DMMR Colorectal CancerPhase 2RESET C2NCT07409844
Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer
A Phase 2 study testing 1 Cycle of Pembrolizumab, 2 Cycles of Pembrolizumab and 3 Cycles of Pembrolizumab in people with DMMR Colorectal Cancer and Colon Cancer Stage I, run by Ismail Gögenur at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DMMR Colorectal Cancer, Colon Cancer Stage I, Colon Cancer Stage II/III
- What is being tested?
- 1 Cycle of Pembrolizumab, 2 Cycles of Pembrolizumab and 3 Cycles of Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2026to 1 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Written informed consent
- Clinical UICC stage I-III dMMR colon carcinoma
- Indication for elective curative-intent surgery
- ECOG status 0-2
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Zealand University Hospital
Køge, 4600
Ismail Gögenur Professor, +4526336426, igo@regionsjaelland.dk
About this study
Official title: Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)
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.
Read the detailed description
Organ preservation in colorectal cancer has been pioneered in rectal cancer populations, where watch-and-wait (WW) strategies emerged from total neoadjuvant therapy. RESET C2 aims to brings this same treatment paradigm to colon cancer (CC). Despite improvements in surgical outcomes for CC over time, the risk of relapse and disproportionate complications in frail patients remain core challenges. Avoidance of surgery to limit these risks is attractive from a safety perspective but WW approaches have not been validated as curative and oncologically safe in a CC population. The subgroup of patients with CC and deficient mismatch repair (dMMR) proteins are ideal candidates for investigation as they demonstrate marked sensitivity to immunotherapy, which has the capacity to induce complete responses in a substantial proportion. The question of how this can be best leveraged for maximum benefit in a real-world setting remains to be answered.
In this study, 152 eligible participants will be recruited nationwide across 13 participating sites in Denmark. Following enrolment, clinicians will assign a surgical risk category using a composite of the American society of anaesthesiology (ASA) score and Eastern Cooperative Oncology Group performance status (ECOG). This input is combined with cancer stage data to allocate patients to one of four treatment arms. Depending on allocation, participants will receive between one to three consecutive cycles of up-front 4mg/kg pembrolizumab (max. 400mg) every six weeks. This is followed by a disease re-evaluation step, involving colonoscopy and contrast CT imaging. Colonoscopy is used to determine local disease response, and cross-sectional CT is used to confirm absence of distant disease. Participants with clinical complete response (cCR) will be eligible for WW, and those with non-cCR will be offered additional pembrolizumab before a second/final re-evaluation. Any patients with cCR at the final re-evaluation will be eligible for WW and those with non-cCR will be offered surgery. Quality of life (QoL) and late effects will be captured via patient reported outcome measures (PROMs) which will be distributed after enrolment, during immunotherapy, and at designated timepoints across survivorship. A separate cohort of 250 CC patients who undergo surgery without neoadjuvant treatment will complete identical PROMs and act as a comparator group after surgical treatment. Final analysis will compare QoL and late effects in patients who are allocated to WW (cCR), with those who receive neoadjuvant treatment and proceed to surgery (non-cCR), and finally those who proceed directly to surgery (matched cohort).
Across all treatment arms, enrolled patients will be offered multi-disciplinary prehabilitation. These functional, exercise, and nutrition interventions are graded in intensity and dependent on patient frailty and disease-factors. This forms the backbone of standard-of-care nationally for colorectal cancer patients and is implemented across all participating sites.
