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

• Status: Completed
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nooshin Hashemi-Sadraei; Vinita Takiar
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cisplatin; Pembrolizumab

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