NCT03693014

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

A Phase II Trial of Hypofractionated Radiotherapy in Patients With Limited Progression on Immune Checkpoint Blockade

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Cancer
• Melanoma Cancer
• Lung Cancer
• Bladder Cancer
• Renal Cancer
• Head/Neck Cancers

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiotherapy	(27 Gy over 3 fractions)
BIOLOGICAL	Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab	The checkpoint inhibitor that the patient was already receiving should be continued according to the standard schedule and dose of administration as determined by the treating physician. Immune Checkpoint Inhibitors include Ipilimumab (Melanoma) Nivolumab (Melanoma, Renal, NSCLC), Pembrolizumab (Melanoma, NSCLC), Atezolizumab (Bladder)

Timeline

• Start date: 2018-10-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2018-10-02
• Last updated: 2025-10-06

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study