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NCT03383094 | RECRUITING | Head and Neck Squamous Cell Carcinoma

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer
Sponsor:

Loren Mell, MD

Information provided by (Responsible Party):

Loren Mell, MD

Brief Summary:

The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

Condition or disease

Head and Neck Squamous Cell Carcinoma

Cancer

Cancer of Head and Neck

Cancer, Advanced

Cancer, Metastatic

Tumor

Tumor Recurrence

Tumor Neck

Tumor Metastasis

Oral Cancer

Oropharyngeal Cancer

Oropharynx Cancer

Oropharynx Cancer, Stage III

Oropharynx Cancer, Recurrent

Oropharynx Cancer, Metastatic

Intervention/treatment

Pembrolizumab

Radiation therapy

Cisplatin

Phase

PHASE2

Detailed Description:

This study is a prospective, multi-institutional, open-label, randomized phase II trial that will evaluate the efficacy of concurrent and adjuvant pembrolizumab with radiation therapy (RT) versus RT plus cisplatin in intermediate/high-riskp16-positive locoregionally advanced head and neck squamous cell carcinoma (HNSCC). The primary endpoint is progression-free survival (PFS).

Study Type : INTERVENTIONAL
Estimated Enrollment : 114 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase II Randomized Trial of Radiotherapy With Concurrent and Adjuvant Pembrolizumab (Keytruda®) Versus Concurrent Chemotherapy in Patients With Advanced/Intermediate-Risk p16+ Head and Neck Squamous Cell Carcinoma (KEYCHAIN)
Actual Study Start Date : 2018-03-15
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * p16-positive squamous cell carcinoma of the pharynx, larynx or oral cavity
  • * High-Intermediate Risk Disease, defined as
    • * T1-T3 N2 M0 or T3 N1 M0 or any stage III (T4 or N3) p16+ squamous cell carcinoma of the oropharynx (AJCC 8th edition staging system)
    • * T1-2 N1-3 M0 or T3-4 N0-3 M0 (stage III-IVB) p16+ squamous cell carcinoma of the hypopharynx or larynx
    • * T1-2 N2-3 M0 or T3-4 N0-3 M0 (stage III-IVB) p16+ squamous cell carcinoma of the nasopharynx
    • * Inoperable T4 N0-3 M0 (stage IVA-IVB) p16+ squamous cell carcinoma of the oral cavity
    • * Measurable disease based on RECIST 1.1
    • * Adequate hematologic function within 28 days prior to registration
    • * Adequate renal and hepatic function
    • * Female subject of childbearing potential should have a negative pregnancy test
    • * Female subjects of childbearing potential must agree to use an adequate method of contraception for the course of the study
    • * Male subjects must agree to use an adequate method of contraception for the course of the study
    Exclusion Criteria
    • * Prior malignancy within the past 3 years (except non-melanomatous skin cancer and early stage treated prostate cancer);
    • * Prior head and neck radiation, chemotherapy, or immunotherapy;
    • * Prior oncologic (radical) surgery to the primary site;
    • * Documented evidence of distant metastases;
    • * Severe, active co-morbidity defined as follows
      • * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
      • * Transmural myocardial infarction within the last 6 months;
      • * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
      • * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
      • * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
      • * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol.
      • * Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment;
      • * Psychiatric/social situations that would limit compliance with study requirements
      • * Hypersensitivity to pembrolizumab or any of its excipients.
      • * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
      • * Known history of, or any evidence of active, non-infectious pneumonitis.
      • * Active infection requiring systemic therapy.
      • * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
      • * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
      • * Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
      • * Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
      • * Has received a live vaccine within 30 days of planned start of study therapy.
Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Location Details

NCT03383094

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

University of Arizona Cancer Center

Tucson, Arizona, United States, 85719

RECRUITING

United States, California

UC San Diego Moores Cancer Center

THE JOLLA, California, United States, 92093

RECRUITING

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 06520

RECRUITING

United States, Florida

H. Lee Moffitt Cancer Center & Research Facility

Tampa, Florida, United States, 33612

RECRUITING

United States, Missouri

Washington University School of Medicine, Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, Ohio

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

RECRUITING

United States, Tennessee

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37203