after the radiation therapy until their cancer progresses further. The study will monitor the response to treatment and any side effects.

Description

This study is testing whether adding Stereotactic Body Radiation Therapy (SBRT) to the treatment plan of patients with metastatic kidney cancer can help control the disease when it has shown limited progression in a few areas. Patients will continue their current immune checkpoint inhibitor treatment while receiving SBRT. The radiation therapy will be given in 1-5 sessions, depending on the location of the cancer, and can be done on different days. Other local treatments like surgery or radiofrequency ablation are allowed for some cancer spots, but at least one must receive SBRT. The study will track how well the cancer responds to the treatment and any side effects. Patients will have regular imaging tests to assess the cancer's response, and the treatment plan will be discussed by a team of cancer specialists before starting.

Eligibility Criteria

Inclusion Criteria

  • Be willing and able to provide written consent to participate.
  • Be 18 years or older.
  • Have confirmed kidney cancer that has spread to other parts of the body, as seen on imaging tests.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Have a life expectancy of more than 6 months.
  • Have been on an immune checkpoint inhibitor treatment for at least 3 months before the cancer showed limited progression, with the last dose received within 3 months of joining the trial.
  • Have limited progression in up to 5 cancer spots, with no previous local treatment to those areas.
  • Have adequate organ function based on recent lab tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and use effective birth control during the study.
  • Men must agree to use contraception during the study and for 6 months after the last dose of treatment.

Exclusion Criteria

  • Have had radiation therapy within 2 weeks before starting the study treatment.
  • Are receiving a tyrosine kinase inhibitor (TKI) as part of their current treatment.
  • Have cancer progression only in the brain.
  • Have a diagnosis of immunodeficiency or are on immunosuppressive therapy within 2 weeks before starting the study treatment.
  • Have another active cancer that requires treatment, except for certain skin cancers or cervical cancer that has been treated.
  • Have an active autoimmune disease requiring treatment within the past 3 months.
  • Have a history of lung inflammation that required steroids or current lung disease.
  • Have an active infection requiring treatment.
  • Are pregnant or breastfeeding, or planning to conceive or father children during the study and for 120 days after the last treatment.
  • Have active Hepatitis B or C.
  • Have received a live vaccine within 30 days before starting the study treatment.
  • Have medical conditions that prevent safe radiation therapy, such as certain lung or connective tissue diseases.

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