drugset / Trial / NCT05662527
Response to Immunotherapy in MMR-deficient Localized Colon Cancer
Phase 2
Completed
85 enrolled
Camilla Qvortrup
Aalborg University Hospital · collabAarhus University Hospital · collabBispebjerg Hospital · collabHerlev and Gentofte Hospital · collabHorsens Hospital · collabOdense University Hospital · collabRanders Regional Hospital · collabVejle Hospital · collabZealand University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The aim of this study is to evaluate the safety and efficacy of neoadjuvant treatment with pembrolizumab before colonic resection in patients with early-stage (I-III) deficient mismatch repair (dMMR) colon cancer (CC).
Timeline
- Start
- 2023-02-22
- Primary completion
- 2024-06-06
- Completion
- 2024-06-06
Publications
- Gogenur I, Justesen TF, Tarpgaard LS, Bulut M, Hansen TF, Jensen LH, Rahr HB, Gogenur M, Kirkegaard T, Balsevicius L, Chieng M, Raskov H, Sorensen MKS, Petersen PC, Eriksen JR, Salomon S, Fiehn AK, Mikkelsen MD, Brandsborg S, Gotschalck KA, Emmertsen KJ, Ramlov A, Born PW, Thorlacius-Ussing O, Lauritzen MB, Olesen RK, Poulsen LO, Lykke J, Schou J, Buskov L, Krarup PM, Andersen CL, Pallisgaard N, Pfeiffer P, Qvortrup C. Neoadjuvant Single-Cycle Pembrolizumab for Stage I-III MMR-Deficient Colon Cancer: The RESET-C Trial. J Clin Oncol. 2026 Jun 20;44(18):1687-1696. doi: 10.1200/JCO-25-02274. Epub 2026 May 5.
- Gogenur I, Justesen TF, Tarpgaard LS, Bulut M, Hansen TF, Jensen LH, Rahr HB, Kirkegaard T, Balsevicius L, Raskov H, Petersen PC, Eriksen JR, Salomon S, Fiehn AK, Brandsborg S, Gotschalck KA, Emmertsen KJ, Born PW, Thorlacius-Ussing O, Lauritzen MB, Olesen RK, Poulsen LO, Lykke J, Schou J, Buskov L, Krarup PM, Andersen CL, Pfeiffer P, Qvortrup C. Neoadjuvant Pembrolizumab in Stages I-III Deficient Mismatch Repair Colon Cancer: A Clinical Trial. Ann Surg. 2026 Jun 1;283(6):1075-1081. doi: 10.1097/SLA.0000000000006611. Epub 2024 Dec 18.
- Justesen TF, Gogenur I, Tarpgaard LS, Pfeiffer P, Qvortrup C. Evaluating the efficacy and safety of neoadjuvant pembrolizumab in patients with stage I-III MMR-deficient colon cancer: a national, multicentre, prospective, single-arm, phase II study protocol. BMJ Open. 2023 Jun 22;13(6):e073372. doi: 10.1136/bmjopen-2023-073372.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 4 mg/kg | — |