A Phase I clinical trial that will investigate the safety and tolerability of combining the modified vaccinia virus BT-001 with systemic pembrolizumab in patients with localised pMMR rectal cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Two doses of BT-001 delivered by intra-tumoural injection followed by one systemic dose of pembrolizumab
Copenhagen University Hospital - Bispebjerg and Frederiksberg
Copenhagen, Captial Region, Denmark
RECRUITINGOverall incidence of adverse events (AEs)
Evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Within 30 days of the end of the study treatment
Overall incidence of serious adverse events (SAEs)
Evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Within 30 days of the end of the study treatment
Overall incidence of dose limiting toxicities (DLTs)
Incidence of dose-limiting toxicities
Time frame: Within 30 days of the end of the study treatment
Clinical efficacy of BT-001 when delivered by endoscopic/transrectal ultrasound guided intra-tumoural injection in combination with a single systemic dose of pembrolizumab in patients with primary, localised, rectal cancer with proficient mismatch repair
Defined as the proportion of patients achieving a complete or major pathological response.
Time frame: Within 6 weeks of the start of the study treatment
Effects of the study treatment on long-term oncological outcomes
Percentage of patients developing local recurrence and/or distant metastases at 1-, 3- and 5-years' follow-up
Time frame: Up to 5 years after the end of the study treatment
Determine the effects of the study treatment on patient's quality of life
Assessed using the EORTC QLQ (European Organisation for Research and Treatment of Cancer Qulaity of Life Questionaire) CR29 questionnaire at baseline, 1 month after surgery, and 1-, 3- and 5-years' follow-up. Higher score means a poorer outcome. Minimum score 29, maximum score 116.
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Time frame: Up to 5 years after the end of the study treatment
Determine the effects of the study treatment on patient's quality of life
Assessed using the EQ (Euroqol) 5D questionnaire at baseline, 1 month after surgery, and 1-, 3- and 5-years' follow-up. Higher scores mean a better outcome. Minimum score 0, maximum score 100
Time frame: Up to 5 years after the end of the study treatment
Determine the effects of the study treatment on patient's quality of life
Assessed using the LARS (low anterior resection syndrome) questionnaire at baseline, 1 month after surgery, and 1-, 3- and 5-years' follow-up. Higher score means poorer outcome. Minimum score 0, maximum score 42.
Time frame: Up to 5 years after the end of the study treatment