A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04193904|
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : May 24, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: MRx0518 Radiation: Hypofractionated Preoperative Radiation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Preliminary Efficacy Study of the Oral Live Biotherapeutic MRx0518 With Hypofractionated Preoperative Radiation for Resectable Pancreatic Cancer|
|Actual Study Start Date :||December 20, 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: MRx0518 with hypofractionated preoperative radiation
Subjects will take one capsule of MRx0518 twice daily from one week prior to radiation therapy until surgical resection (6 to 9 weeks approx.) Radiation therapy will be delivered as 30Gy/10 fractions over 2 weeks.
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: Hypofractionated Preoperative Radiation
Radiation will be delivered as 30Gy/10 fractions over two weeks.
- To assess the safety of MRx0518 in combination with hypofractionated preoperative radiation through the collection of adverse events [ Time Frame: Up to 1 year post completion of radiation ]Adverse events will be assessed as per CTCAE v5.0
- Major pathologic response [ Time Frame: At time of surgery ]Major pathologic response is defined as <5% viable cells in resected tumour specimen
- Tumour infiltrating lymphocytes (TILs) [ Time Frame: Baseline to Surgery ]Changes in TILs from optional baseline biopsy to resected tumour specimen will be assessed.
- Overall Survival (OS) [ Time Frame: 12 months post radiation ]OS is defined as the duration from the start of study treatment until death due to any cause
- Progression Free Survival (PFS) [ Time Frame: 12 months post radiation ]PFS is defined as the duration from the start of study treatment until disease progression or death
- Local Control [ Time Frame: 6 months post radiation ]Local control is defined as absence of progression at the primary site and will be assessed with imaging
- Distant Control [ Time Frame: 6 months post radiation ]Distant control is defined as absence of progression at any site other than the primary site and will be assessed with imaging
- Margin status [ Time Frame: At time of surgery ]The margin status of the tumour at the time of surgery will be assessed
- Changes to microbiome [ Time Frame: Baseline to 6 months post completion of radiation ]The microbiome profile of faecal, urine, tumour and duodenum samples will be analysed for changes using the MicroDx platform
- Tumour immune infiltration [ Time Frame: Baseline to Surgery ]Optional biopsies and resection specimens will be assessed for changes in tumour immune infiltrates
- Landscape of immune and stromal cells [ Time Frame: Baseline to Surgery ]Optional biopsy and resection specimens will be catalogued for the landscape of immune and stromal cells
- Changes in Circulating Tumour Cells [ Time Frame: Baseline to 6 months post completion of radiation ]Blood samples will be assessed for presence of circulating tumour cells, circulating tumour DNA and/or circulating immune cells
- Genomic changes [ Time Frame: Baseline to 6 months post completion of radiation ]Whole exome sequencing and transcriptome sequencing from tumour and blood samples will be performed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193904
|Contact: Clinical Operations||+44(0)firstname.lastname@example.org|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Cullen M Taniguchi, MD GIRadOncResearch@mdanderson.org|
|Principal Investigator:||Cullen M Taniguchi, MD||M.D. Anderson Cancer Center|