ACTIVE_NOT_RECRUITING

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Talk to us

Conditions

Head and Neck Squamous Cell CarcinomaCancerCancer of Head and NeckCancer, AdvancedCancer, MetastaticTumorTumor RecurrenceTumor NeckTumor MetastasisOral CancerOropharyngeal CancerOropharynx CancerOropharynx Cancer, Stage IIIOropharynx Cancer, RecurrentOropharynx Cancer, MetastaticHead and NeckPembrolizumabCisplatinRadiotherapyp16+immunotherapypd-1chemotherapyT1T2T3N2M0T4N3N1

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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)

Quick Facts

Study Start:2018-03-15
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03383094

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * p16-positive squamous cell carcinoma of the pharynx, larynx or oral cavity
  2. * High-Intermediate Risk Disease, defined as:
  3. * 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)
  4. * T1-2 N1-3 M0 or T3-4 N0-3 M0 (stage III-IVB) p16+ squamous cell carcinoma of the hypopharynx or larynx
  5. * T1-2 N2-3 M0 or T3-4 N0-3 M0 (stage III-IVB) p16+ squamous cell carcinoma of the nasopharynx
  6. * Inoperable T4 N0-3 M0 (stage IVA-IVB) p16+ squamous cell carcinoma of the oral cavity
  7. * Measurable disease based on RECIST 1.1
  8. * Adequate hematologic function within 28 days prior to registration
  9. * Adequate renal and hepatic function
  10. * Female subject of childbearing potential should have a negative pregnancy test
  11. * Female subjects of childbearing potential must agree to use an adequate method of contraception for the course of the study
  12. * Male subjects must agree to use an adequate method of contraception for the course of the study
  1. * Prior malignancy within the past 3 years (except non-melanomatous skin cancer and early stage treated prostate cancer);
  2. * Prior head and neck radiation, chemotherapy, or immunotherapy;
  3. * Prior oncologic (radical) surgery to the primary site;
  4. * Documented evidence of distant metastases;
  5. * Severe, active co-morbidity defined as follows:
  6. * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
  7. * Transmural myocardial infarction within the last 6 months;
  8. * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  9. * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
  10. * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  11. * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol.
  12. * Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment;
  13. * Psychiatric/social situations that would limit compliance with study requirements
  14. * Hypersensitivity to pembrolizumab or any of its excipients.
  15. * 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.
  16. * Known history of, or any evidence of active, non-infectious pneumonitis.
  17. * Active infection requiring systemic therapy.
  18. * 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.
  19. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  20. * Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  21. * Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
  22. * Has received a live vaccine within 30 days of planned start of study therapy.

Contacts and Locations

Principal Investigator

Loren Mell, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

University of Arizona Cancer Center
Tucson, Arizona, 85719
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
H. Lee Moffitt Cancer Center & Research Facility
Tampa, Florida, 33612
United States
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, 63110
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Loren Mell, MD

  • Loren Mell, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-03-15
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2018-03-15
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • cancer
  • Head and Neck
  • Pembrolizumab
  • Cisplatin
  • Radiotherapy
  • Head and Neck Squamous Cell Carcinoma
  • p16+
  • immunotherapy
  • pd-1
  • chemotherapy
  • T1
  • T2
  • T3
  • N2
  • M0
  • T4
  • N3
  • N1

Additional Relevant MeSH Terms

  • 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