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
Histological diagnosis of primary, localised rectal adenocarcinoma (cT2N0M0 to cT3bN2M0, TNM classification version 8
Diagnosis of Proficient Mismatch Repair (pMMR) rectal adenocarcinoma (using biopsy from the initial diagnostic endoscopy)
Suitable for potentially curative surgical resection
No contraindications for treatment with pembrolizumab
Have impending bowel obstruction or other indications for acute surgical intervention
Have had concurrent immunotherapy in the 3 months before the start of the study therapy.
Have acute or chronic hepatitis B or hepatitis C infection
Known HIV disease
Henry Smith
Lead sponsor
Bispebjerg Hospital
Sponsor institution
Transgene
Collaborator
Rigshospitalet, Denmark
Collaborator