Study on Different Radiation Doses for Patients Whose Cancer Progresses on Immunotherapy

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of metastatic cancer for which an immune checkpoint inhibitor is approved, such as melanoma, lung, bladder, kidney, or head/neck cancers.
• Currently receiving treatment with an immune checkpoint inhibitor like ipilimumab, nivolumab, or pembrolizumab for at least 2 months.
• Cancer has shown limited progression, with up to 5 new or growing lesions.
• Eligible to continue receiving an immune checkpoint inhibitor after radiation therapy.
• Have at least two cancer lesions:
  • One lesion must be suitable for radiation treatment.
  • At least one lesion must be measurable by CT or MRI and not be treated with radiation.
• Completed any prior radiation therapy at least 14 days before starting the study treatment.
• Must not be taking high doses of steroids or other immunosuppressive medications within 14 days before starting radiation therapy.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
• Men must use contraception if sexually active with women of childbearing potential.

Exclusion Criteria

• Have untreated or active brain metastases or leptomeningeal disease.
• Have any medical condition that could increase the risk of participating in the study or affect the results.
• Have had another active cancer within the past 3 years, except for certain low-risk cancers.
• Have an active autoimmune disease, except for conditions like vitiligo or type I diabetes.
• Require systemic treatment with high doses of steroids or other immunosuppressive medications within 14 days of starting the study.
• Have a history of severe allergic reactions to checkpoint inhibitors or monoclonal antibodies.
• Women must not be breastfeeding.