SBRT + Checkpoint Inhibitors for Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must stop taking immunosuppressive medications like steroids at least 14 days before starting the trial. You can continue taking immune checkpoint inhibitors if you are already on them.
What data supports the effectiveness of the treatment SBRT + Checkpoint Inhibitors for Cancer?
Research shows that combining stereotactic ablative radiotherapy (SABR) with immunotherapy can improve survival rates in certain types of lung cancer and metastatic diseases. SABR is effective in controlling tumors locally, and when combined with immunotherapy, it may enhance outcomes by reducing recurrence and improving overall survival.12345
Is the combination of SBRT and checkpoint inhibitors generally safe for humans?
Stereotactic ablative radiotherapy (SABR), a form of SBRT, has been used safely in treating various cancers, but some serious complications have been reported. Strategies to reduce these risks are important, and SABR has shown minimal toxicity in certain cases, like skull base tumors. However, concerns about high-grade toxic effects exist, especially when treating multiple metastases.678910
How is the SBRT + Checkpoint Inhibitors treatment different from other cancer treatments?
SBRT combined with checkpoint inhibitors is unique because it uses precise, high-dose radiation to target tumors while simultaneously boosting the immune system's ability to fight cancer through drugs that block proteins like PD-1 and CTLA-4. This combination aims to enhance the body's immune response to cancer, potentially improving outcomes compared to using either treatment alone.1112131415
What is the purpose of this trial?
Drugs called checkpoint inhibitors help the immune system fight cancer. When the effectiveness of these drugs wears off, it may be possible to renew their effectiveness by combining it with a special type of radiation therapy called stereotactic body radiation therapy (SBRT). SBRT is a commonly used type of radiation therapy that gives high dose radiation with high precision to tumors in 1-5 treatments. Radiation therapy, such as SBRT can also treat sites of metastases. The use of checkpoint inhibitors in combination with SBRT has been suggested to improve the immune response against cancer but has not been tested in a formal clinical trial. Up to three lesions can be treated with SBRT. This study only allows checkpoint inhibitors that are already approved by the Federal Drug Agency (FDA) for the treatment of your disease. All radiation therapy will be done on machines which are FDA approved.
Research Team
Yoshiya Yamada, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
Adults with certain metastatic cancers (like melanoma, lung, bladder, renal, head/neck) who've been on approved checkpoint inhibitors for at least 2 months can join. They must have up to 5 progressing lesions and be able to continue immunotherapy post-radiation. Exclusions include active brain metastases, recent other treatments or severe allergies to monoclonal antibodies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive stereotactic body radiation therapy (SBRT) to 1-3 lesions over 3 fractions
Treatment
Participants continue treatment with checkpoint inhibitors until progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atezolizumab
- Ipilimumab
- Nivolumab
- Pembrolizumab
- Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy is already approved in European Union, United States, Canada, Japan for the following indications:
- Lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
- Early-stage lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
- Lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
- Lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor