Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer (NCT02981524) | Clinical Trial Compass
CompletedPhase 2
Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer
United States17 participantsStarted 2017-05-26
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Documented mismatch repair-proficient cancer of colorectum, who have received at least two prior lines of therapy for metastatic disease
✓. Measurable disease by RECIST v1.1
✓. Age \>18 years
✓. ECOG Performance Status of 0 to 1
✓. Estimated life expectancy of greater than 3 months.
✓. Adequate organ function as defined by study-specified laboratory tests
✓. Must use acceptable form of birth control through the study and for 120 days after final dose of study drug
✓. Signed informed consent form
Exclusion criteria
✕. Has a known additional malignancy that is progressing or requires active treatment.
✕. Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
✕. Has known malignant small bowel obstruction within the last 6 months.
✕. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
✕. Systemically active steroid use.
✕
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: up to 1 year
Trial details
NCT IDNCT02981524
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins