CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
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/NCT02703714
NCT02703714Phase 2Completed
CompareCT.gov

Phase II Trial of Pembrolizumab (MK-3475) With GM-CSF Induction in Advanced Biliary Cancers

Robin Kate Kelley·interventional·Posted Mar 9, 2016·Updated Jan 25, 2022

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Sargramostim for Biliary Cancer. Completed, enrolled 42 participants across 1 site.

Detailed Summary

This is an open label phase II trial to examine efficacy and safety of a novel combination of pembrolizumab plus induction GM-CSF in patients with advanced biliary cancers treated at University of California, San Francisco (UCSF). This phase II study will examine the efficacy and safety of the novel combination of pembrolizumab plus induction GM-CSF in advanced biliary cancer patients with the hypotheses that the combination may increase proportion of patients with overall response compared to contemporary historical controls, with acceptable safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Cancer
CountriesUnited States
CollaboratorsAmerican Society of Clinical Oncology, Merck Sharp & Dohme LLC, National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 9, 2016
Enrollment StartMay 6, 2016
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.3 years ago

Interventions

Pembrolizumabdrug

200 mg given intravenously (IV)

Sargramostimdrug

250 µg given subcutaneously (SC)