Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer
Starting soon · Phase 2
Conditions studied: DMMR Colorectal Cancer, Colon Cancer Stage I, Colon Cancer Stage II/III, Pembrolizumab, Immunotherapy
In brief
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.
Key facts
- Study ID
- NCT07409844
- Run by
- Ismail Gögenur
- People needed
- 152
- Starts
- 2026-03-01
- Expected to finish
- 2031-01-01
- Last updated by the study team
- 2026-02-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Written informed consent
- Clinical UICC stage I-III dMMR colon carcinoma
- Indication for elective curative-intent surgery
- ECOG status 0-2
You may not qualify if…
- Patients deemed to be non-surgical candidates by MDT
- Patients with a need for emergent surgery due to tumour obstruction
- 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)
- 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:
- Danish language skills insufficient to answer PROMs
- Unable to use eBoks
Where it is running
- Zealand University Hospital — Køge, Denmark
Full record on ClinicalTrials.gov
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