- Conditions
- DMMR Colorectal Cancer, Colon Cancer Stage I, Colon Cancer Stage II/III, Pembrolizumab, Immunotherapy
- Being tested
- 1 Cycle of Pembrolizumab, 2 Cycles of Pembrolizumab, 3 Cycles of Pembrolizumab, Additional Cycle of Pembrolizumab
- Keywords
- Pembrolizumab, dMMR, colon cancer, watch-and-wait, organ sparing, neoadjuvant immunotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Cycle of PembrolizumabDrug
Also called Keytruda
1 cycle of 4mg/kg (maximum of 400mg) every 6 weeks
2 Cycles of PembrolizumabDrug
Also called Keytruda
2 Cycles of Pembrolizumab 4mg/kg (maximum of 400mg) every 6 weeks
3 Cycles of PembrolizumabDrug
Also called Keytruda
3 Cycles of Pembrolizumab 4mg/kg (maximum of 400mg) every 6 weeks
Additional Cycle of PembrolizumabDrug
An additional 4mg/kg (maximum of 400mg) cycle of pembrolizumab in the case of non-complete response
| Study group | Role | What they receive |
|---|---|---|
| Low and medium surgical risk participants with stage I-II CRC | Experimental | 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 Receives: Drug: 1 Cycle of Pembrolizumab; Drug: Additional Cycle of Pembrolizumab |
| Low and medium surgical risk participants with stage III CRC | Experimental | These participants receive 2 cycles of up-front pembrolizumab before disease re-assessment (no additional cycles are offered if non-complete response) Receives: Drug: 2 Cycles of Pembrolizumab |
| High surgical risk participants with stage I-II CRC | Active comparator | These participants receive 2 cycles of up-front pembrolizumab before disease re-assessment. An additional cycle may given in the case of non-complete response Receives: Drug: 2 Cycles of Pembrolizumab; Drug: Additional Cycle of Pembrolizumab |
| High surgical risk participants with stage III CRC | Active comparator | These participants receive 3 cycles of up-front pembrolizumab before disease re-assessment. An additional cycle may given in the case of non-complete response Receives: Drug: 3 Cycles of Pembrolizumab; Drug: Additional Cycle of Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with clinical complete response (cCR)
The proportion of patients achieving a clinical complete response defined as 1) the absence of residual local tumour based on predefined endoscopic criteria and 2) absence of metastatic disease on cross-sectional CT imaging. Pathological examination may be performed to support the local tumour response assessment when endoscopic findings are equivocal. These tissue specimens will be reported as per the Mandard Tumour Regression Grading system with pathologic Complete Response (pCR) defined as Mandard Tumour Regression Grade 1.
Measured: Periprocedural
Secondary outcomes (21)
Overall Survival (OS)
Time from inclusion to death from any cause
Measured: Up to 3 years
Disease-free survival (DFS)
Time from inclusion to disease recurrence or death from any cause, whichever occurs first.
Measured: Up to 3 years
Major patholological response (MPR) in patients undergoing surgery as per Mandard TRG
Proportion of patients with no residual tumour cells (Mandard Tumour Regression Grade 1) or rare residual tumour cells (Mandard Tumour Regression Grade 2) in the histopathological section after surgery.
Measured: Perioperative
Adverse events related to pembrolizumab as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Adverse events related to pembrolizumab, assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The scale of adverse events ranges from a minimal value of 1 (mild) to a maximum value of 5 (death) with higher values representing worse outcomes.
Measured: 1 year
Adverse events related to surgery as per Clavien-Dindo (CD) classification
Surgical complications graded according to the Clavien-Dindo (CD) classification system. The scale of complications ranges from a minimal value of 0 (no complications) to a maximum value of 5 (death) with higher values representing worse outcomes.
Measured: Up to 12 weeks
Adverse events related to endoscopy as per American Society for Gastrointestinal Endoscopy (ASGE) lexicon
Endoscopic complications described according to the American Society for Gastrointestinal Endoscopy (ASGE) Lexicon for adverse events. This requires categorical reporting of timing (pre-procedure, intra-procedure, post-procedure <14 days, late >14 days), attribution to procedure (definite, probable, possible, unlikely) and severity grade (mild, moderate, severe, fatal).
Measured: Periprocedural
Planned or unplanned use of hospital services
Number and type of hospital encounters, including inpatient admissions, intensive care admissions, and outpatient visits, occurring in patients managed with watch-and-wait compared to those undergoing surgery. All hospital services will be recorded and analyzed to compare utilization between management strategies.
Measured: Up to 12 weeks
Change in global health status as measured by EORTC QLQ-C30
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a patient reported outcome measure with the following characteristics:
Minimum value: 0. Maximum value: 100. Higher values indicate better outcomes for global health status and functional scales, lower values indicate better outcomes for symptom scales
Measured: Up to 5 years
Change in CRC-related quality of life as measured by EORTC QLQ-CR29
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Colorectal Cancer (EORTC QLQ-CR29) is a patient reported outcome measure with the following characteristics:
Minimum value: 0. Maximum value: 100. Higher values indicate better outcomes for functional scales, lower values indicate better outcomes for symptom scales.
