Active — Not RecruitingPhase 2

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

United States69 participantsStarted 2018-10-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Subjects must have signed and dated an IRB approved written informed consent form in accordance with regulatory and institutional guidelines. * Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations. * Males and females ≥ 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * 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. * 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. * 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. * Patient must be eligible to continue to receive an immune checkpoint inhibitor after radiotherapy. * Subjects must have at least two lesions: * One lesion must be safely amenable to irradiation in the opinion of the treating radiation oncologist. This can be a…

What they're measuring

evaluate overall response rate (ORR)

Timeframe: 24 weeks

Trial details

NCT IDNCT03693014

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10