This is a single center, open-label, phase I study to evaluate the safety and preliminary efficacy of MRx0518 with preoperative hypofractionated radiation in 15 patients with resectable pancreatic cancer. Subjects will take MRx0518 daily for one week prior to the start of radiation therapy, throughout radiation and until surgical resection of the tumour.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
MRx0518 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is one capsule two times per day for the duration of the treatment period.
Radiation will be delivered as 30Gy/10 fractions over two weeks.
MD Anderson Cancer Center
Houston, Texas, United States
To assess the safety of MRx0518 in combination with hypofractionated preoperative radiation through the collection of adverse events
Adverse events will be assessed as per CTCAE v5.0
Time frame: Up to 1 year post completion of radiation
Major pathologic response
Major pathologic response is defined as \<5% viable cells in resected tumour specimen
Time frame: At time of surgery
Tumour infiltrating lymphocytes (TILs)
Changes in TILs from optional baseline biopsy to resected tumour specimen will be assessed.
Time frame: Baseline to Surgery
Overall Survival (OS)
OS is defined as the duration from the start of study treatment until death due to any cause
Time frame: 12 months post radiation
Progression Free Survival (PFS)
PFS is defined as the duration from the start of study treatment until disease progression or death
Time frame: 12 months post radiation
Local Control
Local control is defined as absence of progression at the primary site and will be assessed with imaging
Time frame: 6 months post radiation
Distant Control
Distant control is defined as absence of progression at any site other than the primary site and will be assessed with imaging
Time frame: 6 months post radiation
Margin status
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The margin status of the tumour at the time of surgery will be assessed
Time frame: At time of surgery