INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases

Nelitolimod is a classC toll-like receptor 9 (TLR9) agonist that binds to TLR9 receptors on myeloid-derived suppressor cells(MDSCs) and helps reshape the tumor microenvironment (TME) and promote antitumor immunity. Investigators hypothesize that Nelitolimod can induce antitumor immune response in CRLM when administered regionally to the liver via a TriNav Pressure Enabled Drug Delivery (PEDD) catheter without compromising surgical feasibility or patient safety. The study objective is to investigate the feasibility and safety of an innovative immunotherapeutic approach for patients with CRLM d

Trial Details

NCT ID
NCT07172282
Phase
EARLY_PHASE1
Sponsor
Northwell Health
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Nelitolimod
Locations (sample)
  • Lake Success, New York, United States|40.77066,-73.71763

Key Eligibility Criteria

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (IC…
  • Male or female adults 18 years of age or older on day of signing informed consent.
  • Radiographically confirmed metastatic adenocarcinoma to the liver from a colon or rectum primary tumor that is amenable to resection. TXNXM1+
  • Only participants with liver-limited, resectable metastatic disease are eligible for participation (ablations are allowed to achieve an R0 intentio…

For full eligibility, visit ClinicalTrials.gov.

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