Clinical trial · Interventional
Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer
Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer Stage I | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Colon Cancer Stage II/III | Colon Neoplasm | PROBABILISTIC | 0.70 |
| DMMR Colorectal Cancer | dMMR Colorectal Carcinoma | ALIAS | 0.90 |
| Immunotherapy | — | UNRESOLVED | — |
| Pembrolizumab | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1 Cycle of Pembrolizumab | Drug | — | UNRESOLVED |
| 2 Cycles of Pembrolizumab | Drug | — | UNRESOLVED |
| 3 Cycles of Pembrolizumab | Drug | — | UNRESOLVED |
| Additional Cycle of Pembrolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Low and medium surgical risk participants with stage I-II CRC
- description
- These participants receive 1 cycle of up-front pembrolizumab before disease re-assessment. An additional cycle may given in the case of non-complete response
- interventionNames
- Drug: 1 Cycle of Pembrolizumab
- Drug: Additional Cycle of Pembrolizumab
- type
- EXPERIMENTAL
- label
- Low and medium surgical risk participants with stage III CRC
- description
- These participants receive 2 cycles of up-front pembrolizumab before disease re-assessment (no additional cycles are offered if non-complete response)
- interventionNames
- Drug: 2 Cycles of Pembrolizumab
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Written informed consent 3. Clinical UICC stage I-III dMMR colon carcinoma 4. Indication for elective curative-intent surgery 5. ECOG status 0-2 Exclusion Criteria: 1. Patients deemed to be non-surgical candidates by MDT 2. Patients with a need for emergent surgery due to tumour obstruction 3. Contraindications to pembrolizumab, including allergy and hypersensitivity reactions, assessed by the study investigator(s) 4. Any serious or uncontrolled medical disorder, including other malignant disease, that may increase the risk associated with participation or drug administration. 5. 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
References
Publications (0)
Data not yet available