Nivolumab, Ipilimumab, and Radiation Therapy in Treating Patients With Stage III-IVB Head and Neck Cancer

Conditions

• Larynx
• Lip, Oral Cavity and Pharynx

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
  Given IV
• Ipilimumab — BIOLOGICAL
  Given IV
• Simultaneous-Integrated Boost Intensity-Modulated Radiation Therapy — RADIATION
  Undergo simultaneous integrated boost integrated modulated radiation therapy
• Volume Modulated Arc Therapy — RADIATION
  Undergo volumetric modulated arc therapy

Study Details

This pilot clinical trial studies the side effects of nivolumab, ipilimumab and radiation therapy in treating patients with stage IVA-B head and neck cancer. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may work better in treating patients with stage IVA-B head and neck cancer.

Key Dates

Start date

May 11, 2017

Status verified

Apr 2025

Primary completion

Sep 27, 2020

Completion

Nov 16, 2022

Study Design

Enrollment

24 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment ( nivolumab, ipilimumab, radiation therapy)
  Patients receive nivolumab IV over at least 30 minutes every 2 weeks and ipilimumab IV over at least 90 minutes every 6 weeks. Beginning week 3, patients undergo simultaneous integrated boost intensity modulated radiation therapy or volumetric modulated arc therapy for 5 days per week over 7 weeks. Patients continue nivolumab every 2 weeks for 12 doses and ipilimumab every 6 weeks for 4 doses. Courses repeat for up to 23 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events assessed using Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 6 months ]

Locations (1)

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