Measured: Up to 5 years
Change in bowel function as measured by CCBDS
The Colon Cancer Bowel Dysfunction Score (CCBDS) is a patient reported outcome measure with the following characteristics:
Minimum value: 0. Maximum value: 36. Lower values indicate better bowel function and less bowel dysfunction.
Measured: Up to 5 years
Change in overall daily function and care needs as measured by EQ-5D-5L
The EuroQol-5 Dimension 5 Levels (EQ-5D-5L) score is a patient reported outcome measure with the following characteristics:
Minimum value: Less than 0. Maximum value: 1. Higher values indicate better health-related quality of life.
Measured: Up to 5 years
Change in fatigue as measured by FACIT-Fatigue
The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) is a patient reported outcome measure with the following characteristics:
Minimum value: 0. Maximum value: 52. Higher values indicate less fatigue and better outcomes.
Measured: Up to 5 years
Change in fear of cancer recurrence as measured by FCRI-SF
The Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF) is a patient reported outcome measure with the following characteristics:
Minimum value: 0. Maximum value: 36. Lower values indicate less fear of cancer recurrence.
Measured: Up to 5 years
Change in post-operative recovery as measured by QoR-15
The Quality of Recovery 15 (QoR-15) is a patient reported outcome measure with the following characteristics:
Minimum value: 0. Maximum value: 150. Higher values indicate better postoperative recovery.
Measured: Up to 5 years
Change in physical activity as measured by NPAQ-Short
The Nordic Physical Activity Questionnaire Short Form (NPAQ-Short) is a patient reported outcome measure with two close-ended question items and categorical responses paired with two ad-hoc items. These assess self-reported hours spent on physical activity in a typical week as well as historic trends and interest in being more physically active.
Measured: Up to 5 years
Change in physical fitness as measured by the 6-minute walk test
Assessment of the efficacy of supervised exercise training during treatment, evaluated by changes in the 6-Minute Walk Test (6MWT)
Measured: Up to 12 weeks
Change in physical fitness as measured by the sit-to-stand test
Assessment of the efficacy of supervised exercise training during treatment, evaluated by changes in the Sit-to-Stand Test
Measured: Up to 12 weeks
Change in physical fitness as measured by hand grip strength
Assessment of the efficacy of supervised exercise training during treatment, evaluated by changes in hand grip strength
Measured: Up to 12 weeks
Change in physical fitness as measured by the Borg Rating of Perceived Exertion scale
Assessment of the efficacy of supervised exercise training during treatment, evaluated by changes in the Borg Rating of Perceived Exertion scale.
Minimum value: 6. Maximal value: 20. Higher values indicate greater perceived effort and exercise intensity.
Measured: Up to 12 weeks
Change in frailty as measured by the G8 frailty score
Assessment of the change in frailty after supervised exercise training, evaluated by changes in the G8 frailty score.
Minimum value: 0. Maximum value: 17. Higher values indicate better outcomes for functional impairment.
