Metastatic Colorectal Cancer Clinical Trial
Official title:
A Phase 2 Study of Pembrolizumab (MK-3475) in Combination With Azacitidine in Subjects With Chemo-refractory Metastatic Colorectal Cancer
This is an open label, single-arm, Phase 2 trial to evaluate the anti-tumor activity, safety,
and tolerability of Pembrolizumab in combination with azacitidine in subjects with
chemo-refractory mCRC without any further standard treatment options
Dosage and regimen for all study periods
- Pembrolizumab will be given at 200 mg every 21 days.
- Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21
days.
The first assessment of tumor response will be performed after cycle 3 (9 weeks), and
thereafter approximately every 9 weeks, every 3 cycles of therapy. The modified RECIST 1.1
will be used to establish disease response or progression.
All patients will be evaluated and graded for adverse events according to the NCI Common
Terminology for Adverse Events, version 4.0 (NCI-CTCAE).
n/a
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