Conditions: Metastatic Colorectal Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 31
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: 9 cycles

* 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.

Interventions: intervention 1: Pembrolizumab intervention 2: Azacitidine
Intervention descriptions: intervention 1: Pembrolizumab will be given at 200 mg every 21 days intervention 2: Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21 days.

Protocol document: