CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 233 enrolled
Drug / intervention
Pembrolizumab +3 morebiological
Likely dose
Not stated in 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/NCT02611960
NCT02611960Phase 3Completed
CompareCT.gov

A Two-arm, Open-label, Randomized Phase III Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keynote-122)

Merck Sharp & Dohme LLC·interventional·Posted Nov 23, 2015·Updated Jul 13, 2023

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Capecitabine, and 2 other interventions for Nasopharyngeal Neoplasms. Completed, enrolled 233 participants.

Detailed Summary

This is a study of pembrolizumab (MK-3475) versus standard treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment. With Amendment 7 (effective 2-March-2022), upon study completion, participants will be discontinued and may be enrolled in an extension study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasopharyngeal Neoplasms
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 23, 2015
Enrollment StartApr 18, 2016
Primary CompletionNov 30, 2020
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 10.6 years ago

Interventions

Pembrolizumabbiological

IV infusion

Capecitabinedrug

oral tablet

Gemcitabinedrug

IV infusion

Docetaxeldrug

IV infusion