Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT02981524|
Recruitment Status : Completed
First Posted : December 5, 2016
Results First Posted : October 8, 2019
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: CY Biological: GVAX Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of GVAX Colon Vaccine (With Cyclophosphamide) and Pembrolizumab in Patients With Mismatch Repair-Proficient (MMR-p) Advanced Colorectal Cancer|
|Actual Study Start Date :||May 26, 2017|
|Actual Primary Completion Date :||March 20, 2018|
|Actual Study Completion Date :||March 20, 2018|
Experimental: CY/GVAX with Pembrolizumab
During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells for the first 4 cycles of treatment. After cycle 4, cyclophosphamide and GVAX will be administered with every 4th cycle.
CY is administered intravenously at 200 mg/m2
Other Name: Cyclophosphamide, Cytoxan
GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting
Other Name: Colon cancer vaccine
Pembrolizumab is administered intravenously at 200 mg
Other Name: KEYTRUDA, MK-3475
- Objective Response Rate (ORR) [ Time Frame: up to 1 year ]ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 1 year ]Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 4.0.
- Progression Free Survival (PFS) [ Time Frame: up to 1 year ]Progression-free Survival (PFS) is defined as the number of days from cycle 1, day 1 of immunotherapy until first documented local progression or death due to any cause. PD is >20% increase in sum of diameters of target lesions as assessed using RECIST (version 1.1).
- Overall Survival (OS) [ Time Frame: Up to 1 year ]OS is defined as the number of days from start of study treatment to time of death. Individuals will be censored at the date of the last study visit if no event occurs. The estimation method used was Kaplan-Meier.
- Duration of Response (DOR) [ Time Frame: 1 year ]Number of weeks from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per RECIST 1.1, CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981524
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Nilofer Azad, MD||The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|