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 (Sep 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
Treatments studied
Immunotherapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Allowed: MSH2 loss
history of advanced microsatellite instability-high [MSI-H/dMMR] metastatic colon cancer
Allowed: MSH6 loss
history of advanced microsatellite instability-high [MSI-H/dMMR] metastatic colon cancer
Allowed: MLH1 loss
history of advanced microsatellite instability-high [MSI-H/dMMR] metastatic colon cancer
Allowed: PMS2 loss
history of advanced microsatellite instability-high [MSI-H/dMMR] metastatic colon cancer
Allowed: RAS wild-type
if history of RAS wild-type EGFR-targeted therapy
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: systemic therapy (fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, regorafenib, trifluridine) — metastatic colorectal cancer
Participants 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
Must have received: EGFR-targeted therapy — metastatic colorectal cancer (if history of RAS wild-type)
if history of RAS wild-type EGFR-targeted therapy
Must have received: checkpoint inhibitor — advanced MSI-H/dMMR metastatic colon cancer
Participants must have received one line of systemic checkpoint inhibitor if history of advanced microsatellite instability-high [MSI-H/dMMR] metastatic colon cancer
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) calculated by Cockroft-Gault formula >= 50 mL/min
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: ANC >= 1,500 cells/mm^3; platelet count >= 100,000 cells/mm^3; hemoglobin >= 9 g/dL; 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; 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06149481 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy and EGFR-targeted therapy.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages