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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04068610
Registration number
NCT04068610
Ethics application status
Date submitted
1/08/2019
Date registered
28/08/2019
Date last updated
15/11/2023
Titles & IDs
Public title
COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC
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Scientific title
A Phase Ib/II, Open-label, Multicenter Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1)
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Secondary ID [1]
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2019-000974-44
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Secondary ID [2]
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D910CC00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Microsatellite-stable Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab
Treatment: Drugs - Oleclumab
Treatment: Drugs - FOLFOX
Treatment: Drugs - Bevacizumab
Experimental: Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab - Participants in Part 1 safety run-in arm (S1) will receive intravenous (IV) infusions of FOLFOX (5-fluorouracil [5-FU]: 2400 mg/m^2 over 46-48 hours [Day 1 and 2 of every 14-day Cycle], oxaliplatin: 85 mg/m^2, folinic acid: 400 mg/m^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion will be met.
Experimental: Part 2 (C1): FOLFOX + Bevacizumab - Participants in Part 2 control 1 arm (C1) will receive IV infusions of FOLFOX (5-FU: 2400 mg/m^2 over 46-48 hours [Day 1 and 2 of every 14-day Cycle], oxaliplatin: 85 mg/m^2, folinic acid: 400 mg/m^2) in combination with IV bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion will be met.
Experimental: Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab - Participants in Part 2 experimental 1 arm (E1) will receive IV infusions of FOLFOX (5-FU: 2400 mg/m^2 over 46-48 hours [Day 1 and 2 of every 14-day Cycle], oxaliplatin: 85 mg/m^2, folinic acid: 400 mg/m^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion will be met.
Treatment: Drugs: Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Treatment: Drugs: Oleclumab
Participants will receive IV infusion of oleclumab as stated in arm description.
Treatment: Drugs: FOLFOX
Participants will receive IV infusion of FOLFOX (5-FU, oxaliplatin, and folinic acid) as stated in arm description.
Treatment: Drugs: Bevacizumab
Participants will receive IV infusion of bevacizumab as stated in arm description.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part 1
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Assessment method [1]
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An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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Timepoint [1]
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Day 1 through 90 days after the last dose of study drug (approximately 2.8 years)
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Primary outcome [2]
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Number of Participants With Dose Limiting Toxicities (DLTs) in Part 1
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Assessment method [2]
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DLT: Any study drug related Grade (G)3 or higher toxicity including: any G3/G4 immune-mediated AE, any G3/4 noninfectious pneumonitis/colitis, transaminase elevation (TE) >8x upper limit of normal (ULN) or total bilirubin (TBL) >5xULN, increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=3xULN along with TBL >=2xULN, isolated liver TE >5 but =<8xULN or isolated TBL >3 but =<5xULN that does not downgrade to G1 or less within 14 days of onset, G3 nausea/vomiting/diarrhea that does not resolve to G2 or less within 3 days of maximal supportive care (MSC), G3/4 febrile neutropenia, G3/4 neutropenia not associated with fever/systemic infection, G4 anemia, G3 anemia with clinical sequelae/requires >2 units of red blood cells transfusion, thrombocytopenia (G4 >=7 days, G3 that did not improve by at least 1 grade within 7 days, G3/4 associated with G3/higher hemorrhage).
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Timepoint [2]
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From Day 1 to 28 days after the first dose of novel oncology therapy (durvalumab and oleclumab)
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Primary outcome [3]
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Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1
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Assessment method [3]
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Number of participants with at least common terminology criteria for adverse events (CTCAE v5.0) 2-grade shift from baseline (last assessment prior to first dose) to worst toxicity grade in clinical laboratory parameters are reported. Clinical laboratory parameter analysis included hematology, clinical chemistry, coagulation, and urinalysis.
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Timepoint [3]
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Baseline (Day 1) through 90 days after the last dose of study drug (approximately 2.8 years)
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Primary outcome [4]
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Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 1
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Assessment method [4]
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Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body temperature, blood pressure, and pulse rate).
