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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

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)

Details

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.

Keywords

Squamous Cell Carcinoma of the Head and Neck squamous cell carcinoma head and neck pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Ability to understand and the willingness to sign a written informed consent.
  2. Patient 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.
  3. Patient has a documented disease-free interval (minimum 16 weeks) after initial curative intent therapy.
  4. Patient is a candidate for salvage resection.
  5. Patient is able to provide tissue from diagnostic core biopsy of tumor lesion(s).
  6. Patient has an ECOG Performance Status of 0-2.
  7. Patient has adequate organ function.
  8. Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication.
  9. Female patient of childbearing potential agrees to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.

Note: Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for> 1 year.

  1. 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.

You CAN'T join if...

  1. Patient has disease of nasopharyngeal carcinoma histology.
  2. Patient has evidence of metastatic disease.
  3. Patient is currently receiving or has received another investigational agent within 4 weeks prior to study Day 1.
  4. 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.
  5. Patient has a known history of active TB (Bacillus Tuberculosis).
  6. Hypersensitivity to any of the inactive ingredients (histidine, sucrose, polysorbate 80) or to other humanized monoclonal antibodies (mAbs).
  7. 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.
  8. Patient has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.
  9. Patient has not recovered (i.e., ≤ Grade 1 or baseline) from adverse events due to prior anticancer therapy. Note: Patients with ≤ Grade 2 neuropathy are eligible.
  10. Patient has had a prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE> Grade 1.
  11. Patients who have had major surgery or have insufficient recovery from surgical-related trauma or wound healing within 14 days from study Day 1.
  12. 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.
  13. 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.
  14. 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.
  15. Patient has a known history of, or any evidence of active, non-infectious pneumonitis.
  16. Patient has an active infection requiring systemic therapy.
  17. Patient receives chronic steroid use> 10 mg prednisone (or steroid equivalent)daily.
  18. Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  19. Patient has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  20. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
  21. 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.
  22. 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).
  23. Patient has received a live vaccine within 30 days of study Day 1. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  24. Patient has interstitial lung disease.

Additional Exclusion Criteria Specific for Initiating Adjuvant Pembrolizumab:

  1. Patient is an appropriate candidate for adjuvant radiation after salvage therapy.

Locations

  • University of California Los Angeles not yet accepting patients
    Torrance, California, 90505, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ezra Cohen
ID
NCT02769520
Phase
Phase 2
Study Type
Interventional
Last Updated
December 1, 2016
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