Oncolytic Virotherapy to Enhance PReoperative IMmunotherapy Efficacy in Patients With Proficient … (NCT07687875) | Clinical Trial Compass
RecruitingPhase 1
Oncolytic Virotherapy to Enhance PReoperative IMmunotherapy Efficacy in Patients With Proficient Mismatch Repair (pMMR) Rectal Cancer
Denmark20 participantsStarted 2026-06-17
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Not requiring neoadjuvant therapy
* Aged \> 18 years at the time of inclusion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Have baseline laboratory results as follows:
* Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
* Platelets ≥ 100 ×109/L (without platelet transfusion)
* Haemoglobin ≥ 6.2 mmol/L or 10.0 g/dL (with or without red blood cell (RBC) transfusion)
* Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
* Bilirubin \< 1.5 × ULN (or \< 2.5 x ULN in patients with Gilbert's syndrome)
* ALT, AST and alkaline phosphatase \< 3 × ULN
* Provide written informed consent in accordance with all applicable regulations and follow the study procedures. Subjects must be capable of understanding the investigational nature, potential risks, and benefits of the study.
Exclusion Criteria:
* 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
* Evidence of immunosuppression for any reaso…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall incidence of adverse events (AEs)
Timeframe: Within 30 days of the end of the study treatment
2
Overall incidence of serious adverse events (SAEs)
Timeframe: Within 30 days of the end of the study treatment
3
Overall incidence of dose limiting toxicities (DLTs)
Timeframe: Within 30 days of the end of the study treatment