Phase 2 Completed N=9 Treatment

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

Source: ClinicalTrials.gov NCT02759575 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Mar 2021

Primary outcomePrimary: Number of Participants With Treatment-Related Grade 3 or 4 Adverse Events as Assessed by CTCAE V4.0 — 2 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Related Grade 3 or 4 Adverse Events as Assessed by CTCAE V4.0	2	—
PRIMARY Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma	9	—
SECONDARY Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma	9	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02759575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.