A Study of Enhancing Response to MK-3475 in Advanced Colorectal Cancer (NCT02512172) | Clinical Trial Compass
CompletedPhase 1
A Study of Enhancing Response to MK-3475 in Advanced Colorectal Cancer
United States27 participantsStarted 2016-02-19
Plain-language summary
This study is being done to test the safety and effectiveness of the combination of intravenous (IV) romidepsin and/or oral 5-azacitidine with IV MK-3475 in people with microsatellite stable (MSS) advanced colorectal cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Have histologically confirmed microsatellite stable metastatic colorectal cancer and have received at least one line of treatment for metastatic colorectal cancer including fluoropyrimidines, oxaliplatin and/or irinotecan
ā. Be willing and able to provide written informed consent/assent for the trial
ā. Be 18 years of age on day of signing informed consent
ā. Have measurable disease
ā. Have biopsiable disease. If biopsy is attempted and unsuccessful (the patient undergoes an invasive procedure), the patient may still be treated
ā. Have a performance status of 0 or 1 on the ECOG Performance Scale at study entry
ā. Demonstrate adequate organ function
ā. Female subject of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
Exclusion criteria
ā. Patients whose tumors have progressed at the first restaging during first line therapy
ā. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
ā. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
What they're measuring
1
Degree of change in tumor infiltrating lymphocytes
Timeframe: 1 year
2
Number of Patients Experiencing a DLT (dose-limiting toxicity) as defined by NCI CTCAE v4.0
Timeframe: 5 years
Trial details
NCT IDNCT02512172
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ā. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
ā. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks (6 weeks for nitrosureas or mitomycin C) prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent
ā. Has a known additional malignancy that is progressing or requires active treatment
ā. Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
ā. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.