Head and Neck Cancer Clinical Trial
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
Verified date | March 2021 |
Source | University of Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | February 2021 |
Est. primary completion date | January 24, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Vinita Takiar | Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Treatment-Related Grade 3 or 4 Adverse Events as Assessed by CTCAE V4.0 | 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 | 30 days following completion of treatment for the first 6 participants | |
Primary | Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma | This is the number of subjects that are laryngectomy-free at 18 months. | 18 months | |
Secondary | Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma | This is the number of subjects that are laryngectomy-free at 12 months. | 12 months |
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