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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of cycle 1 through 30 days after the last study drug administration

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

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