{"entity":{"id":"nct06149481","kind":"trial","name":"Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Can","aka":[],"tldr":"A phase 1/2 trial of retifanlimab and nogapendekin alfa inbakicept in colorectal cancer, run by National Cancer Institute (NCI), now recruiting.","summary":"Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC) is a phase 1/2, interventional study registered as NCT06149481 by National Cancer Institute (NCI), with a registry enrolment figure of 60 participants, started 2024-03-26 and due to reach its primary completion in 2027-10-31. Interventions recorded: Retifanlimab; Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform; N-803; SX-682. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Phase I: Safety profiles of the IO regimens consisting of retifanlimab, TriAdeno vaccine, N-803 (A1), and retifanlimab, TriAdeno vaccine, N-803, SX-682 (A2) in participants with metastatic colorectal cancer; Phase II: Overall response rate (ORR) defined as the CR+PR of the IO regimen in mCRC. Colorectal eligibility wording from the registry: \"* Participants with histologically confirmed colorectal cancer and evidence of metastatic disease\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT06149481","url":"https://clinicaltrials.gov/study/NCT06149481"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","shared-antigen-vaccine"],"targets":[],"drugs":["retifanlimab","nogapendekin-alfa"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06149481","phase":"1/2","setting":"Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)","sponsor":"National Cancer Institute (NCI)","enrolled":60,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06149481/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"shared-antigen-vaccine","kind":"technology","name":"Off-the-shelf cancer vaccines","route":"/technologies/shared-antigen-vaccine/"}],"drug":[{"id":"nogapendekin-alfa","kind":"drug","name":"Nogapendekin alfa inbakicept","route":"/drugs/nogapendekin-alfa/"},{"id":"retifanlimab","kind":"drug","name":"Retifanlimab","route":"/drugs/retifanlimab/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}