Efficay of immunotherapy berfore surgery for localized dMMR colon cancer
- Conditions
- Patients with early stage (stage I-III) dMMR colon cancerMedDRA version: 21.0Level: LLTClassification code 10009951Term: Colon cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-006046-12-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 85
•Have histologically confirmed localized dMMR stage cT1N0M0 to cT4N2M0 (stage I to III) colon carcinoma.
•Have indication for elective curative intended surgery without neoadjuvant chemo-therapy.
•Be = 18 years of age on the date of signing the informed consent.
•Provide written informed consent prior to registration according to the local regula-tory requirements.
•Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Have adequate bone marrow function:
oHemoglobin = 6.2 mmol/L or = 10 g/dL
oAbsolute neutrophil count (ANC) = 1.5 × 109/L
oPlatelet count = 100 × 109/L
Have adequate kidney function:
oGlomerular filtration rate (GFR) = 60 mL/min or creatinine =1.5 X upper lim-it of normal (ULN)
Have adequate liver function:
oTotal bilirubin = 1.5 × ULN
oAlanine aminotransferase (ALT): 10–70 U/L for males and 10–45 U/L for fe-males or = 2.5 × ULN
oAlkaline phosphatase: 35–105 U/L or = 2.5 × ULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43
•Has any serious or uncontrolled medical disorder that, in the opinion of the investi-gator or treating physician, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
•Has an autoimmune disorder (except thyroiditis with replacement therapy and type I diabetes mellitus).
•Has received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody/drug specifically targeting the T-cell co-stimulation or checkpoint pathways.
•Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active chronic or acute Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA is detected).
•Has 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 autoim-mune disease.
•Has a history of allergy to study drug components or a history of severe hypersensi-tivity reaction to any monoclonal antibody
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this study is to evaluate the efficacy of neoadjuvant treatment with pembrolizumab before colonic resection in patients with early-stage (I-III) dMMR colon cancer. ;Secondary Objective: The secondary objectives include investigating the safety and tolerability of pembrolizumab administered before surgery and developing predictive biomarkers that can identify patients with a pathological complete response to pembrolizumab. ;Primary end point(s): •Number of patients with pathological complete response.;Timepoint(s) of evaluation of this end point: Evaluation after surgery with resection of the tumor.
- Secondary Outcome Measures
Name Time Method