PEMBROLIZUMAB for Mismatch repair-deficient (dMMR) colon cancer|Localised colon adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Clinical UICC stage I-III dMMR colon adenocarcinoma\n- Age ≥18 years\n- Written informed consent\n- Indication for elective curative-intent surgery"}

Exclusion criteria

• {"criterion_text":"- Patients deemed to be non-surgical candidates by MDT\n- Patients with a need for emergent surgery due to tumour obstruction\n- Contraindications to pembrolizumab, assessed by the study investigator(s)\n- Any serious or uncontrolled medical disorder, including other malignant disease, that may increase the risk associated with participation or drug administration.\n- Patients with colonic stents"}

Primary endpoints

• {"endpoint_text":"- Compete Clinical response: Local response on endoscopy, no metastatic disease on CT imaging at reassessment","definition_or_measurement_approach":"Clinical complete response defined as local response on endoscopy and absence of metastatic disease on CT imaging at reassessment."}

Secondary endpoints

• {"endpoint_text":"- Overall Survival: Death from any cause from inclusion to 36 months after\n- Disease Free Survival: Death from any cause or disease recurrence from inclusion to 36 months after\n- 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)\n- Adverse Events to Pembrolizumab: As defined by the NCI Common Terminology Criteria for Adverse Events, from pembrolizumab administration to 12 months post\n- Adverse events related to surgery: Surgical Complications as defined by the Clavien-Dindo classification system from the day of surgery to 90 days postoperatively\n- Adverse events related to endoscopy: As defined by the ASGE Lexicon, from the day of endoscopy to 7 days after\n- Healthcare Utilisation: As defined as planned or unplanned use of hospital admissions from inclusion to 90 days post definitive treatment\n- Healthcare Utilisation: As defined as planned or unplanned use of intensive care admissions from inclusion to 90 days post definitive treatment\n- Healthcare Utilisation: As defined as planned or unplanned use of outpatient encounters from inclusion to 90 days post definitive treatment\n- 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\n- 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\n- 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\n- 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\n- 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\n- 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\n- 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\n- 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\n- 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\n- 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\n- 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\n- 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\n- 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","definition_or_measurement_approach":"Each secondary endpoint includes its measurement/definition in the endpoint text. Examples: Overall Survival = death from any cause from inclusion to 36 months; Disease Free Survival = death or disease recurrence from inclusion to 36 months; Adverse events to pembrolizumab = defined by NCI CTCAE from administration to 12 months post; Surgical complications = Clavien-Dindo classification from day of surgery to 90 days; Endoscopy AEs = ASGE Lexicon from day of endoscopy to 7 days; QoL measures = changes in listed validated instruments (EORTC QLQ-C30, QLQ-CR29, EQ-5D-5L, FACIT-Fatigue, Fear of Cancer Recurrence Short Form, Colon Cancer Dysfunction Score) at specified time points; Prehabilitation efficacy measured by specified functional tests (6-minute walk, Sit to Stand, hand grip, BORG, G8, NPAQ-Short) at listed time points."}

Denmark

Earliest CTIS Part Ii Submission Date

27-04-2026

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

10

Number Of Sites

13

Number Of Participants

152

Primary sponsor

Full Name

Region Sjaelland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"Sponsor duties codes: 1, 7, 8 (as listed in record)","organisation_type":"Regulatory Authority"}