NCT03749460

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Malignant Neoplasm in the Bone
• Metastatic Malignant Neoplasm in the Lung
• Salivary Gland Carcinoma
• Stage IV Major Salivary Gland Cancer AJCC v8
• Stage IVA Major Salivary Gland Cancer AJCC v8
• Stage IVB Major Salivary Gland Cancer AJCC v8
• Stage IVC Major Salivary Gland Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Given IV
BIOLOGICAL	Ipilimumab	Given IV
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2019-01-15
• Primary completion: 2022-11-05
• Completion: 2023-11-05
• First posted: 2018-11-21
• Last updated: 2023-12-29
• Results posted: 2023-12-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study