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NCT07409844: RESET C2
Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer
Phase 2 trial testing 1 Cycle of Pembrolizumab in DMMR Colorectal Cancer in 152 participants. Not yet recruiting.
1 March 2028
Quick facts
| Lead sponsor | Ismail Gögenur |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 152 |
| Start date | 1 March 2026 |
| Primary completion | 1 March 2028 |
| Estimated completion | 1 January 2031 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- 1 Cycle of Pembrolizumab — full drug profile →
- 2 Cycles of Pembrolizumab — full drug profile →
- 3 Cycles of Pembrolizumab — full drug profile →
- Additional Cycle of Pembrolizumab — full drug profile →
Conditions studied
- DMMR Colorectal Cancer — all drugs for DMMR Colorectal Cancer →
- Colon Cancer Stage I — all drugs for Colon Cancer Stage I →
- Colon Cancer Stage II/III — all drugs for Colon Cancer Stage II/III →
- Pembrolizumab — all drugs for Pembrolizumab →
Sponsor
Ismail Gögenur — full company profile →
Who can join
18 and older, any sex, with DMMR Colorectal Cancer or Colon Cancer Stage I. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07409844
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for DMMR Colorectal Cancer
Currently open trials in the same condition.
- NCT04301557 — PD1 Antibody Toripalimab and Chemoradiotherapy for dMMR/MSI-H Locally Advanced Colorectal Cancer · Phase 2 · active not recruiting
Other Ismail Gögenur trials
Trials by the same sponsor.
- NCT05740969 — Gene and Protein Expression Profiles After Treatment of Actinic Keratoses · Phase 2 · unknown
- NCT05609656 — Electroporation and Immunotherapy in Metastatic Colorectal Cancer · Phase 2 · terminated
- NCT05740137 — Adenoma Detection Rate in Artificial Intelligence-assisted Colonoscopy · NA · completed
- NCT05754229 — Accuracy of Real Time Characterization in Artificial Intelligence-assisted Colonoscopy · NA · unknown
- NCT05435053 — Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07409844 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ismail Gögenur
- Last refreshed: 20 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07409844.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing