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Pembrolizumab + Radiation for Locally Adv SCC of the Head and Neck (SCCHN) Not Eligible Cisplatin

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609503
Recruitment Status : Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:
This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation, for locally advanced squamous cell carcinoma of the head and neck patients who are not good candidates for Cisplatin.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Pembrolizumab Radiation: Intensity Modulated Radiation Therapy Phase 2

Detailed Description:
This open label, phase II trial will enroll 29 subjects in order to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation for locally advanced squamous cell carcinoma head and neck patients who are not good candidates for Cisplatin. Objectives include estimating progression free survival and overall survival, response rates, safety and toxicity, and quality of life in these patients. Correlative studies, based on serial blood collections and tumor samples, may be done under a separate protocol based on availability of archival diagnostic tissue.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pembrolizumab and Radiation for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Not Eligible for Cisplatin Therapy
Actual Study Start Date : May 16, 2016
Actual Primary Completion Date : March 19, 2019
Estimated Study Completion Date : March 19, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open label
Pembrolizumab
Drug: Pembrolizumab
Pembrolizumab, 200 mg IV during cycle visits every 3-weeks for up to 6 cycles, or until toxicities are no longer tolerable
Other Name: Keytruda

Radiation
Intensity Modulated Radiation Therapy (IMRT)
Radiation: Intensity Modulated Radiation Therapy
Eligible participants will receive Intensity Modulated Radiation Therapy daily x 7 weeks
Other Name: IMRT




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 20 weeks ]
    The time from D1 of treatment to progression or death from any cause


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 20 weeks ]
    The time from Day 1 of treatment to death from any cause



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 to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be willing and able to provide written informed consent/assent for the trial
  • Be greater than or equal to 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1
  • Histologically or cytologically confirmed stage III-IV (non-metastatic) squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer. Nasopharyngeal cancer patients will be excluded.
  • Ineligible for high dose cisplatin therapy; the reason for ineligibility must be defined.
  • Demonstrate adequate organ function. All screening labs should be performed within 14 days of treatment initiation.
  • No prior curative attempts for this cancer (i.e., surgery, radiation and/or other).
  • Female patients of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. Serum pregnancy test may be required.
  • Female patients of childbearing potential should be willing 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.
  • Male patients should agree 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.
  • As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study.
  • Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment.

Exclusion Criteria:

  • If currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
  • 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 trial treatment.
  • Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent.
  • Has a known additional malignancy that is metastatic, progressing or requires active treatment.
  • Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease even if resolved; patients with vitiligo or resolved childhood asthma/atropy would be an exception to this rule.
  • Has clinical or radiologic evidence of interstitial lung disease or active, non-infectious pneumonitis
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has inadequate home environment or social support to safely complete the trial procedures.
  • 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-programmed cell death (PD-1), anti-PD-L1, anti-PD-L1, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
  • Has a known history of Human Immunodeficiency Virus (HIV) HIV 1/2 antibodies) Has 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 prior to the first dose of trial treatment.
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

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): NCT02609503


Locations
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United States, Maryland
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Jared Weiss, MD UNC Lineberger Comprehensive Cancer Center

Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02609503    
Other Study ID Numbers: LCCC 1509
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Pembrolizumab
Antineoplastic Agents
Antineoplastic Agents, Immunological