Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:1/13/2019
Start Date:May 26, 2017
End Date:March 2025

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A Phase 2 Study of GVAX Colon Vaccine (With Cyclophosphamide) and Pembrolizumab in Patients With Mismatch Repair-Proficient (MMR-p) Advanced Colorectal Cancer

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.


Inclusion Criteria:

1. Documented mismatch repair-proficient cancer of colorectum, who have received at least
two prior lines of therapy for metastatic disease

2. ECOG Performance Status of 0 to 1

3. Adequate organ function as defined by study-specified laboratory tests

4. Must use acceptable form of birth control through the study and for 120 days after
final dose of study drug

5. Signed informed consent form

6. Willing and able to comply with study procedures

Exclusion Criteria:

1. Currently have or have history of certain study-specified heart, liver, kidney, lung,
neurological, immune or other medical conditions

2. Systemically active steroid use

3. Another investigational product within 28 days prior to receiving study drug

4. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring
within 28 days prior to receiving study drug

5. Chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior
to receiving study drug

6. Pregnant or lactating

7. Unwilling or unable to comply with study procedures
We found this trial at
1
site
Baltimore, Maryland 21231
410-955-6190
Phone: 410-614-7186
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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mi
from
Baltimore, MD
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