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Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers

Metastatic Malignant Neoplasm in the Bone Clinical Trial

Official title:
Dual Immune Checkpoint Blockade and Hypofractionated Radiation in Patients With Salivary Gland Cancers

Clinical Trial Summary

This phase I/II trial studies the side effects and how well nivolumab and ipilimumab works when given together with stereotactic body radiation therapy (SBRT) in treating patients with salivary gland cancers. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving nivolumab and ipilimumab and SBRT may work better in treating patients with advanced salivary gland cancers.

Clinical Trial Description

Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity. After completion of study treatment patients are followed up at 30 days and then every 8 or 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03749460
Study type Interventional
Source University of Washington
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 15, 2019
Completion date November 5, 2023
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