Tests pembrolizumab before surgery in colon cancer with mismatch repair deficiency
Tests pembrolizumab before surgery in adults with localized colon cancer that is mismatch repair deficient.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer
Key facts
- Where
- Aalborg, Aarhus N, Copenhagen Oe, Esbjerg, Herlev, Herning, Koege, Odense C, Sønderborg, and Vejle, DenmarkSee the 10 sites
- Phase
- Phase 2
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkNot yet recruiting
- Aarhus University HospitalAarhus N, DenmarkNot yet recruiting
- RigshospitaletCopenhagen Oe, DenmarkNot yet recruiting
- Esbjerg Og Grindsted SygehusEsbjerg, DenmarkNot yet recruiting
- Herlev HospitalHerlev, DenmarkNot yet recruiting
- Gødstrup Regional HospitalHerning, DenmarkNot yet recruiting
- Zealand University HospitalKoege, DenmarkNot yet recruiting
- Odense University HospitalOdense C, DenmarkNot yet recruiting
- Sygehus Sønderjylland, SønderborgSønderborg, DenmarkNot yet recruiting
- Lillebaelt HospitalVejle, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ismail Gögenur
- Trial code
- NCT07409844EU 2026-525214-62-00
- Record updated
- 20 February 2026
- Original description
The RESET C2 trial aims to introduce organ sparing treatment or watch-and-wait (WW) to patients with localized deficient mismatch repair (dMMR) colon cancer through use of neoadjuvant pembrolizumab. Patients will be divided into four treatment arms based on their surgical and oncologic risks. Each arm provides different intensity neoadjuvant immunotherapy regimens. Patients with complete response at disease restaging procedures will be offered non-operative management, whereas those with non-complete response will proceed to surgery ± adjuvant chemotherapy as standard of care. A WW protocol with regular disease surveillance continues over survivorship. If there is recurrence, surgery and/or appropriate oncologic therapy will be offered determined by multi-disciplinary teams. This is a national, non-randomised, investigator-initiated trial including patients from 13 hospitals across Denmark. The rationale, design, and clinical response metrics are derived from the RESET C study (NCT05662527) showing efficacy, safety and feasibility of neoadjuvant pembrolizumab in this cohort.Read full original descriptionShow less
Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)
The RESET C2 trial aims to introduce organ sparing treatment or watch-and-wait (WW) to patients with localized deficient mismatch repair (dMMR) colon cancer through use of neoadjuvant pembrolizumab. Patients will be divided into four treatment arms based on their surgical and oncologic risks. Each arm provides different intensity neoadjuvant immunotherapy regimens. Patients with complete response at disease restaging procedures will be offered non-operative management, whereas those with non-complete response will proceed to surgery ± adjuvant chemotherapy as standard of care. A WW protocol with regular disease surveillance continues over survivorship. If there is recurrence, surgery and/or appropriate oncologic therapy will be offered determined by multi-disciplinary teams. This is a national, non-randomised, investigator-initiated trial including patients from 13 hospitals across Denmark. The rationale, design, and clinical response metrics are derived from the RESET C study (NCT05662527) showing efficacy, safety and feasibility of neoadjuvant pembrolizumab in this cohort.
Inclusion: Age ≥ 18 years; Written informed consent; Clinical UICC stage I-III dMMR colon carcinoma; Indication for elective curative-intent surgery; ECOG status 0-2.
Exclusion: Patients deemed to be non-surgical candidates by MDT; Patients with a need for emergent surgery due to tumour obstruction; Concurrent tumours (e.g., patients with prostate cancer may be included if this does not hinder their other cancer treatment or assessments of efficacy); In the following circumstance patients may be excluded from the PROMs outcomes:; Contraindications to pembrolizumab, including allergy and hypersensitivity reactions, assessed by the study investigator(s); Any serious or uncontrolled medical disorder, including other malignant disease, that may increase the risk associated with participation or drug administration; Patients with colonic stents; Additional Circumstances:; In the following circumstances, eligibility will be individually verified:; Synchronous colonic tumours (may be included if other lesions are biopsy-verified with dMMR status); Danish language skills insufficient to answer PROMs; Unable to use eBoks.