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Timepoint [4]
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Day 1 through 90 days after the last dose of study drug (approximately 2.8 years)
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Primary outcome [5]
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Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in Part 2
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Assessment method [5]
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The OR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 criteria. The CR is defined as disappearance of all target lesions (TLs) and non-target lesions (NTLs), normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesion. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. In Part 2, randomization occurred between Day -8 and the same date as dosing.
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Timepoint [5]
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Randomization through end of study (approximately 2.6 years)
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Secondary outcome [1]
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Percentage of Participants With OR Per RECIST v1.1 in Part 1
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Assessment method [1]
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The OR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1 criteria. The CR is defined as disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation.
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Timepoint [1]
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First dose (Day 1) through end of study (approximately 2.8 years)
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Secondary outcome [2]
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Best Overall Response (BOR) Per RECIST v1.1 in Part 1
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Assessment method [2]
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BOR: best response including CR, PR, stable disease (SD), progressive disease (PD), and non-evaluable (NE) among all overall responses based on application of RECIST v1.1 to investigator assessments. CR: disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. PR: at least 30% decrease in the SoD of TL (compared to baseline) and no new NTL. Confirmation of CR and PR is required after 4 weeks. PD: at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5mm, or unequivocal progression of existing NTL, or new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in at least 8 weeks from first dose of study drug. NE: either when no or only a subset of lesion measurements are made at an assessment. Number of participants with BOR are reported.
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Timepoint [2]
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First dose (Day 1) through end of study (approximately 2.8 years)
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Secondary outcome [3]
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Duration of Response (DoR) Per RECIST v1.1 in Part 1
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Assessment method [3]
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The DoR is defined as the time from the first documentation of a confirmed response (CR or PR) until the first documentation of PD or death due to any cause, whichever occurs first. The CR is defined as disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesion. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The DoR was analyzed using Kaplan-Meier method.
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Timepoint [3]
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First dose (Day 1) through end of study (approximately 2.8 years)
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Secondary outcome [4]
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Percentage of Participants With Disease Control (DC) Per RECIST v1.1 in Part 1
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Assessment method [4]
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The DC is defined as BOR of confirmed CR, confirmed PR, or stable disease (SD; maintained for = 16 weeks) per RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesion. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Participants with SD will be included in the DC if they maintain SD for >= 16 weeks from start of treatment.
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Timepoint [4]
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First dose (Day 1) through end of study (approximately 2.8 years)
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Secondary outcome [5]
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Progression-Free Survival (PFS) Per RECIST v1.1 in Part 1
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Assessment method [5]
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The PFS is defined as the time from assignment until the first documentation of PD or death due to any cause, whichever occurs first, regardless of whether the participant received subsequent anticancer therapy prior to progression. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The PFS was analyzed using the Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments. Assignment occurred between Day -3 and -1.
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Timepoint [5]
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Assignment through end of study (approximately 2.8 years)
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Secondary outcome [6]
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Percentage of Participants With PFS at 12 Months (PFS-12) Per RECIST v1.1 in Part 1
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Assessment method [6]
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The PFS is defined as the time from assignment until the first documentation of PD or death due to any cause, whichever occurs first, regardless of whether the participant received subsequent anticancer therapy prior to progression. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The PFS was analyzed using Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments. The percentage of participants progression free and alive at 12 months (PFS-12) are reported. Assignment occurred between Day -3 and -1.
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Timepoint [6]
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Assignment through 12 months
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Secondary outcome [7]
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Overall Survival (OS) Per RECIST v1.1 in Part 1
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Assessment method [7]
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The OS is defined as the time from first dose until death due to any cause. The overall survival was analyzed using the Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments.
