CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Docetaxel +1 moredrug
Likely dose
Docetaxel 75mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02718820
NCT02718820Phase 2Completed

Immunomodulation of Pembrolizumab Plus Docetaxel for the Treatment of Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (HNSCC) After Platinum Failure

Medical University of Vienna·interventional·Posted Mar 24, 2016·Updated Jan 9, 2024

In Brief

A Phase 2 clinical trial evaluating Docetaxel and Pembrolizumab for Head and Neck Carcinoma. Completed, enrolled 22 participants across 1 site.

Detailed Summary

Squamous cell carcinoma of the head and neck, which accounts for 90% of head and neck cancers, is the tenth most common cancer worldwide with over 650000 new cases per year. The major risk factors for HNSCC development comprise alcohol and tobacco consumption. During the last decades human papilloma virus infection (HPV) has been identified to contribute to the development of oropharyngeal HNSCC in a subgroup of patients5. Standard treatment options include surgery, (chemo)radiation and chemotherapy. Despite improvements of treatment regimens the recurrence rate of stage III/IV disease after curative therapy is about 30-40%. In locoregionally unresectable recurrent or metastatic disease palliative poly-chemotherapy is the mainstay of therapy.The median survival time of these patients is 6-8 months. Based on the results of the EXTREME study a combination regimen containing a platinum drug, 5 fluorouracil (5-FU) and weekly cetuximab has become standard of care in this setting. For patients, who progressed after platinum based therapy, treatment options are scarce. Besides platinum drugs, taxanes such as paclitaxel or docetaxel were shown to be of particular use in this setting. Apart from that there has been increasing preclinical and clinical evidence that immune-checkpoint inhibitors such as pembrolizumab might play a role in HNSCC. Thus, it is the aim of this study to test if the combination of docetaxel and pembrolizumab after platinum failure is an effective and safe regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 24, 2016
Enrollment StartMar 1, 2016
Primary CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 10.3 years ago

Interventions

Docetaxeldrug

Docetaxel 75mg/m2; q21

Pembrolizumabdrug

Pembrolizumab 200mg, q21