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This study will gather information on the safety and effectiveness of pembrolizumab, an immunotherapy drug. The purpose of this study is to target early stage colon cancer before it has developed resistance to immunotherapy.
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Inclusion criteria
Patients must have histologically confirmed colon adenocarcinoma.
No prior chemotherapy, targeted therapy, or immunotherapy for colon cancer.
Deemed to have surgically resectable disease.
Archival tissue block containing colon adenocarcinoma must be confirmed available prior to enrollment. MSI testing should be obtained prior to starting therapy.
Be willing and able to provide written informed consent/assent for the trial.
Be 18 years of age or older on day of signing informed consent.
Have a measurable primary lesion by lower endoscopy or CT-imaging with a diameter of 1 or more centimeters.
Have a performance status of 0 or 1 on the ECOG Performance Scale.
Have no histologically confirmed disseminated disease by CT or PET-CT staging.
Male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
Demonstrate adequate organ function as defined below. All screening labs should be performed within 14 days of treatment initiation.
Adequate Organ Function Laboratory Values
Absolute neutrophil count (ANC) - ≥1500/µL
Platelets - ≥100 000/µL
Hemoglobin - ≥7.0 g/dL or ≥5.6 mmol/La
Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) - ≤1.5 × ULN OR
30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Total bilirubin - ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
AST (SGOT) and ALT (SGPT) - ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
International normalized ratio (INR) OR prothrombin time (PT)/ Activated partial thromboplastin time (aPTT) - ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
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Central trial contact
Daniel Catenacci, MD
Data sourced from clinicaltrials.gov
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