Rectal Cancer PatientsPhase 1OV-PRIME-RNCT07687875
Oncolytic Virotherapy to Enhance PReoperative IMmunotherapy Efficacy in Patients With Proficient Mismatch Repair (pMMR) Rectal Cancer
A Phase 1 study testing BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody) in people with Rectal Cancer Patients, run by Henry Smith at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer Patients
- What is being tested?
- BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Oct 2026to 31 Dec 2033
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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 reason:
- Known HIV disease
- Chronic oral or systemic steroid medication use at a dose of > 10 mg/day of prednisolone or equivalent
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- Other signs or symptoms of clinical immune system suppression
- Have an autoimmune disorder (except thyroiditis with replacement therapy and type I diabetes mellitus)
- Have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- Ongoing antiviral therapy active on vaccinia virus, e.g., ribavirin, cidofovir, interferon/ pegylated interferon
- History of severe exfoliative skin conditions (e.g., eczema or atopic dermatitis) requiring systemic therapy for more than 4 weeks within 2 years prior to BT-001 initiation
- Live virus vaccination within 28 days of BT-001 administration
- A history of hypersensitivity to egg or to any excipient of BT-001
- Pregnant or breast-feeding female. Confirmation that women of childbearing potential are not pregnant with a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test results must be obtained within 7 days prior to the 1st administration of BT-001
- Fertile males and females who are unwilling to employ highly effective means of contraception during study treatment and for 4 months after the last dose of study treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital - Bispebjerg and Frederiksberg
Copenhagen, Captial Region, 2400
Henry G Smith, PhD, +4521701936, henry.george.smith@regionh.dk
Mette B Barrit, +4538635602, mette.brogaard.barrit@regionh.dk
About this study
Official title: A Phase I Study of the Safety and Efficacy of a Modified Vaccinia Virus (BT-001) Delivered by Endoscopic Intra-tumoural Injection Followed by Systemic Antiprogammed Death-1 (Anti-PD-1) Antibodies in Patients With Localised Rectal Cancer With Proficient Mismatch Repair (pMMR)
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
- Conditions
- Rectal Cancer Patients
- Being tested
- BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody)
- Keywords
- Rectal Cancer, Immunotherapy, Oncolytic Virotherapy, Proficient mismatch repair
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody)Drug
Two doses of BT-001 delivered by intra-tumoural injection followed by one systemic dose of pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BT-001 and pembrolizumab | Experimental | Two doses of BT-001 delivered by intra-tumoural injection followed by one systemic dose of pembrolizumab Receives: Drug: BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of adverse events (AEs)
Evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 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.
Measured: Within 30 days of the end of the study treatment
Overall incidence of dose limiting toxicities (DLTs)
Incidence of dose-limiting toxicities
Measured: Within 30 days of the end of the study treatment
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to 5 years after the end of the study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start23 Oct 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Smith
- Sponsor type
- University, hospital or other
- Collaborators
- Transgene, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Henry Smith, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687875
- Sponsor's protocol ID
- P2025-19092
- Other IDs
- 2025-524375-23-00, 2025
- Acronym
- OV-PRIME-R
- Status last verified
- Nov 2026
- First submitted
- 20 Jun 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results of this study may be shared after de-identification. Access to trial IPD can be requested by qualified researchers engaging in relevant independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Efficacy of a Modified Vaccinia Virus (BT-001) Delivered by Endoscopic Intra-tumoural Injection Followed by Systemic Antiprogammed Death-1 (Anti-PD-1) Antibodies in Patients With Localised Rectal Cancer With Proficient Mismatch Repair (pMMR)
- ClinicalTrials.gov ID
- NCT07687875
- Acronym / sponsor ID
- OV-PRIME-R / P2025-19092
- Conditions
- Rectal Cancer Patients
- Keywords
- Rectal Cancer, Immunotherapy, Oncolytic Virotherapy, Proficient mismatch repair
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henry SmithUniversity, hospital or other
- Collaborators
- Transgene, Copenhagen University Hospital, Rigshospitalet
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with BT-001 and pembrolizumab | Experimental | Drug: BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody)Two doses of BT-001 delivered by intra-tumoural injection followed by one systemic dose of pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (15 listed)
- 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 reason:
- Have an autoimmune disorder (except thyroiditis with replacement therapy and type I diabetes mellitus)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody)Two doses of BT-001 delivered by intra-tumoural injection followed by one systemic dose of pembrolizumab | Drug | Treatment with BT-001 and pembrolizumab |
Primary outcome
Overall incidence of adverse events (AEs)
Time frame: Within 30 days of the end of the study treatment
Evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Overall incidence of serious adverse events (SAEs)
Time frame: Within 30 days of the end of the study treatment
Evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Overall incidence of dose limiting toxicities (DLTs)
Time frame: Within 30 days of the end of the study treatment
Incidence of dose-limiting toxicities
5 secondary outcomes
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
Time frame: Within 6 weeks of the start of the study treatment
Effects of the study treatment on long-term oncological outcomes
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
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
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
Time frame: Up to 5 years after the end of the study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results of this study may be shared after de-identification. Access to trial IPD can be requested by qualified researchers engaging in relevant independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody) in people with Rectal Cancer Patients, run by Henry Smith at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henry G Smith, PhD (+4521701936, henry.george.smith@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of adverse events (AEs) (time frame: Within 30 days of the end of the study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.