Measured: Up to 12 weeks
Compliance with supervised training program
Assessment of compliance with supervised training measured as the number of supervised training sessions attended during the intervention period
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DMMR Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ismail Gögenur
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, Herlev and Gentofte Hospital, Gødstrup Hospital, Horsens Hospital, Hvidovre University Hospital, Odense University Hospital, Randers Regional Hospital, Slagelse Hospital, Vejle Hospital, Aalborg University Hospital, Aarhus University Hospital, Zealand University Hospital, University of Copenhagen
- Responsible party
- Sponsor-investigator, Ismail Gögenur, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409844
- Sponsor's protocol ID
- p-2025-19412
- Acronym
- RESET C2
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with good academic practice and requirements of scientific journals publishing the investigation results, investigation data will be transferred in pseudonymized or anonymized format, if required, after any investigation has been completed. Data sharing will be conducted in accordance with the European data protection regulations, including the Danish Data Protection Act and the General Data Protection Regulation.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)
- ClinicalTrials.gov ID
- NCT07409844
- Acronym / sponsor ID
- RESET C2 / p-2025-19412
- Conditions
- DMMR Colorectal Cancer, Colon Cancer Stage I, Colon Cancer Stage II/III, Pembrolizumab, Immunotherapy
- Keywords
- Pembrolizumab, dMMR, colon cancer, watch-and-wait, organ sparing, neoadjuvant immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Ismail GögenurUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, Herlev and Gentofte Hospital, Gødstrup Hospital, Horsens Hospital, Hvidovre University Hospital, Odense University Hospital, Randers Regional Hospital, Slagelse Hospital, Vejle Hospital, Aalborg University Hospital, Aarhus University Hospital, Zealand University Hospital, University of Copenhagen
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Organ preservation in colorectal cancer has been pioneered in rectal cancer populations, where watch-and-wait (WW) strategies emerged from total neoadjuvant therapy. RESET C2 aims to brings this same treatment paradigm to colon cancer (CC). Despite improvements in surgical outcomes for CC over time, the risk of relapse and disproportionate complications in frail patients remain core challenges. Avoidance of surgery to limit these risks is attractive from a safety perspective but WW approaches have not been validated as curative and oncologically safe in a CC population. The subgroup of patients with CC and deficient mismatch repair (dMMR) proteins are ideal candidates for investigation as they demonstrate marked sensitivity to immunotherapy, which has the capacity to induce complete responses in a substantial proportion. The question of how this can be best leveraged for maximum benefit in a real-world setting remains to be answered.
In this study, 152 eligible participants will be recruited nationwide across 13 participating sites in Denmark. Following enrolment, clinicians will assign a surgical risk category using a composite of the American society of anaesthesiology (ASA) score and Eastern Cooperative Oncology Group performance status (ECOG). This input is combined with cancer stage data to allocate patients to one of four treatment arms. Depending on allocation, participants will receive between one to three consecutive cycles of up-front 4mg/kg pembrolizumab (max. 400mg) every six weeks. This is followed by a disease re-evaluation step, involving colonoscopy and contrast CT imaging. Colonoscopy is used to determine local disease response, and cross-sectional CT is used to confirm absence of distant disease. Participants with clinical complete response (cCR) will be eligible for WW, and those with non-cCR will be offered additional pembrolizumab before a second/final re-evaluation. Any patients with cCR at the final re-evaluation will be eligible for WW and those with non-cCR will be offered surgery. Quality of life (QoL) and late effects will be captured via patient reported outcome measures (PROMs) which will be distributed after enrolment, during immunotherapy, and at designated timepoints across survivorship. A separate cohort of 250 CC patients who undergo surgery without neoadjuvant treatment will complete identical PROMs and act as a comparator group after surgical treatment. Final analysis will compare QoL and late effects in patients who are allocated to WW (cCR), with those who receive neoadjuvant treatment and proceed to surgery (non-cCR), and finally those who proceed directly to surgery (matched cohort).
Across all treatment arms, enrolled patients will be offered multi-disciplinary prehabilitation. These functional, exercise, and nutrition interventions are graded in intensity and dependent on patient frailty and disease-factors. This forms the backbone of standard-of-care nationally for colorectal cancer patients and is implemented across all participating sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low and medium surgical risk participants with stage I-II CRC | Experimental | Drug: 1 Cycle of Pembrolizumab, Drug: Additional Cycle of PembrolizumabThese participants receive 1 cycle of up-front pembrolizumab before disease re-assessment. An additional cycle may given in the case of non-complete response |
