Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin

Conditions

• Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Head and Neck Squamous Cell Carcinoma
• Hypopharyngeal Squamous Cell Carcinoma
• Laryngeal Squamous Cell Carcinoma
• Oral Cavity Squamous Cell Carcinoma
• Oropharyngeal Squamous Cell Carcinoma
• Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Squamous Cell Carcinoma of Unknown Primary
• Stage III Hypopharyngeal Carcinoma AJCC v8
• Stage III Laryngeal Cancer AJCC v8
• Stage III Lip and Oral Cavity Cancer AJCC v8
• Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage IVA Hypopharyngeal Carcinoma AJCC v8
• Stage IVA Laryngeal Cancer AJCC v8
• Stage IVA Lip and Oral Cavity Cancer AJCC v8
• Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage IVB Hypopharyngeal Carcinoma AJCC v8
• Stage IVB Laryngeal Cancer AJCC v8
• Stage IVB Lip and Oral Cavity Cancer AJCC v8
• Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cetuximab — BIOLOGICAL
  Given IV
• Durvalumab — BIOLOGICAL
  Given IV
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo IMRT
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

This phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will work better than the usual therapy of radiation therapy with cetuximab in treating patients with head and neck cancer.

Key Dates

Start date

Apr 3, 2018

Status verified

May 2026

Primary completion

Sep 20, 2022

Completion

Sep 4, 2025

Study Design

Enrollment

196 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (cetuximab, radiation therapy)
  Patients receive cetuximab IV weekly over 60-120 minutes. Treatment repeats every week for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Beginning 5-7 days after first cetuximab dose, patients undergo IMRT 5 fractions per week for up to 7 weeks.
• Experimental: Arm II (durvalumab, radiation therapy)
  Patients receive durvalumab IV over 60 minutes every 4 weeks. Treatment repeats every 4 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients undergo IMRT 5 fractions per week for up to 7 weeks.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicity (DLT) [Lead-in Phase] [ Time Frame: From start of durvalumab to 4 weeks after radiation therapy, approximately 13 weeks. Weekly during RT, at RT end, prior to adjuvant durvalumab, one month after end of RT. ]

Locations (252)

Find similar trials in Birmingham, AL

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