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)

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

Trial Details

NCT ID
NCT06149481
Phase
PHASE1 / PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Retifanlimab
  • Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform
  • N-803
  • SX-682
Locations (sample)
  • Bethesda, Maryland, United States|38.98067,-77.10026

Key Eligibility Criteria

  • Participants with histologically confirmed colorectal cancer and evidence of metastatic disease.
  • Participants must have received, been ineligible to receive, or refused to receive two lines of standard systemic therapy i.e., a fluoropyrimidine …
  • Participants who had progressive disease within 6 months before study treatment following standard adjuvant therapy are eligible if they have not r…
  • Age \>= 18 years.

For full eligibility, visit ClinicalTrials.gov.

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