| Low and medium surgical risk participants with stage III CRC | Experimental | Drug: 2 Cycles of PembrolizumabThese participants receive 2 cycles of up-front pembrolizumab before disease re-assessment (no additional cycles are offered if non-complete response) |
| High surgical risk participants with stage I-II CRC | Active comparator | Drug: 2 Cycles of Pembrolizumab, Drug: Additional Cycle of PembrolizumabThese participants receive 2 cycles of up-front pembrolizumab before disease re-assessment. An additional cycle may given in the case of non-complete response |
| High surgical risk participants with stage III CRC | Active comparator | Drug: 3 Cycles of Pembrolizumab, Drug: Additional Cycle of PembrolizumabThese participants receive 3 cycles of up-front pembrolizumab before disease re-assessment. An additional cycle may given in the case of non-complete response |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Written informed consent
- Clinical UICC stage I-III dMMR colon carcinoma
- Indication for elective curative-intent surgery
- ECOG status 0-2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 Cycle of PembrolizumabAlso: Keytruda1 cycle of 4mg/kg (maximum of 400mg) every 6 weeks | Drug | Low and medium surgical risk participants with stage I-II CRC |
| 2 Cycles of PembrolizumabAlso: Keytruda2 Cycles of Pembrolizumab 4mg/kg (maximum of 400mg) every 6 weeks | Drug | High surgical risk participants with stage I-II CRC, Low and medium surgical risk participants with stage III CRC |
| 3 Cycles of PembrolizumabAlso: Keytruda3 Cycles of Pembrolizumab 4mg/kg (maximum of 400mg) every 6 weeks | Drug | High surgical risk participants with stage III CRC |
| Additional Cycle of PembrolizumabAn additional 4mg/kg (maximum of 400mg) cycle of pembrolizumab in the case of non-complete response | Drug | High surgical risk participants with stage I-II CRC, High surgical risk participants with stage III CRC, Low and medium surgical risk participants with stage I-II CRC |
Primary outcome
Proportion of patients with clinical complete response (cCR)
Time frame: Periprocedural
The proportion of patients achieving a clinical complete response defined as 1) the absence of residual local tumour based on predefined endoscopic criteria and 2) absence of metastatic disease on cross-sectional CT imaging. Pathological examination may be performed to support the local tumour response assessment when endoscopic findings are equivocal. These tissue specimens will be reported as per the Mandard Tumour Regression Grading system with pathologic Complete Response (pCR) defined as Mandard Tumour Regression Grade 1.
21 secondary outcomes
Overall Survival (OS)
Time frame: Up to 3 years
Disease-free survival (DFS)
Time frame: Up to 3 years
Major patholological response (MPR) in patients undergoing surgery as per Mandard TRG
Time frame: Perioperative
Adverse events related to pembrolizumab as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 1 year
Adverse events related to surgery as per Clavien-Dindo (CD) classification
Time frame: Up to 12 weeks
Adverse events related to endoscopy as per American Society for Gastrointestinal Endoscopy (ASGE) lexicon
Time frame: Periprocedural
Planned or unplanned use of hospital services
Time frame: Up to 12 weeks
Change in global health status as measured by EORTC QLQ-C30
Time frame: Up to 5 years
Change in CRC-related quality of life as measured by EORTC QLQ-CR29
Time frame: Up to 5 years
Change in bowel function as measured by CCBDS
Time frame: Up to 5 years
Change in overall daily function and care needs as measured by EQ-5D-5L
Time frame: Up to 5 years
Change in fatigue as measured by FACIT-Fatigue
Time frame: Up to 5 years
Change in fear of cancer recurrence as measured by FCRI-SF
Time frame: Up to 5 years
Change in post-operative recovery as measured by QoR-15
Time frame: Up to 5 years
Change in physical activity as measured by NPAQ-Short
Time frame: Up to 5 years
Change in physical fitness as measured by the 6-minute walk test
Time frame: Up to 12 weeks
Change in physical fitness as measured by the sit-to-stand test
Time frame: Up to 12 weeks
Change in physical fitness as measured by hand grip strength
Time frame: Up to 12 weeks
Change in physical fitness as measured by the Borg Rating of Perceived Exertion scale
Time frame: Up to 12 weeks
Change in frailty as measured by the G8 frailty score
Time frame: Up to 12 weeks
Compliance with supervised training program
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. In accordance with good academic practice and requirements of scientific journals publishing the investigation results, investigation data will be transferred in pseudonymized or anonymized format, if required, after any investigation has been completed. Data sharing will be conducted in accordance with the European data protection regulations, including the Danish Data Protection Act and the General Data Protection Regulation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1 Cycle of Pembrolizumab, 2 Cycles of Pembrolizumab and 3 Cycles of Pembrolizumab in people with DMMR Colorectal Cancer and Colon Cancer Stage I, run by Ismail Gögenur at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ismail Gögenur, Professor (+4526336426, igo@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with clinical complete response (cCR) (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.