Clinical Trials /

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

NCT02759575

Description:

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.

Related Conditions:
  • Laryngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: UCCI-HN-15-02
  • NCT ID: NCT02759575

Conditions

  • Head and Neck Cancer

Interventions

DrugSynonymsArms
PembrolizumabKeytrudaPembrolizumab
CisplatinPembrolizumab

Purpose

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 cancer. The standard of care treatment will include chemotherapy and radiation for 7 weeks.

Trial Arms

NameTypeDescriptionInterventions
PembrolizumabExperimentalPembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
  • Pembrolizumab
  • Cisplatin

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Laryngectomy-free survival in locally advanced laryngeal squamous cell carcinoma
Time Frame:12 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Nooshin Hashemi-Sadraei

Last Updated

April 29, 2016