Reset C2

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Sjaelland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-05-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Læge Sofus Carl Emil · Frimodt Heineke Foundation · Grosserer LF Foghts Foundation · Vissing Foundation · Axel Muusfeldts Foundation · Novo Nordisk Foundation

External identifiers

EU CT number

2026-525214-62-00

ClinicalTrials.gov

NCT07409844

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Proportion of patients with clinical complete response (cCR) at the end of pembrolizumab treatment

Secondary objectives 9

1. Overall survival
2. Disease free survival
3. Rate of complete response and major pathologic response in patients that undergo surgery
4. Adverse events releated to pembrolizumab from administration
5. Adverse events related to surgery from the day of surgery
6. Adverse events related to endoscopy from the day of endoscopy
7. Healthcare utilisation
8. Quality of Life
9. Efficacy of prehabilitation

Conditions and MedDRA coding

Localised dMMR Colon Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Clinical UICC stage I-III dMMR colon adenocarcinoma
2. Age ≥18 years
3. Written informed consent
4. Indication for elective curative-intent surgery

Exclusion criteria 5

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, 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Compete Clinical response: Local response on endoscopy, no metastatic disease on CT imaging at reassessment

Secondary endpoints 22

1. Overall Survival: Death from any cause from inclusion to 36 months after
2. Disease Free Survival: Death from any cause or disease recurrence from inclusion to 36 months after
3. Response Rates in Surgical Patients: Rates of complete pathological response (Mandard Tumour Grade Regression 1) and major pathologic response (Mandard Tumour Grade Regression 1 and 2)
4. Adverse Events to Pembrolizumab: As defined by the NCI Common Terminology Criteria for Adverse Events, from pembrolizumab administration to 12 months post
5. Adverse events related to surgery: Surgical Complications as defined by the Clavien-Dindo classification system from the day of surgery to 90 days postoperatively
6. Adverse events related to endoscopy: As defined by the ASGE Lexicon, from the day of endoscopy to 7 days after
7. Healthcare Utilisation: As defined as planned or unplanned use of hospital admissions from inclusion to 90 days post definitive treatment
8. Healthcare Utilisation: As defined as planned or unplanned use of intensive care admissions from inclusion to 90 days post definitive treatment
9. Healthcare Utilisation: As defined as planned or unplanned use of outpatient encounters from inclusion to 90 days post definitive treatment
10. Quality of Life: As defined as a change in the EORTC QLQ-C30 between patients in watchful waiting, patients who undergo surgery after neoadjuvant treatment and patients in the surgical comparator group before, during and 3, 6, 12, 24 and 60 months post treatment
11. Quality of Life: As defined as a change in the EORTC QLQ-CR29 between patients in watchful waiting, patients who undergo surgery after neoadjuvant treatment and patients in the surgical comparator group before, during and 3, 6, 12, 24 and 60 months post treatment
12. Quality of Life: As defined as a change in the Colon Cancer Dysfunction Score between patients in watchful waiting, patients who undergo surgery after neoadjuvant treatment and patients in the surgical comparator group before, during and 3, 6, 12, 24 and 60 months post treatment
13. Quality of Life: As defined as a change in the EQ-5D-5L between patients in watchful waiting, patients who undergo surgery after neoadjuvant treatment and patients in the surgical comparator group before, during and 3, 6, 12, 24 and 60 months post treatment
14. Quality of Life: As defined as a change in the FACIT-Fatigue between patients in watchful waiting, patients who undergo surgery after neoadjuvant treatment and patients in the surgical comparator group before, during and 3, 6, 12, 24 and 60 months post treatment
15. Quality of Life: As defined as a change in the Fear of Cancer Recurrence Short Form between patients in watchful waiting, patients who undergo surgery after neoadjuvant treatment and patients in the surgical comparator group before, during and 3, 6, 12, 24 and 60 months post treatment
16. Quality of Life: As defined as a change in the Quality of Recovery 15 questionnaire measured at post operative day 0, 2 and 14 compared between the patients who undergo surgery after neoadjuvant treatment against patients in the comparator group
17. Efficacy of prehabilitation: As measured as changes in the 6 minute walk test in patients who undergo supervised training as part of their prehabilitation at enrolment, after each cycle of immunotherapy and 3 months after definitive treatment
18. Efficacy of prehabilitation: As measured as changes in the Sit to Stand Test in patients who undergo supervised training as part of their prehabilitation at enrolment, after each cycle of immunotherapy and 3 months after definitive treatment
19. Efficacy of prehabilitation: As measured as changes in the hand grip strength test in patients who undergo supervised training as part of their prehabilitation at enrolment, after each cycle of immunotherapy and 3 months after definitive treatment
20. Efficacy of prehabilitation: As measured as changes in the BORG Scale in patients who undergo supervised training as part of their prehabilitation at enrolment, after each cycle of immunotherapy and 3 months after definitive treatment
21. Efficacy of prehabilitation: As measured as changes in the G8 frailty score in patients who undergo supervised training as part of their prehabilitation at enrolment, after each cycle of immunotherapy and 3 months after definitive treatment
22. Efficacy of Prehabilitation: As defined as a change in the NPAQ-Short at at inclusion, during treatment and 3, 6, 12, 24 and 60 months post treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Sjaelland

Sponsor organisation

Region Sjaelland

Address

Lykkebaekvej 1

City

Koege

Postcode

4600

Country

Denmark

Scientific contact point

Organisation

Region Sjaelland

Contact name

Ismail Gögenur

Public contact point

Organisation

Region Sjaelland

Contact name

Ismail Gögenur

Third parties 1

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications