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Colon CancerPhase 2RESET-CNCT05662527

Response to Immunotherapy in MMR-deficient Localized Colon Cancer

A Phase 2 study testing Pembrolizumab in people with Colon Cancer, run by Camilla Qvortrup at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the safety and efficacy of neoadjuvant treatment with pembrolizumab before colonic resection in patients with early-stage (I-III) deficient mismatch repair (dMMR) colon cancer (CC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer
What is being tested?
Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteDenmark
Study dates
22 Feb 2023to 6 Jun 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologically confirmed localized dMMR stage cT1N0M0 to cT4N2M0 (stage I to III) colon carcinoma.
  • Indication for elective curative intended surgery without neoadjuvant chemotherapy.
  • Age of ≥ 18 years.
  • Written informed consent.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Adequate bone marrow function defined as:
Show all 20Show fewer
  • Hemoglobin ≥ 6.2 mmol/L or ≥ 10 g/dL.
  • Absolute neutrophil count ≥ 1.5 × 109/L.
  • Platelet count ≥ 100 × 109/L.
  • Adequate kidney function defined as:
  • o Estimated glomerular filtration rate ≥ 60 mL/min or creatinine ≤1.5 × upper limit of normal (ULN).
  • Adequate liver function defined as:
  • Total bilirubin: ≤ 1.5 × ULN.
  • Alanine aminotransferase: ≤ 2.5 × ULN.
  • Alkaline phosphatase: ≤ 2.5 × ULN.
  • Follow the conditions regarding fertility, pregnancy, and lactation:
  • Female and male participants of reproductive potential (PORP) must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving pembrolizumab and for 120 days after the dose.
  • PORPs must use, or have their partner use, an acceptable method of contraception e.g. intrauterine device, contraceptive rod implanted into the skin, or hormonal contraceptive and male condom during heterosexual activity, while receiving pembrolizumab and for 120 days after the dose.
  • Women of reproductive potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L HCG) within 72 hours prior to receiving pembrolizumab.
  • Women must not be breastfeeding.

Who cannot join

  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator or treating physician, may increase the risk associated with study participation, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
  • Autoimmune disorders (except thyroiditis with replacement therapy and type I diabetes mellitus).
  • Prior treatment with ICIs or any other antibody/drug specifically targeting the T-cell co-stimulation or checkpoint pathways.
  • A known history of Human Immunodeficiency Virus, active chronic, or acute Hepatitis B or Hepatitis C.
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Prior participation in another trial with an investigational medicinal product.
  • Received live vaccines within 30 days prior to pembrolizumab trial treatment. Seasonal influenza vaccines for injection are allowed.
  • A history of allergy to study drug components or a history of severe hypersensitivity reaction to any monoclonal antibody.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Zealand University Hospital

    Roskilde

Other trials in Denmark

About this study

Official title: Efficacy of Immunotherapy in Patients With MMR-deficient Localized Colon Cancer Scheduled for Curative Surgery - A Prospective, Phase II Study

The aim of this study is to evaluate the safety and efficacy of neoadjuvant treatment with pembrolizumab before colonic resection in patients with early-stage (I-III) deficient mismatch repair (dMMR) colon cancer (CC).

Read the detailed description

The trial is designed as an investigator-initiated, multicenter, prospective, single arm phase II study in patients with stage I-III dMMR CC scheduled for intended curative surgery to determine the efficacy of immunotherapy using pembrolizumab in the neoadjuvant setting. Patients will receive one dose of pembrolizumab (dosage of 4mg/kg, maximum of 400mg) following diagnosis. After 3 weeks a re-evaluation (to assess tumor response) will be performed, followed by standard surgery for resection of the tumor. Surgery will therefore be performed within 3 to 5 weeks after the dose of pembrolizumab treatment. Following the surgical resection the patients may receive post-operative chemotherapy in accordance with the clinical decision. The patients will be followed as per the standard Danish guidelines with CT scans at 1 and 3 years after surgery.

Conditions
Colon Cancer
Being tested
Pembrolizumab
Keywords
Localized colon cancer, dMMR, Immunotherapy, Biomarkers
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called Keytruda

    One dosage of 4mg/kg (maximum of 400mg)

Study groups in NCT05662527
Study groupRoleWhat they receive
Neoadjuvant pembrolizumabExperimentalPembrolizumab
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response (pCR)

    Number of patients with pCR evaluated according to the Mandard tumour regression grading system

    Measured: Tumour specimen evaluated within 2 weeks after surgery.

