At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
Imprime PGG +2 moredrug
Likely dose
Imprime PGG 2mg/kgfrom 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.
A Phase Ib/II Study of Anti-PD-1 Antibody Pembrolizumab and Imprime PGG for Patients With Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017
In Brief
A Phase 2 clinical trial evaluating Imprime PGG and MK-3475 for Non-Small Cell Lung Cancer. Completed, enrolled 35 participants across 5 sites.
Detailed Summary
This is an open label, multi-institutional, single arm study with a dose escalation phase Ib cohort, followed by a phase II cohort of pembrolizumab and Imprime PGG. No randomization or blinding is involved.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, HiberCell, Inc.
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartJul 2017
Primary CompletionNov 2021
Study CompletionNov 2022
TodayJul 2026
First PostedDec 28, 2016
Enrollment StartJul 11, 2017
Primary CompletionNov 22, 2021
Study CompletionNov 28, 2022
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 9.5 years ago
Interventions
Imprime PGGdrug
Arm A: Phase Ib Cohort 1: 2mg/kg IV; Arm A: Phase Ib Cohort 2: 4mg/kg IV
MK-3475drug
200mg IV
Imprime PGGdrug
Arm B: Phase II treatment: administered at the maximum safe dose of 2mg or 4 mg as established in the Phase Ib cohort study.