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Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02769520
Recruitment Status : Recruiting
First Posted : May 11, 2016
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ezra Cohen, University of California, San Diego

Brief Summary:
The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and neck remains disease-free following locoregional disease recurrence.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: Pembrolizumab Phase 2

Detailed Description:
This is a prospective, multi-center, open label, phase II study with a window of opportunity component in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) treated with adjuvant pembrolizumab following salvage surgery. Forty-five (45) patients will participate in this study to determine disease-free survival probability at 12 months. Secondary objectives include assessments of disease-free survival probability at 2 years, overall survival, adverse events and toxicity, and immune and molecular correlatives. For the window of opportunity component, patients will be randomized 3:1 in favor of receiving pembrolizumab 200 mg administered intravenously (IV) every three weeks for a maximum of two doses, versus placebo prior to salvage surgery. Approximately three to six weeks following the first dose of pembrolizumab, patients will undergo salvage surgery. Tumor tissue and blood will be collected at the time of surgery for immune correlative studies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 2 Efficacy Study With Window of Opportunity Immune Assessment of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Actual Study Start Date : July 6, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab
Pembrolizumab 200 mg will be administered by IV infusion every 3 weeks up to 12 months or until disease progression
Drug: Pembrolizumab
200 mg will be administered by IV infusion every 3 weeks up to 12 months or until disease progression




Primary Outcome Measures :
  1. Disease-Free Survival [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Disease-Free Survival at 2 years [ Time Frame: 2 years ]
  2. Overall Survival [ Time Frame: 3 years ]
  3. Safety: Incidence of Adverse Events, Serious Adverse Events, and Treatment Delays [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has pathologically confirmed SCCHN (oral cavity, oropharynx, larynx, hypopharynx) with evidence of local and/or locoregional recurrence. Laryngeal tumors will only be included if there is evidence of extralaryngeal spread, or there is associated nodal disease. For all other sites, superficial tumors can only be included if there is associated nodal disease.
  • Has a documented disease-free interval (minimum 16 weeks) after initial curative intent therapy.
  • Candidate for salvage resection.
  • Able to provide tissue from diagnostic core biopsy of tumor lesion(s).
  • Patient has adequate organ function.
  • Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication.
  • Female patient of childbearing potential agrees to use adequate birth control.
  • Male patient with a partner of childbearing potential agrees to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Exclusion Criteria:

  • Patient has disease of nasopharyngeal carcinoma histology.
  • Patient has evidence of metastatic disease.
  • Patient is currently receiving or has received another investigational agent within 4 weeks prior to study Day 1.
  • Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.
  • Patient has a known history of active TB (Bacillus Tuberculosis).
  • Patient has received a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or baseline) from adverse events due to a previously administered agents.
  • Patient has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.
  • Patients who have had major surgery or have insufficient recovery from surgical-related trauma or wound healing within 14 days from study Day 1.
  • Patient has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Patient has an 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). Notes: (1) Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded. (2) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Patient has a known history of, or any evidence of active, non-infectious pneumonitis.
  • Patient receives chronic steroid use > 10 mg prednisone (or steroid equivalent) daily.
  • Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
  • Patient has received immunotherapy with inhibitors of PD-1 or PD-L1, or CTLA-4 blocking antibodies within 4 months prior to study Day 1.
  • Patient has known active Hepatitis B infection (defined as presence of HepB sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier (HIV 1/2 antibodies).
  • Patient has interstitial lung disease.
  • Patient is an appropriate candidate for adjuvant radiation after salvage therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769520


Contacts
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Contact: Gerald Henderson 858-822-5223 gehenderson@ucsd.edu
Contact: Elaine Eng e1eng@ucsd.edu

Locations
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United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Gerald Henderson       gehenderson@ucsd.edu   
Principal Investigator: Ezra Cohen, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Alain Algazi, MD       alain.algazi@ucsf.edu   
University of California Los Angeles Recruiting
Torrance, California, United States, 90505
Contact: Deborah Wong, MD    310-325-8252    dewong@mednet.ucla.edu   
Sponsors and Collaborators
Ezra Cohen
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Ezra Cohen, MD University of California, San Diego

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Responsible Party: Ezra Cohen, Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02769520    
Other Study ID Numbers: 151615
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ezra Cohen, University of California, San Diego:
squamous cell carcinoma head and neck
pembrolizumab
cancer
SCCHN
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents