Radiation Therapy + Immunotherapy for Head and Neck Cancer

Recruiting at275 trial locations

Overseen by Loren K Mell

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Loren K Mell

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with advanced head and neck cancer who can't use cisplatin. They must have untreated, unresected squamous cell carcinoma in specific regions (larynx, hypopharynx, oropharynx, oral cavity) and meet health criteria like blood counts and organ function tests. Pregnant women are excluded, as are those with recent cancers (except certain skin/prostate cancers), severe illnesses or allergies to the drugs tested.

Inclusion Criteria

I am not pregnant and meet the criteria for being post-menopausal if applicable.

I have advanced cancer in my head or neck area.

I have submitted tissue samples for review and analysis to UCSF.

Exclusion Criteria

I haven't had cancer (except skin or early prostate cancer) in the last 3 years.

I need help with my personal care and cannot do any physical work.

My body weight is 30 kg or less.

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• Durvalumab (Monoclonal Antibodies)
• Intensity-Modulated Radiation Therapy (Radiation)

Trial Overview The study compares radiation therapy combined with durvalumab (an immunotherapy drug) versus cetuximab (another type of monoclonal antibody). It aims to see which combination works better for shrinking tumors in patients who cannot take cisplatin.

Participant Groups

Group I: Arm II (durvalumab, radiation therapy) Experimental Treatment 5 Interventions

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.

Group II: Arm I (cetuximab, radiation therapy) Active Control 5 Interventions

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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+

Dr. Janet Dancey

Canadian Cancer Trials Group

Chief Medical Officer since 2014

MD, FRCPC

Susan Marlin

Canadian Cancer Trials Group

Chief Executive Officer since 2012

BSc (Hons) from Dalhousie University, MSc in Community Health and Epidemiology from Queen’s University

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School