{"entity":{"id":"nct04068610","kind":"trial","name":"COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC","aka":["COLUMBIA-1"],"tldr":"A phase 1/2 trial of Durvalumab, Oleclumab, FOLFOX in colorectal cancer, run by MedImmune LLC, active and no longer recruiting.","summary":"COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC is a phase 1/2 interventional study registered as NCT04068610 by MedImmune LLC, with 61 participants enrolled, started 2019-09-13 and due to reach its primary completion in 2022-10-10. Interventions recorded: Durvalumab, Oleclumab, FOLFOX, Bevacizumab. Conditions listed: Metastatic Microsatellite-stable Colorectal Cancer. Results were posted on ClinicalTrials.gov in 2023; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04068610","url":"https://clinicaltrials.gov/study/NCT04068610"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","monoclonal-antibody"],"targets":[],"drugs":["durvalumab","oleclumab","folfox","bevacizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04068610-br-j-cancer-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04068610","phase":"1/2","setting":"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)","sponsor":"MedImmune LLC","started":"2019-09-13","startedType":"actual","yearReported":2023,"enrolled":61,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in Part 2","primary":true,"unit":"%","arms":[{"name":"Part 2 (C1): FOLFOX + Bevacizumab","n":26,"value":46.2,"note":"95% CI 26.6 to 66.6; Figures from the ClinicalTrials.gov results section (first posted 2023-11-15), not from a publication"},{"name":"Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab","n":26,"value":61.5,"note":"95% CI 40.6 to 79.8"}],"p":"0.3173","source":"https://clinicaltrials.gov/study/NCT04068610?tab=results"},{"endpoint":"Overall Survival (OS) Per RECIST v1.1 in Part 1","unit":"months","arms":[{"name":"Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab","n":7,"value":30.1,"note":"95% CI 11.9 to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-11-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04068610?tab=results"},{"endpoint":"Progression-Free Survival (PFS) Per RECIST v1.1 in Part 1","unit":"months","arms":[{"name":"Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab","n":7,"value":9.5,"note":"95% CI 7.8 to 18.2; Figures from the ClinicalTrials.gov results section (first posted 2023-11-15), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04068610?tab=results"}]},"route":"/trials/nct04068610/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"drug":[{"id":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"oleclumab","kind":"drug","name":"Oleclumab","route":"/drugs/oleclumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"paper":[{"id":"paper-nct04068610-br-j-cancer-2024","kind":"paper","name":"COLUMBIA-1: a randomised study of durvalumab plus oleclumab in combination with chemotherapy and bevacizumab in metastatic microsatellite-stable colorectal cancer","route":"/key-papers/paper-nct04068610-br-j-cancer-2024/"}]}}