CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Talimogene Laherparepvec +1 moredrug
Likely dose
Talimogene Laherparepvec 8.0 mLfrom 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/NCT02626000
NCT02626000Phase 1Completed
CompareCT.gov

A Phase 1b/3 Multicenter, Randomized, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for the Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Amgen·interventional·Posted Dec 10, 2015·Updated Sep 8, 2021

In Brief

A Phase 1 clinical trial evaluating Talimogene Laherparepvec and Pembrolizumab for Carcinoma of the Head and Neck. Completed, enrolled 36 participants across 33 sites in 11 countries.

Detailed Summary

The primary objective of this study was to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma of the Head and Neck
CountriesAustralia, Austria, Belgium, Canada, France, Greece, Italy, Spain, Switzerland, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 10, 2015
Enrollment StartApr 6, 2016
Primary CompletionNov 2, 2017
Study CompletionAug 28, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.6 years ago

Interventions

Talimogene Laherparepvecdrug

The initial dose of talimogene laherparepvec is up to 8.0 mL of 10⁶ PFU/mL. Subsequent doses of talimogene laherparepvec are up to 8.0 mL of 10⁸ PFU/mL.

Pembrolizumabbiological

Administered as a 30-minute intravenous infusion at a dose of 200 mg Q3W