A Study of Several Radiation Doses for Patients With Progression on Immunotherapy/Checkpoint Inhibitors (NCT03693014)

🧪 Interventions in This Study

• Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Subjects must have signed and dated an IRB approved written informed consent form in accordance with regulatory and institutional guidelines.
2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations.
3. Males and females ≥ 18 years of age.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
5. Histologically confirmed metastatic cancer of any histology for which there is an FDA indication for an immune checkpoint inhibitor including melanoma, lung, bladder, renal and head/neck cancers.
6. Patient has been receiving treatment with an immune checkpoint inhibitor including but not limited to ipilimumab, nivolumab, avelumab, durvalumab, pembrolizumab, atezolizumab, and tremelimumab for at least 2 months. A combination of these therapies is also permitted. No max prior lines of therapy.
7. Patient has evidence of limited progression (up to 5 lesions either new or increase in at least 25% in the cross-sectional diameter of a known lesion) on most recent systemic imaging as determined by the treating physician. Patients with greater than 5 lesions can be included after discussion with the study investigators.
8. Patient must be eligible to continue to receive an immune checkpoint inhibitor after radiotherapy.
9. Subjects must have at least two lesions:
10. One lesion must be safely amenable to irradiation in the opinion of the treating radiation oncologist. This can be a lesion that was previously irradiated if it is deemed appropriate by the treating physician and principal investigator. Standard MSKCC re-irradiation dose constraints must be met.
11. At least one, not-to-be-irradiated lesion measurable by CT or MRI per RECIST 1.1 criteria.
12. Prior palliative or curative radiotherapy must be completed at least 14 days prior to treatment.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (10 Sites)

• Hartford Healthcare — Hartford, Connecticut
• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey
• Memorial Sloan Kettering Bergen — Montvale, New Jersey
• Memorial Sloan Kettering Commack — Commack, New York
• Memorial Sloan Kettering Westchester — Harrison, New York
• Memorial Sloan Kettering Cancer Center — New York, New York
• Memorial Sloan Kettering Rockville Centre — Rockville Centre, New York
• Memorial Sloan Kettering Nassau — Uniondale, New York
• Lehigh Valley Health Network — Allentown, Pennsylvania

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.