Columbia 2 is a Phase 2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX) alone and in combination with novel oncology therapies in adjuvant high-risk microsatellite-stable colorectal cancer
Columbia 2 is a Phase 2, open-label, randomized, multicenter, platform study of novel oncology therapies in combination with adjuvant chemotherapy in patients with high-risk microsatellite-stable colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle).
Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle). Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle)
ctDNA clearance
ctDNA clearance is defined as the change from ctDNA positive status at baseline to ctDNA negative post baseline (6 months)
Time frame: From the time of first dose to 6 months post treatment
Incidence of adverse events
The secondary endpoint of safety as assessed by the number of subjects with adverse events and serious adverse events
Time frame: From time of first dose to 90 days post last dose
Disease free survival
From randomization until time of first documented incidence of disease recurrence, secondary cancer, or death due to any cause, whichever occurs first
Time frame: From time of first dose till end of study (5 years)
Disease free survival at 12 months
Percentage of subject who are disease free at 12 months post first dose of treatment
Time frame: From time of first dose till end of study (5 years)
overall survival
From randomization until death due to any cause
Time frame: From time of first dose till end of study (5 years)
Serum conenctration levels of novel agents in combination with mFOLFOX6
Pharmacokinetics of novel agents in combination with FOLFOX
Time frame: From Day 1 up to 90 days post last dose
Number of subjects with detectable anti-drug antibody (ADA) to novel agents in combination with mFOLFOX6
Immunogenicity of novel agents in combination with mFOLFOX6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle). Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) Oleclumab 3,000 mg IV Q2W x5 then Q4W (Day 1 of every 14-day cycle through cycle 4 then Day 1 of every other 14-day cycle)
Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle). Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) Monalizumab 750 mg IV, Q2W (Day 1 of every 14-day cycle)
Time frame: From Day 1 up to 90 days post last dose