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

NCT03749460 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-29

Study results available
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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.

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

BIOLOGICAL

Nivolumab

Given IV

BIOLOGICAL

Ipilimumab

Given IV

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Sponsors & Collaborators

Principal Investigators

  • Cristina Rodriguez · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2022-11-05
Completion
2023-11-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03749460 on ClinicalTrials.gov