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Tests treatment safety and results for Rectal Cancer Patients
Official title Oncolytic Virotherapy to Enhance PReoperative IMmunotherapy Efficacy in Patients With Proficient Mismatch Repair (pMMR) Rectal Cancer
ClinicalTrials.gov ID: NCT07687875
What this study is testing
What is BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody)?
BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for rectal cancer patients.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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. people must be capable of understanding the investigational nature, potential risks, and benefits of the...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Captial Region, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Captial Region, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.