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Trial record 12 of 20 for:    15-02

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

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ClinicalTrials.gov Identifier: NCT02759575
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
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
Study Start Date : April 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

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.




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 ]

Secondary Outcome Measures :
  1. Laryngectomy-free survival in locally advanced laryngeal squamous cell carcinoma [ Time Frame: 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


Contacts
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Contact: UC Cancer Institute Clinical Trials Office 513-584-7698 cancer@uchealth.com

Locations
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United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: UC Cancer Institute Clinical Trials Office    513-584-7698    cancer@uchealth.com   
Principal Investigator: Vinita Takiar, MD         
Sponsors and Collaborators
Vinita Takiar
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Vinita Takiar, MD University of Cincinnati

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Responsible Party: Vinita Takiar, Assistant Professor of Radiation Oncology, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02759575     History of Changes
Other Study ID Numbers: UCCI-HN-15-02
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Cisplatin
Pembrolizumab
Antineoplastic Agents
Antineoplastic Agents, Immunological