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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Retifanlimab

2018

Completed Phase 2

~320

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,381 Total Patients Enrolled

Jason M Redman, M.D.Principal InvestigatorNational Cancer Institute (NCI)

4 Previous Clinical Trials

223 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria for participating in this trial?

"This clinical trial requires that individuals with colorectal cancer, aged between 18 and 120 years old, apply. The research team is hoping to enlist about 50 people for this study."

Answered by AI

Is this investigation enrolling participants who are 40 years or older?

"This research is looking for individuals who are of 18 years or above, and not exceeding 120 years in age."

Answered by AI

What are the objectives of this research endeavor?

"The primary outcome of the study, measured between Day 1 Cycle 1 and 30 days after last drug administration will be overall response rate (ORR) to the IO regimen in metastatic colorectal cancer. Secondary objectives include assessment of safety with AEs reported by type and grade within Phase II, disease control rate (DCR) at 6 and 12 months expressed as a fraction with 95% confidence intervals for each, along with progression-free survival (PFS) determined via Kaplan-Meier method reported at 6, 12, and 24 months from enrolment date accompanied by corresponding 95% CI's."

Answered by AI

Are there vacancies available for trial participants?

"Contrary to what is posted on clinicaltrials.gov, this medical trial isn't currently recruiting candidates after being initially posted on December 4th 2023 and lastly updated November 28th 2023. Though no longer accepting participants for this experiment, there are 973 other studies actively welcoming volunteers at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2024. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06149481.