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Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer

NCT03521570 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-09-19

Study results available
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Summary

This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work together in treating patients with head and neck squamous cell cancer that has come back. Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill cancer cells and shrink tumors, thereby reducing the damage to nearby healthy tissue. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving intensity-modulated radiation therapy and nivolumab may work better at treating head and neck squamous cell cancer.

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

RADIATION

IMRT

Undergo intensity-modulated radiation therapy

BIOLOGICAL

Nivolumab

Given IV

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • The Cleveland Clinic

    collaborator OTHER

  • Medical College of Wisconsin

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Nabil F. Saba, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2022-07-25
Completion
2023-09-07
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 NCT03521570 on ClinicalTrials.gov