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IL-15 Agonist

Combination Immunotherapy for Metastatic Colorectal Cancer

Phase 1 & 2
Recruiting
Led By Jason M Redman, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have received one line of systemic checkpoint inhibitor if history of advanced microsatellite instability-high [MSI-H/dMMR]) metastatic colon cancer
Age >= 18 years
Must not have
Participants who experienced immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy was recommended (per product label or consensus guidelines) or any immune-related toxicity requiring systemic corticosteroids (with the exception of endocrinopathy that is well controlled on replacement hormones)
History of organ transplant, including allogeneic stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of cycle 1 through 30 days after the last study drug administration
Awards & highlights

Summary

This trial tests 4 experimental drugs as treatment for metastatic colorectal cancer. Participants receive $500 for 2 biopsies and are monitored for up to 5 years.

Who is the study for?
Adults with metastatic colorectal cancer who've had at least one line of systemic therapy can join this trial. They must be HIV or Hepatitis C positive under control, agree to use contraception, and have lesions for biopsy. Excluded are those recently on other treatments, with certain autoimmune diseases, organ transplants, unresolved infections, or uncontrolled illnesses.
What is being tested?
The STAR15 trial is testing a combination of up to four experimental drugs (retifanlimab, TriAdeno vaccine, N-803, SX-682) against mCRC. Participants will receive these drugs through various methods including IVs and injections over two years with follow-ups extending three more years.
What are the potential side effects?
Potential side effects may include reactions at the injection site, immune system-related issues due to immunotherapy agents involved in the treatment regimen (such as inflammation), fatigue from drug interactions and general discomfort associated with biopsies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had one treatment with a checkpoint inhibitor for my advanced colon cancer.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I am breastfeeding but willing to stop from the start of the study until 6 months after it ends.
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My colorectal cancer has spread to other parts of my body.
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I am willing to have a biopsy on my accessible lesion(s).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I stopped a previous cancer treatment due to severe side effects.
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I have had an organ or stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of cycle 1 through 30 days after the last study drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of cycle 1 through 30 days after the last study drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Secondary study objectives
Disease control rate (DCR) at 6 and 12 months
Overall survival
Progression Free Survival (PFS) at 6, 12, and 24 months
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment4 Interventions
Retifanlimab + TriAdeno Vaccine + N-803 + SX-682
Group II: Arm 1Experimental Treatment3 Interventions
Retifanlimab + TriAdeno Vaccine + N-803
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-803
2021
Completed Phase 2
~30
SX-682
2020
Completed Phase 2
~20
Retifanlimab
2018
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,940 Total Patients Enrolled
Jason M Redman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
223 Total Patients Enrolled
~40 spots leftby Oct 2025
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