{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T05:45:56Z","timestamp":1772343956303,"version":"3.50.1"},"reference-count":31,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2021,12,14]],"date-time":"2021-12-14T00:00:00Z","timestamp":1639440000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Oncol."],"abstract":"<jats:p>The NIVACOR trial is a phase II study assessing the efficacy and safety of nivolumab in combination with FOLFOXIRI\/bevacizumab in first-line setting in patients affected by metastatic colorectal cancer (mCRC) RAS\/BRAF mutated. We report safety run-in results in the first 10 patients enrolled. Patients received triplet chemotherapy with FOLFOXIRI scheme plus bevacizumab, in association with nivolumab every 2 weeks for 8 cycles (induction phase) followed by bevacizumab plus nivolumab every 2 weeks (maintenance phase), until progression of disease or unacceptable toxicities. The first ten patients were evaluated: 7 experienced at least one adverse event (AE) related to FOLFOXIRI\/bevacizumab and 2 related to nivolumab. The most frequent grade 1\u20132 AEs related to FOLFOXIRI\/bevacizumab were diarrhea and fatigue (71%), nausea and vomiting (57%); 3 (43%) had grade 3\u20134 neutropenia, and 2 (20%) patients developed grade 1\u20132 AEs nivolumab related: skin rash and salivary gland infection. Two patients delayed the dose because of serious AEs, proteinuria and salivary gland infection; one patient discontinued experimental treatment due to the ileo-urethral fistula and concurrent <jats:italic>Clostridium<\/jats:italic> infection diarrhea. No treatment- related death occurred. The safety run-in analysis of NIVACOR trial reassured using co-administration of FOLFOXIRI\/bevacizumab and nivolumab was well tolerated with an acceptable toxicity profile.<\/jats:p><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p><jats:uri>https:\/\/clinicaltrials.gov\/<\/jats:uri>, (NCT04072198).<\/jats:p><\/jats:sec>","DOI":"10.3389\/fonc.2021.766500","type":"journal-article","created":{"date-parts":[[2021,12,14]],"date-time":"2021-12-14T11:55:48Z","timestamp":1639482948000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":19,"title":["FOLFOXIRI\/Bevacizumab Plus Nivolumab as First-Line Treatment in Metastatic Colorectal Cancer RAS\/BRAF Mutated: Safety Run-In of Phase II NIVACOR 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