A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/28/2018 |
| Start Date: | April 2016 |
| End Date: | January 2020 |
| Contact: | UC Cancer Institute Clinical Trials Office |
| Email: | cancer@uchealth.com |
| Phone: | 513-584-7698 |
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
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.
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.
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
We found this trial at
1
site
234 Goodman Dr
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Vinita Takiar, MD
Phone: 513-584-7698
University of Cincinnati Medical Center Opening in 1823 as the country
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