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Timepoint [7]
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First dose (Day 1) through end of study (approximately 2.8 years)
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Secondary outcome [8]
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Number of Participants With TEAEs and TESAEs in Part 2
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Assessment method [8]
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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Timepoint [8]
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Day 1 through 90 days after the last dose of study drug (approximately 2.6 years)
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Secondary outcome [9]
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Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2
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Assessment method [9]
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Number of participants with at least CTCAE v5.0 2-grade shift from baseline (last assessment prior to first dose) to worst toxicity grade in clinical laboratory parameters are reported. Clinical laboratory parameter analysis included hematology, clinical chemistry, coagulation, and urinalysis.
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Timepoint [9]
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Baseline (Day 1) through 90 days after the last dose of study drug (approximately 2.6 years)
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Secondary outcome [10]
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Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 2
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Assessment method [10]
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Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body temperature, blood pressure, and pulse rate).
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Timepoint [10]
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Day 1 through 90 days after the last dose of study drug (approximately 2.6 years)
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Secondary outcome [11]
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BOR Per RECIST v1.1 in Part 2
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Assessment method [11]
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BOR: best response including CR, PR, SD, PD, NE among all overall responses based on application of RECIST v1.1 to investigator assessments. CR: disappearance of all TLs, NTLs, normalization of tumor marker level, any pathological lymph nodes (target, non-target) must have reduction in short axis <10 mm, no new lesions. PR: at least 30% decrease in the SoD of TL (compared to baseline) and no new NTL. Confirmation of CR, PR is required after 4 weeks. PD: at least a 20% increase in SoDs of TLs, taking as reference smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in at least 8 weeks from first dose of study drug. NE: either when no or only a subset of lesion measurements are made at an assessment. Number of participants with BOR are reported. In Part 2, randomization occurred between Day -8 and the same date as dosing.
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Timepoint [11]
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Randomization through end of study (approximately 2.6 years)
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Secondary outcome [12]
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DoR Per RECIST v1.1 in Part 2
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Assessment method [12]
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The DoR is defined as the time from the first documentation of a confirmed response (CR or PR) until the first documentation of PD or death due to any cause, whichever occurs first. The CR is defined as disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesion. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The DoR was analyzed using Kaplan-Meier method. In Part 2, randomization occurred between Day -8 and the same date as dosing.
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Timepoint [12]
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Randomization through end of study (approximately 2.6 years)
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Secondary outcome [13]
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Percentage of Participants With DC Per RECIST v1.1 in Part 2
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Assessment method [13]
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The DC is defined as BOR of confirmed CR, confirmed PR, or SD (maintained for = 16 weeks) per RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesion. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Participants with SD will be included in the DC if they maintain SD for >= 16 weeks from start of treatment. In Part 2, randomization occurred between Day -8 and the same date as dosing.
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Timepoint [13]
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Randomization through end of study (approximately 2.6 years)
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Secondary outcome [14]
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PFS Per RECIST v1.1 in Part 2
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Assessment method [14]
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The PFS is defined as the time from randomization until the first documentation of PD or death due to any cause, whichever occurs first, regardless of whether the participant received subsequent anticancer therapy prior to progression. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The PFS was analyzed using the Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments. In Part 2, randomization occurred between Day -8 and the same date as dosing.
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Timepoint [14]
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Randomization through end of study (approximately 2.6 years)
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Secondary outcome [15]
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Percentage of Participants With PFS at 12 Months (PFS-12) Per RECIST v1.1 in Part 2
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Assessment method [15]
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The PFS is defined as the time from randomization until the first documentation of PD or death due to any cause, whichever occurs first, regardless of whether the participant received subsequent anticancer therapy prior to progression. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The PFS was analyzed using Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments. The percentage of participants progression free and alive at 12 months (PFS-12) are reported. In Part 2, randomization occurred between Day -8 and the same date as dosing.
