CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Pembrolizumab +2 moredrug
Likely dose
Pembrolizumab 200 mg intravenously every 3 weeks; Cisplatin 100 mg/m² intravenously every 3 weeks; Radiation therapy 70 Gy in 35 fractions over 7 weeksAI-extracted
Key inclusion· 5
  • Biopsy-proven, previously untreated stage III or IV squamous cell carcinoma of the larynx
  • Primary tumor stage T2 or T3 with any nodal stage (N0, N1, N2, N3)
  • Measurable disease by RECIST 1.1
  • ECOG performance status 0 or 1
Key exclusion· 5
  • T1 primary tumor
  • T4 large volume tumor causing laryngeal dysfunction at baseline (e.g., penetration into base of tongue with swallowing impairment)
  • Prior radiation therapy to the larynx or involved neck
  • Distant metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02759575
NCT02759575Phase 2Completed

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

Vinita Takiar·interventional·Posted May 3, 2016·Updated Mar 12, 2021

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab, Radiation Therapy, and 1 other intervention for Head and Neck Cancer. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 3, 2016
Enrollment StartApr 1, 2016
Primary CompletionJan 24, 2019
Study CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.2 years ago

Interventions

Pembrolizumabdrug

200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses

Radiation Therapyradiation

70 Gy in 35 fractions over 7 weeks

Cisplatindrug

100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.