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A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma

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: NCT02759575
Recruitment Status : Completed
First Posted : May 3, 2016
Results First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Vinita Takiar, University of Cincinnati

Brief Summary:
The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for larynx cancer. The standard of care treatment will include chemotherapy and radiation for 7 weeks.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Pembrolizumab Radiation: Radiation Therapy Drug: Cisplatin Phase 1 Phase 2

Detailed Description:

This study is an open label, single arm study which will enroll patients with locally advanced squamous cell carcinomas of the larynx. Positive tumor PDL1 expression by IHC will not be required for enrollment.

All patients with receive Pembrolizumab and cisplatin in combination with radiation. Pembrolizumab 200 mg flat dose given Q21 days will begin 3 weeks prior to initiation of chemoradiation and continued through the 21-day cycle until completion of chemoradiation. Cisplatin will be given 100 mg/m2 every 21 days during radiation as per standard of care.

Pembrolizumab has well defined toxicities as single agent and has non-overlapping mechanisms of action with cisplatin and radiation. The safety of these agents used in combination has not been previously described, therefore the study will begin with a safety run-in phase 1 followed by the phase II design. See statistical section for details.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Chemo Radiation Plus the Anti-Programmed Death-1 (Anti-PD-1) Antibody, Pembrolizumab (MK-3475) for Locally Advanced Laryngeal Squamous Cell Carcinoma
Actual Study Start Date : April 2016
Actual Primary Completion Date : January 24, 2019
Actual Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
Drug: Pembrolizumab
200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
Other Name: Keytruda

Radiation: Radiation Therapy
70 Gy in 35 fractions over 7 weeks

Drug: Cisplatin
100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
Other Name: Platinol




Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Grade 3 or 4 Adverse Events as Assessed by CTCAE V4.0 [ Time Frame: 30 days following completion of treatment for the first 6 participants ]
    Greater than 2 grade 3 or 4 adverse events that are definitely, probably or possibly related to the pembrolizumab in the first cohort of 6 participants

  2. Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma [ Time Frame: 18 months ]
    This is the number of subjects that are laryngectomy-free at 18 months.


Secondary Outcome Measures :
  1. Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma [ Time Frame: 12 months ]
    This is the number of subjects that are laryngectomy-free at 12 months.



Information from the National Library of Medicine

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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:

  • Biopsy-proven, previously untreated stage III or IV squamous cell carcinoma of the larynx, Primary tumor stage (T2, T3) and nodal stage (N0, N1, N2, N3).
  • Measurable disease based on RECIST 1.1.
  • Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
  • Anticipated survival minimum of 12 months.
  • Adequate labs

Exclusion Criteria:

  • Patients with T1 primary tumor or T4 large volume tumor that has resulted in larynx dysfunction at baseline (for example tumor largely penetrating into base of tongue and resulting in inability to swallow at baseline)
  • Prior radiation therapy to the larynx area or involved neck.
  • Distant metastasis
  • Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C

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): NCT02759575


Locations
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United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Vinita Takiar
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Vinita Takiar, MD University of Cincinnati
  Study Documents (Full-Text)

Documents provided by Vinita Takiar, University of Cincinnati:
Informed Consent Form  [PDF] March 22, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vinita Takiar, Assistant Professor of Radiation Oncology, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02759575    
Other Study ID Numbers: UCCI-HN-15-02
First Posted: May 3, 2016    Key Record Dates
Results First Posted: March 12, 2021
Last Update Posted: March 12, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Cisplatin
Pembrolizumab
Antineoplastic Agents
Antineoplastic Agents, Immunological