Article ; Online: 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.
2023 Volume 13, Issue 6, Page(s) e073372
Abstract: Introduction: Within the last two decades, major advances have been made in the surgical approach for patients with colorectal cancer. However, to this day we face considerable challenges in reducing surgery-related complications and improving long-term ...
| Abstract | Introduction: Within the last two decades, major advances have been made in the surgical approach for patients with colorectal cancer. However, to this day we face considerable challenges in reducing surgery-related complications and improving long-term oncological outcomes. Unprecedented response rates have been achieved in studies investigating immunotherapy in patients with mismatch repair deficient (dMMR) colorectal cancer. This has raised the question of whether neoadjuvant immunotherapy may change the standard of care for localised dMMR colon cancer and pave the way for organ-sparing treatment. Methods and analysis: This is an investigator-initiated, multicentre, prospective, single-arm, phase II study in patients with stage I-III dMMR colon cancer scheduled for intended curative surgery. Eighty-five patients will be treated with one dose of pembrolizumab (4 mg/kg) and within 5 weeks will undergo a re-evaluation with an endoscopy and a CT scan-to assess tumour response-before standard resection of the tumour. The primary endpoint is the number of patients with pathological complete response, and secondary endpoints include safety (number and severity of adverse events) and postoperative surgical complications. In addition, we aspire to identify predictive biomarkers that can point out patients that achieve pathological complete response. Ethics and dissemination: The Regional Committee for Health Research and Ethics and the Danish Medicines Agency have approved this study. The study will be performed according to the Helsinki II declaration. Written informed consent will be obtained from all participants. The results of the study will be submitted to peer-reviewed journals for publication and presented at international congresses. Trial registration number: NCT05662527. |
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| MeSH term(s) | Humans ; Neoadjuvant Therapy/methods ; Prospective Studies ; Colonic Neoplasms/drug therapy ; Colonic Neoplasms/surgery ; Colorectal Neoplasms ; Clinical Trials, Phase II as Topic ; Multicenter Studies as Topic |
| Chemical Substances | pembrolizumab (DPT0O3T46P) |
| Language | English |
| Publishing date | 2023-06-22 |
| Publishing country | England |
| Document type | Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 2599832-8 |
| ISSN | 2044-6055 ; 2044-6055 |
| ISSN (online) | 2044-6055 |
| ISSN | 2044-6055 |
| DOI | 10.1136/bmjopen-2023-073372 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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