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Timepoint [15]
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Randomization through 12 months
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Secondary outcome [16]
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OS Per RECIST v1.1 in Part 2
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Assessment method [16]
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The OS is defined as the time from randomization until death due to any cause. The overall survival was analyzed using the Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments. In Part 2, randomization occurred between Day -8 and the same date as dosing.
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Timepoint [16]
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Randomization through end of study (approximately 2.6 years)
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Secondary outcome [17]
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Serum Concentrations of Durvalumab in Part 1 (S1) and Part 2 (E1)
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Assessment method [17]
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Serum concentrations of durvalumab collected over time in Part 1 (S1) and Part 2 (E1) are reported. The lower limit of quantification (LLOQ) for durvalumab was considered to be 50 ng/mL.
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Timepoint [17]
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Part 1: Pre-dose on Day 1 of Cycle 1, 3, 7, 13; Part 2 (E1): Pre-dose on Day 1 of Cycle 1, 3, 7, 13, and 27
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Secondary outcome [18]
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Serum Concentrations of Oleclumab in Part 1 (S1) and Part 2 (E1)
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Assessment method [18]
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Serum concentrations of oleclumab collected over time in Part 1 (S1) and Part 2 (E1) are reported. The LLOQ for oleclumab was considered to be 1 µg/mL.
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Timepoint [18]
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Part 1: Pre-dose on Day 1 of Cycle 1, 2, 7, and 13; Part 2 (E1): Pre-dose on Day 1 of Cycle 1, 2, 7, 13, and 27
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Secondary outcome [19]
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Serum Concentrations of Bevacizumab in Part 1 (S1)
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Assessment method [19]
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Serum concentrations of bevacizumab collected over time in Part 1 (S1) are reported. The LLOQ for bevacizumab was considered to be 500 ng/mL.
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Timepoint [19]
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Pre-dose on Day 1 of Cycle 1, 2, 7, 13, and 27
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Secondary outcome [20]
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Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab in Part 1 (S1) and Part 2 (E1)
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Assessment method [20]
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Number of participants with positive ADA to durvalumab in Part 1 (S1) and Part 2 (E1) are reported.
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Timepoint [20]
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Part 1: Pre-dose on Day(D)1 of Cycles(C)1 (baseline [BL]), 3, 7, 13, and 90 days post last dose of study drug (approximately 2.8 years); Part 2(E1):Pre-dose on D1 of C1 (BL), 3, 7, 13, 27, and 90 days post last dose of study drug (approximately 2.6 years)
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Secondary outcome [21]
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Number of Participants With Positive ADA to Oleclumab in Part 1 (S1) and Part 2 (E1)
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Assessment method [21]
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Number of participants with positive ADA to oleclumab in Part 1 (S1) and Part 2 (E1) are reported.
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Timepoint [21]
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Part 1: Pre-dose on D1 of C1 (BL), 2, 7, 13, and 90 days post last dose of study drug (approximately 2.8 years); Part 2 (E1): Pre-dose on D1 of C1 (BL), 2, 7, 13, 27, and 90 days post last dose of study drug (approximately 2.6 years)
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Secondary outcome [22]
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Number of Participants With Positive ADA to Bevacizumab in Part 1 (S1)
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Assessment method [22]
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Number of participants with positive ADA to bevacizumab in Part 1 (S1) are reported.
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Timepoint [22]
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Pre-dose on D1 of C1 (BL), 2, 7, 13, 27, and 90 days post last dose of study drug (approximately 2.8 years)
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Eligibility
Key inclusion criteria
1. Written informed consent and any locally required authorization obtained from the
participant/legal representative prior to performing any protocol-related procedures,
including screening evaluations.
2. Age = 18 years at the time of screening.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Participants must have histologic documentation of advanced or metastatic CRC and: (a)
A documented mutation test during screening and confirmed tumor locations from disease
assessment for enrollment. (b) Participants must NOT have defective deoxyribonucleic
acid (DNA) mismatch repair (MSI) as documented by testing. (c) Participants must not
have received any prior systemic therapy for recurrent/metastatic disease (prior
adjuvant chemotherapy or radio-chemotherapy is acceptable so long as progression was
not within 6 months of completing the adjuvant regimen).
