At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
CY +2 moredrug
Likely dose
CY 200 mg/m2from 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 2 Study of GVAX Colon Vaccine (With Cyclophosphamide) and Pembrolizumab in Patients With Mismatch Repair-Proficient (MMR-p) Advanced Colorectal Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Dec 5, 2016·Updated Feb 10, 2021
In Brief
A Phase 2 clinical trial evaluating CY, GVAX, and 1 other intervention for Metastatic Colorectal Cancer. Completed, enrolled 17 participants across 1 site.
Detailed Summary
This study will be looking at the objective response rate (ORR) as measured by RECIST in in patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated with CY/GVAX in combination with Pembrolizumab.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartMay 2017
Primary CompletionMar 2018
TodayJul 2026
First PostedDec 5, 2016
Enrollment StartMay 26, 2017
Primary CompletionMar 20, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.6 years ago
Interventions
CYdrug
CY is administered intravenously at 200 mg/m2
GVAXbiological
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting
Pembrolizumabdrug
Pembrolizumab is administered intravenously at 200 mg