Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

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Brief Title

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

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)

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).
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

progression-free survival (PFS)

Secondary Outcome

 overall survival

Condition

Head and Neck Squamous Cell Carcinoma

Intervention

Pembrolizumab

Study Arms / Comparison Groups

 Control-radiotherapy/cisplatin
Description:  Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent cisplatin 100 mg/m2 every 3 weeks for 3 cycles (7 weeks)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

114

Start Date

March 15, 2018

Completion Date

June 2024

Primary Completion Date

April 2021

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Loren Mell, MD, (858) 246-0471, [email protected]d.edu

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03383094

Organization ID

170862


Responsible Party

Sponsor-Investigator

Study Sponsor

Loren Mell, MD

Collaborators

 Merck Sharp & Dohme Corp.

Study Sponsor

Loren Mell, MD, Principal Investigator, University of California, San Diego


Verification Date

February 2021