COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Lā¦ (NCT04068610) | Clinical Trial Compass
Active ā Not RecruitingPhase 1/2
COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC
United States61 participantsStarted 2019-09-13
Plain-language 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).
Who can participate
Age range18 Years ā 101 Years
SexALL
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Inclusion criteria
ā. Written informed consent and any locally required authorization obtained from the participant/legal representative prior to performing any protocol-related procedures, including screening evaluations.
ā. Age ā„ 18 years at the time of screening.
ā. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
ā. 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).
ā. Participants must have at least one lesion that is measurable by RECIST v1.1 (Eisenhauer et al, 2009).
ā. Participants must have adequate organ function.
ā. 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.
ā. Body weight \>35 kg.
Exclusion criteria
ā
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part 1
Timeframe: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years)
2
Number of Participants With Dose Limiting Toxicities (DLTs) in Part 1
Timeframe: From Day 1 to 28 days after the first dose of novel oncology therapy (durvalumab and oleclumab)
3
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1
Timeframe: Baseline (Day 1) through 90 days after the last dose of study drug (approximately 2.8 years)
4
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 1
Timeframe: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years)
5
Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in Part 2
Timeframe: Randomization through end of study (approximately 2.6 years)
ā. Active or prior documented autoimmune disorders within the past 5 years.
ā. History of venous thrombosis within the past 3 months.
ā. 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.
ā. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ā„ 470 ms.
ā. No significant history of bleeding events or gastrointestinal perforation.
ā. Uncontrolled intercurrent illness.
ā. History of another primary malignancy except for: (a) Malignancy treated with curative intent and with no known active disease ā„ 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.