OncoMatch/Clinical Trials/NCT06149481
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 NCT06149481 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform and Retifanlimab for metastatic colorectal cancer.
Treatment: Retifanlimab · Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform · N-803 · SX-682 — Background: Each year, more than 32,000 people in the United States are diagnosed with colorectal cancer that has returned or progressed after treatment and spread to other organs. This is called metastatic colorectal cancer (mCRC). Most people with mCRC survive only about 2 years. Objective: To test the ability of a combination of up to 4 experimental anti-cancer drugs treat mCRC. The names of these drugs are retifanlimab, TriAdeno vaccine, N-803, and SX-682. They are described below. Eligibility: Adults aged 18 years or older with mCRC. Participants must have Design: Participants will be screened. This includes having a physical exam, blood tests, urine tests, and imaging tests. If signed on to the study, participants will have 2 tumor biopsies. One when starting the study and once about 8 weeks after bring on the study. Participants will receive $500 for each biopsy. Participants will be treated with either 3 or 4 drugs and will receive a detailed calendar explaining when each drug is given. Retifanlimab is given every 4 weeks through an IV (an IV is tube attached to a needle inserted into a vein in the arm). N-803 is injected under the skin on the abdomen every 4 weeks. TriAdeno vaccine is injected under the skin of the upper arm or thigh once a month for 3 doses and then once every 3 months. Some participants will also receive a 4th drug. SX-682 is a pill taken by mouth. Participants will take this drug 2 times a day at home for about 3 weeks of each month. Study treatment will continue up to 2 years. Follow-up phone calls/emails may continue for 3 more years.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
if history of RAS wild-type, EGFR-targeted therapy
Required: NRAS wild-type
if history of RAS wild-type, EGFR-targeted therapy
Required: BRAF wild-type
if history of RAS wild-type, EGFR-targeted therapy
Allowed: MMR deficient
if history of advanced microsatellite instability-high [MSI-H/dMMR] metastatic colon cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: fluoropyrimidine
must have received, been ineligible to receive, or refused to receive two lines of standard systemic therapy i.e., a fluoropyrimidine with oxaliplatin or irinotecan with bevacizumab, regorafenib, trifluridine, and (if history of RAS wild-type) EGFR-targeted therapy
Must have received: oxaliplatin
fluoropyrimidine with oxaliplatin
Must have received: irinotecan
irinotecan with bevacizumab
Must have received: bevacizumab (bevacizumab)
irinotecan with bevacizumab
Must have received: regorafenib (regorafenib)
regorafenib
Must have received: trifluridine (trifluridine)
trifluridine
Must have received: EGFR-targeted therapy
if history of RAS wild-type, EGFR-targeted therapy
Must have received: checkpoint inhibitor
must have received one line of systemic checkpoint inhibitor if history of advanced microsatellite instability-high [MSI-H/dMMR] metastatic colon cancer
Cannot have received: investigational drug
prior investigational drug, chemotherapy, immunotherapy, or any prior therapeutic radiotherapy within 14 days prior to study treatment initiation
Cannot have received: chemotherapy
prior investigational drug, chemotherapy, immunotherapy, or any prior therapeutic radiotherapy within 14 days prior to study treatment initiation
Cannot have received: immunotherapy
prior investigational drug, chemotherapy, immunotherapy, or any prior therapeutic radiotherapy within 14 days prior to study treatment initiation
Cannot have received: therapeutic radiotherapy
prior investigational drug, chemotherapy, immunotherapy, or any prior therapeutic radiotherapy within 14 days prior to study treatment initiation
Cannot have received: palliative radiotherapy
palliative radiotherapy performed within 7 days prior to study treatment initiation
Lab requirements
Blood counts
ANC >= 1,500 cells/mm^3; platelet count >= 100,000 cells/mm^3; hemoglobin >= 9 g/dL
Kidney function
creatinine clearance (CrCl) >= 50 mL/min (Cockroft-Gault)
Liver function
total bilirubin < 1.5 x ULN; ALT <= 2.5 x ULN OR <= 5 x ULN for participants with liver metastases; AST <= 2.5 x ULN OR <= 5 x ULN for participants with liver metastases
Adequate organ and marrow as a function defined below: * absolute neutrophil count (ANC) >= 1,500 cells/mm^3 * platelet count >= 100,000 cells/mm^3 * hemoglobin (Hgb) >= 9 g/dL * total bilirubin level < 1.5 x upper limit of normal (ULN) * alanine aminotransferase (ALT) <= 2.5 x ULN OR <= 5 x ULN for participants with liver metastases * aspartate aminotransferase (AST) level <= 2.5 x ULN OR <= 5 x ULN for participants with liver metastases * creatinine clearance (CrCl) calculated by Cockroft-Gault formula >= 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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