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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03521570
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • IMRT — RADIATION
    Undergo intensity-modulated radiation therapy
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jun 28, 2018
Status verified
Sep 2024
Primary completion
Jul 25, 2022
Completion
Sep 7, 2023

Study Design

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

Arms

  • Experimental: Treatment (nivolumab, IMRT)
    Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Progression-Free Survival (PFS) [ Time Frame: 1 year from study start ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Cleveland Clinic FoundationClevelandOhio44195-
Froedtert and the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Atlanta, GA

By research site
Emory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GACleveland Clinic Foundation· Cleveland, OHFroedtert and the Medical College of Wisconsin· Milwaukee, WI

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