{"entity":{"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","aka":[],"tldr":"Published report from the COLUMBIA-1 trial registered as NCT04068610, in British Journal of Cancer (2024), chosen as the most cited paper whose own text cites the registry id.","summary":"Background: To determine whether the addition of durvalumab (anti-PD-L1) and oleclumab (anti-CD73) to standard-of-care treatment (FOLFOX and bevacizumab) enhances the anti-tumour effect in patients with metastatic colorectal cancer (mCRC).\n\nMethods: COLUMBIA-1 (NCT04068610) was a Phase Ib (feasibility; Part 1)/Phase II (randomised; Part 2) trial in patients with treatment-naïve microsatellite stable mCRC. Patients in Part 2 were randomised to receive standard-of-care (control arm) or standard-of-care plus durvalumab and oleclumab (experimental arm). Primary objectives included safety and efficacy.\n\nResults: Seven patients were enrolled in Part 1 and 52 in Part 2 (n = 26 in each arm). Grade ≥3 treatment-emergent adverse events (TEAE) occurred in 80.8% and 65.4% of patients in the control and experimental arms of Part 2, respectively, with 26.9% and 46.3% experiencing serious TEAEs. The confirmed objective response rate (ORR) was numerically higher in the experimental arm compared with the control arm (61.5% [95% confidence interval (CI), 40.6-79.8] vs 46.2% [95% CI, 26.6-66.6]) but did not meet the statistically significant threshold in either arm.\n\nConclusion: The safety profile of FOLFOX and bevacizumab in combination with durvalumab and oleclumab was manageable; however, the efficacy results do not warrant further development of this combination in patients with microsatellite stable mCRC.\n\nRegistration: NCT04068610.\n\nIndexed on Europe PMC as PubMed record 39048638 (DOI 10.1038/s41416-024-02796-3). Its abstract cites the registry id NCT04068610, which is how it was matched to this trial; no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"Br J Cancer 2024","url":"https://doi.org/10.1038/s41416-024-02796-3"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/39048638/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/39048638"},{"label":"ClinicalTrials.gov NCT04068610","url":"https://clinicaltrials.gov/study/NCT04068610"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct04068610"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["british-journal-of-cancer"],"dependsOn":[],"notes":[],"journal":"British Journal of Cancer","year":2024,"doi":"10.1038/s41416-024-02796-3","pmid":"39048638","authors":"Segal NH, Tie J, Kopetz S, et al.","paperType":"rct","findings":[],"whatItMeans":"This is the paper Europe PMC returns for registry id NCT04068610 with the most citations, so it is the natural first reading for anyone following the COLUMBIA-1 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.","caveats":["Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper."]},"route":"/key-papers/paper-nct04068610-br-j-cancer-2024/","neighbours":{"trial":[{"id":"nct04068610","kind":"trial","name":"COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC","route":"/trials/nct04068610/"}],"journal":[{"id":"british-journal-of-cancer","kind":"journal","name":"British Journal of Cancer","route":"/journals/british-journal-of-cancer/"}]}}