Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

Key facts

Study ID

NCT02952586

Run by

Pfizer

People needed

697

Starts

2016-11-28

Expected to finish

2020-08-25

Last updated by the study team

2021-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
• HPV negative disease, Stage III, IVa, IVb; non-oropharyngeal HPV positive disease Stage III, IVa, IVb, HPV positive oropharyngeal disease T4 or N2c or N3
• No prior therapy for advanced stage SCCHN; eligible for definitive CRT with curative intent.
• Available tumor samples for submission or willing to undergo further tumor biopsies:
• Age ≥18 years (≥19 in Korea;20 years in Japan and Taiwan).
• ECOG Performance Status 0 or 1
• Adequate bone marrow function
• Adequate renal function
• Adequate liver function
• Pregnancy test (for patients of childbearing potential) negative at screening

You may not qualify if…

• Prior immunotherapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways.
• Major surgery 4 weeks prior to randomization.
• Prior malignancy requiring tumor-directed therapy within the last 2 years prior to enrollment, or concurrent malignancy associated with clinical instability. Exceptions for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, prostate cancer (Gleason score 6) either curatively treated or deemed to not require treatment, ductal IS carcinoma of the breast that has completed curative treatment, adequately treated basal cell or squamous cell skin cancer.
• Active autoimmune disease
• Any of the following in the 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.
• Active infection requiring systemic therapy.
• Use of immunosuppressive medication at time of randomization
• Prior organ transplantation including allogenic stem-cell transplantation.
• Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
• Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Vaccination within 4 weeks prior to randomization.
• Current use of or anticipated need for treatment with other anti-cancer drugs.
• Pregnant female patients, breastfeeding female patients, and male patients able to father children and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study and for at least 6 months after the last dose of cisplatin and 60 days after the last dose of avelumab/placebo (whichever is later).

Where it is running

• Highlands Oncology Group — Rogers, Arkansas, United States
• Highlands Oncology Group — Springdale, Arkansas, United States
• The Oncology Institute of Hope and Innovation — Anaheim, California, United States
• CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Beverly Hills Cancer Center — Beverly Hills, California, United States
• Tower Hematology Oncology Medical Group — Beverly Hills, California, United States
• UCSD Radiation Oncology South Bay, Cancer Treatment Centers — Chula Vista, California, United States
• City of Hope Corona — Corona, California, United States
• Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc. — Corona, California, United States
• The Oncology Institute of Hope and Innovation — Downey, California, United States
• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
• The Oncology Institute of Hope and Innovation — Glendale, California, United States
• UC San Diego Medical Center- La Jolla (Thornton Hospital) — La Jolla, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• City of Hope Antelope Valley — Lancaster, California, United States
• The Oncology Institute of Hope and Innovation — Long Beach, California, United States
• The Oncology Institute of Hope and Innovation — Los Angeles, California, United States
• Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• The Oncology Institute of Hope and Innovation — Lynwood, California, United States
• The Oncology Institute of Hope and Innovation — Montebello, California, United States
• UC Irvine Medical Center — Orange, California, United States
• Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc. — Riverside, California, United States
• UC San Diego Medical Center- Hillcrest — San Diego, California, United States
• The Oncology Institute of Hope and Innovation — Santa Ana, California, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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