CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Pembrolizumabdrug
Likely dose
Pembrolizumab 200 mgfrom 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/NCT02306850
NCT02306850Phase 2Completed

Phase 2B Single-site, Open-label, Nonrandomized Study Evaluating the Efficacy of Neoadjuvant Pembrolizumab for Unresectable Stage III and Unresectable Stage IV Melanoma

St. Louis University·interventional·Posted Dec 3, 2014·Updated Jun 20, 2019

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab for Unresectable Malignant Neoplasm and 4 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This study is being done to see if using the study drug, pembrolizumab, can shrink down melanoma tumors enough so that they will be small enough to cut out, so that there will be no cancer left in the body. Eligible participants include those who have not received any systemic melanoma therapies (i.e. participants do not have to fail ipilimumab or BRAF inhibitor) and those who have failed all available systemic options (if the participant meets other inclusion / exclusion criteria).

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 3, 2014
Enrollment StartJan 1, 2015
Primary CompletionJun 8, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.6 years ago

Interventions

Pembrolizumabdrug

At the Treatment Initiation Visit (Baseline/Day 1), subjects will begin treatment with IV pembrolizumab 200 mg infusions every 3 weeks. As in previous pembrolizumab trials, eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.