Actively Recruiting
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)
Led by National Cancer Institute (NCI) · Updated on 2026-05-01
60
Participants Needed
1
Research Sites
344 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with confirmed colorectal cancer and evidence of metastatic disease
- Participants who have received, are ineligible for, or have refused two lines of standard systemic therapy, including specific chemotherapy and targeted agents
- Participants must be 18 years or older
- Measurable disease according to RECIST 1.1 criteria
- ECOG performance status of 0 to 2
- Adequate organ and marrow function as defined by blood count and liver/kidney tests
- Recovery from prior anti-cancer therapy toxicities to Grade 1 or 2 if managed
- Participants with treated brain metastases without progression
- HIV-positive participants on stable anti-retroviral therapy with controlled viral load and adequate CD4 count
- Hepatitis C virus-positive participants who have completed antiviral therapy with undetectable viral load
- Agreement to use effective contraception for those of child-bearing potential or those who can father children
- Willingness to stop breastfeeding during treatment and follow-up
- Ability to undergo mandatory tumor biopsies
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior investigational drug, chemotherapy, immunotherapy, or therapeutic radiotherapy within 14 days before starting treatment
- Palliative radiotherapy within 7 days before starting treatment
- Active autoimmune disease requiring systemic immunosuppression above physiologic doses, with specific exceptions
- Evidence or history of interstitial lung disease or active noninfectious pneumonitis, except asymptomatic chronic radiation changes
- Active infections needing systemic antibiotics, antifungal, or antiviral treatment within 8 days before treatment
- History of organ transplantation
- Previous immune-related toxicity from checkpoint inhibitors requiring permanent discontinuation or systemic corticosteroids, except controlled endocrinopathies
- Allergic reactions to similar compounds as study drugs
- Receipt of live vaccines within 28 days before treatment
- Hepatitis B infection unless on suppressive therapy, except resolved prior infection
- Pregnancy confirmed by pregnancy test
- Uncontrolled illnesses limiting study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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