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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT03749460
Phase
PHASE1/PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Given IV
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT

Study Details

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.

Key Dates

Start date
Jan 15, 2019
Status verified
Dec 2023
Primary completion
Nov 5, 2022
Completion
Nov 5, 2023

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab, ipilimumab, SBRT)
    Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an 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.

Primary Outcome Measure

Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 [ Time Frame: From start of treatment through up to 100 days after the completion of study treatment (up to 16 months total) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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