A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma
Completed · Phase 1/Phase 2
Conditions studied: Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT02759575
- Run by
- Vinita Takiar
- People needed
- 9
- Starts
- 2016-04-01
- Expected to finish
- 2021-02-01
- Last updated by the study team
- 2021-03-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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