5. Participants must have at least one lesion that is measurable by RECIST v1.1
(Eisenhauer et al, 2009).
6. Participants must have adequate organ function.
7. Participants with medical conditions requiring systemic anticoagulation (eg, atrial
fibrillation) are eligible provided that both of the following criteria are met: - The
participant has an in-range International Normalized Ratio (INR) on a stable dose of
oral anticoagulant or be on a stable dose of low molecular weight heparin. - The
participant has no active bleeding or pathological condition that carries a high risk
of bleeding.
8. Body weight >35 kg.
9. Adequate method of contraception per protocol.
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Minimum age
18
Years
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Maximum age
101
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History of allogeneic organ transplantation.
2. Active or prior documented autoimmune disorders within the past 5 years.
3. History of venous thrombosis within the past 3 months.
4. Cardiovascular criteria: (a) Presence of acute coronary syndrome including myocardial
infarction or unstable angina pectoris, other arterial thrombotic event including
cerebrovascular accident or transient ischemic attack or stroke within the past 6
months. (b) New York Heart Association (NYHA) class II or greater congestive heart
failure, serious cardiac arrhythmia requiring medication, or uncontrolled
hypertension. (c) History of hypertensive crisis/hypertensive encephalopathy within
the past 6 months.
5. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) = 470 ms.
6. No significant history of bleeding events or gastrointestinal perforation.
7. Uncontrolled intercurrent illness.
8. History of another primary malignancy except for: (a) Malignancy treated with curative
intent and with no known active disease = 5 years of low potential risk for
recurrence. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without
evidence of disease. (c) Adequately treated carcinoma in situ without evidence of
disease.
9. History of active primary immunodeficiency.
10. Active infection including tuberculosis, hepatitis B, hepatitis C, or human
immunodeficiency virus.
11. Known allergy or hypersensitivity to any of the study drugs or any of the study drug
excipients.
12. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria
for Adverse Events (CTCAE) Grade > 1 from previous anticancer therapy.
13. History of leptomeningeal disease or cord compression.
14. Untreated central nervous system (CNS) metastases.
15. Lack of physical integrity of the upper gastrointestinal tract, malabsorption
syndrome, or inability to take oral medication.
16. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
17. Prior immunotherapy or anti-angiogenics.
18. Receipt of live attenuated vaccine within the past 30 days.
19. Major surgical procedure, open biopsy, or significant traumatic injury within the past
28 days.
20. Current or prior use of immunosuppressive medication within the past 14 days, with
exceptions per protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/09/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/10/2022
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Sample size
Target
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Accrual to date
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Final
61
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Clayton
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Recruitment hospital [2]
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Research Site - Heidelberg
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Recruitment hospital [3]
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Research Site - Melbourne
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Michigan
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Nevada
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Country [4]
0
0
United States of America
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State/province [4]
0
0
New York
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Country [5]
0
0
United States of America
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State/province [5]
0
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Ohio
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Country [6]
0
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United States of America
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State/province [6]
0
0
Rhode Island
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Country [7]
0
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United States of America
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State/province [7]
0
0
Tennessee
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Country [8]
0
0
United States of America
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State/province [8]
0
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Texas
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Country [9]
0
0
United States of America
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State/province [9]
0
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Virginia
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Country [10]
0
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Canada
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State/province [10]
0
0
Ontario
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Country [11]
0
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France
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State/province [11]
0
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Nantes
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Country [12]
0
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France
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State/province [12]
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Villejuif
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Country [13]
0
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Spain
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State/province [13]
0
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Barcelona
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Country [14]
0
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Spain
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State/province [14]
0
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MedImmune LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of
care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in
first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04068610
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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0
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Phone
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0
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Fax
0
0
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04068610
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