Secondary outcomes (5)

  1. Safety and tolerability of pembrolizumab administered before surgery

    Determined by the incidence and severity of treatment related adverse events according to CTCAE version 5.0

    Measured: Up to approximately 9 weeks

  2. Postoperative surgical complications

    Number and severity of postoperative surgical complications determined by Clavien-Dindo classification system.

    Measured: Before and up to 4 weeks after surgery

  3. Immunohistochemistry analysis of markers including CD3, CD8, and PD-L1

    Assessment of potential predictive biomarker by investigating immunological markers across pre- and post-treatment biopsies and sequential blood samples.

    Measured: Baseline compared to the surgical specimen at 3-5 weeks

  4. Methylated circulating cell-free DNA

    Treatment response evaluated by methylated circulating cell-free DNA (cfDNA) specific for CC analysed across sequential blood samples using the TriMeth test

    Measured: Up to approximately 9 weeks

  5. Gene expression by mRNA

    To quantify the expression of genes central to the tumour microenvironment and immune evasion of cancer among others

    Measured: Baseline compared to the surgical specimen at 3-5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2022
  2. Study start22 Feb 2023
  3. Primary completion6 Jun 2024
  4. Study completion6 Jun 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05662527
Sponsor's protocol ID
011121
Acronym
RESET-C
Status last verified
Aug 2024
First submitted
24 Nov 2022
Last updated
13 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: In accordance with good academic practice, the study data (health data and genomic data) is planned to be transferred in anonymized form to the secure database European Genome-Phenome Archive (EGA). This will happen after the study has been completed. The purpose is to enable sharing of the data with other research groups for future research, inside and outside of Denmark. In all cases, data access decisions will be made by the study protocol committee. 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. The EGA is part of the European ELIXIR research infrastructure, which is partly funded by the European Commission.

Publications

  • Gogenur I, Justesen TF, Tarpgaard LS, Bulut M, Hansen TF, Jensen LH, Rahr HB, Gogenur M, Kirkegaard T, Balsevicius L, Chieng M, Raskov H, Sorensen MKS, Petersen PC, Eriksen JR, Salomon S, Fiehn AK, Mikkelsen MD, Brandsborg S, Gotschalck KA, Emmertsen KJ, Ramlov A, Born PW, Thorlacius-Ussing O, Lauritzen MB, Olesen RK, Poulsen LO, Lykke J, Schou J, Buskov L, Krarup PM, Andersen CL, Pallisgaard N, Pfeiffer P, Qvortrup C. Neoadjuvant Single-Cycle Pembrolizumab for Stage I-III MMR-Deficient Colon Cancer: The RESET-C Trial. J Clin Oncol. 2026 Jun 20;44(18):1687-1696. doi: 10.1200/JCO-25-02274. Epub 2026 May 5.

    PubMed 42085635

  • Gogenur I, Justesen TF, Tarpgaard LS, Bulut M, Hansen TF, Jensen LH, Rahr HB, Kirkegaard T, Balsevicius L, Raskov H, Petersen PC, Eriksen JR, Salomon S, Fiehn AK, Brandsborg S, Gotschalck KA, Emmertsen KJ, Born PW, Thorlacius-Ussing O, Lauritzen MB, Olesen RK, Poulsen LO, Lykke J, Schou J, Buskov L, Krarup PM, Andersen CL, Pfeiffer P, Qvortrup C. Neoadjuvant Pembrolizumab in Stages I-III Deficient Mismatch Repair Colon Cancer: A Clinical Trial. Ann Surg. 2026 Jun 1;283(6):1075-1081. doi: 10.1097/SLA.0000000000006611. Epub 2024 Dec 18.

    PubMed 39692004

  • Justesen TF, Gogenur I, Tarpgaard LS, Pfeiffer P, Qvortrup C. Evaluating the efficacy and safety of neoadjuvant pembrolizumab in patients with stage I-III MMR-deficient colon cancer: a national, multicentre, prospective, single-arm, phase II study protocol. BMJ Open. 2023 Jun 22;13(6):e073372. doi: 10.1136/bmjopen-2023-073372.

    PubMed 37349100

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Colon Cancer, run by Camilla Qvortrup 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 20 inclusion and 8 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: finished, as of the sponsor's last update on 13 Aug 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) (time frame: Tumour specimen evaluated within 2 weeks after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05662527, which also lists 3 linked publications.

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 13 Aug 2024.

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