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OncoMatch/Clinical Trials/NCT07687875

Oncolytic Virotherapy to Enhance PReoperative IMmunotherapy Efficacy in Patients With Proficient Mismatch Repair (pMMR) Rectal Cancer

Is NCT07687875 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1 trial studies BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody) for rectal cancer patients.

Phase 1RecruitingHenry SmithNCT07687875Data as of Jul 2026Location: Denmark

Treatment: BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody)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

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Extracted eligibility criteria

Treatments studied

Immunotherapy

BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody)

Cancer type

Colorectal Cancer

Biomarker criteria

Required: Mismatch-repair proficient (pMMR / MSS)

Disease stage

Required: Stage CT2N0M0, CT2N1M0, CT2N2M0, CT3AN0M0, CT3AN1M0, CT3AN2M0, CT3BN0M0, CT3BN1M0, CT3BN2M0 (other)

primary, localised rectal adenocarcinoma (cT2N0M0 to cT3bN2M0, TNM classification version 8

Performance status

ECOG 0–1(Restricted strenuous activity)

ECOG performance status of 0 or 1

Prior therapy

Cannot have received: neoadjuvant therapy

Not requiring neoadjuvant therapy

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L; Platelets ≥ 100 ×10^9/L (without platelet transfusion); Haemoglobin ≥ 6.2 mmol/L or 10.0 g/dL (with or without red blood cell (RBC) transfusion)

Kidney function

Serum creatinine ≤ 1.5 × upper limit of normal (ULN)

Liver function

Bilirubin < 1.5 × ULN (or < 2.5 x ULN in patients with Gilbert's syndrome); ALT, AST and alkaline phosphatase < 3 × ULN

Have baseline laboratory results as follows: * Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L * Platelets ≥ 100 ×10^9/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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07687875 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior neoadjuvant therapy disqualifies patients from enrollment.

Does this trial require MLH1?

Yes, MLH1 wild-type is a required biomarker for enrollment.

Does this trial require MSH2?

Yes, MSH2 wild-type is a required biomarker for enrollment.

Does this trial require MSH6?

Yes, MSH6 wild-type is a required biomarker for enrollment.

What disease stage is eligible?

Stage CT2N0M0 or CT2N1M0 or CT2N2M0 or CT3AN0M0 or CT3AN1M0 or CT3AN2M0 or CT3BN0M0 or CT3BN1M0 or CT3BN2M0 is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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