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ACTIVE NOT RECRUITING
NCT03693014
PHASE2

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

69

Start Date

2018-10-01

Completion Date

2026-10

Last Updated

2025-10-06

Healthy Volunteers

No

Interventions

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)

Locations (10)

Hartford Healthcare

Hartford, Connecticut, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States