SBRT + Checkpoint Inhibitors for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether combining stereotactic body radiation therapy (SBRT) with checkpoint inhibitors can enhance the immune system's ability to fight cancer. Checkpoint inhibitors help the body's defenses attack cancer cells, but their effectiveness can diminish over time. The trial seeks to determine if SBRT can restore their efficacy, particularly for individuals with metastatic cancer. Those with certain types of metastatic cancer, such as melanoma or lung cancer, who have been on checkpoint inhibitor treatment for at least two months, may qualify. Participants should have up to five cancer spots with limited growth and be able to continue checkpoint inhibitor therapy after radiation. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that stereotactic body radiotherapy (SBRT) is generally safe and well-tolerated. Studies indicate that patients receiving SBRT for certain cancers have experienced good survival rates and manageable side effects. Specifically, one study found SBRT to be safe and effective for treating lung cancer, yielding positive results for patients.
Checkpoint inhibitors, already approved by the FDA for some cancer types, have passed safety checks for those uses. Although combining SBRT with checkpoint inhibitors is new in a formal trial, each treatment has demonstrated acceptable safety in previous studies.
Overall, both treatments have been well-received in other settings, suggesting they could be safe when used together. This will be confirmed in the trial.12345Why are researchers excited about this trial's treatments?
Stereotactic Body Radiotherapy (SBRT) combined with checkpoint inhibitors is unique because it offers a targeted approach that can precisely hit cancer cells while minimizing damage to surrounding healthy tissue. Unlike conventional radiation therapy, which can affect larger areas, SBRT delivers high doses of radiation to very specific spots, potentially leading to fewer side effects and quicker recovery times. Additionally, checkpoint inhibitors work by unleashing the body's immune system to fight cancer more effectively. Researchers are excited about this combination because it could enhance the immune response against tumors, offering a powerful one-two punch that could outperform existing treatments like chemotherapy and standard radiation therapy.
What evidence suggests that the combination of SBRT and checkpoint inhibitors could be effective for cancer?
Studies have shown that stereotactic body radiation therapy (SBRT) effectively treats cancer. For example, two years after SBRT treatment, survival rates range from 80% to 90%. This type of radiation precisely targets tumors, often leading to better results. In this trial, researchers will combine SBRT with checkpoint inhibitors, which help the immune system fight cancer. This combination could enhance the effectiveness of these drugs. Although clinical trials have not formally tested this specific combination, it appears promising based on the individual effectiveness of each treatment.13467
Who Is on the Research Team?
Yoshiya Yamada, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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