INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases
ConditionColorectal Cancer Metastatic
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health
About this trial
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 designed to overcome the immunosuppressive TME in CRLM. Investigators hypothesize that this investigational neoadjuvant treatment will be well tolerated and will not prevent patients from undergoing successful, safe CRLM liver resections. Investigators will assess the safety and feasibility of Nelitolimod given via TriNav PEDD in 10 patients with CRLM prior to liver resection. Patients will receive standard treatment with chemotherapy and then undergo placement of the PEDD catheter. Patients will then receive 3 doses of Nelitolimod before undergoing liver resection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. A signed informed consent must be obtained prior to conducting any study-specific procedures.
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 intention-to-treat outcome).
Disqualifiers
• Systemic therapy with immunosuppressive agents within 7 days or use of any investigational drug within 28 days before the start of trial treatment.
Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used as antineoplastic therapy for metastatic CRC.
Receipt of any organ transplantation, including allogeneic stem cell transplantation.
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent, such as rheumatoid arthritis, which in the opinion of the Investigator might impair the subject's tolerance or ability to participate in the trial.
Trial design
Design model
Single group
Treatments tested in this trial
Nelitolimod
DrugNelitolimod drug product is a clear to slightly opalescent, colorless to pale yellow solution free of visible particles and is supplied by TriSalus to the study sites in single-use vials. One vial is to be used per patient, and each vial should be discarded immediately after use.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
To assess the feasibility of neoadjuvant treatment with Nelitolimod delivered via PEDD in CRLM followed by surgical resection.
To assess the feasibility of neoadjuvant treatment with Nelitolimod delivered via PEDD in CRLM followed by surgical resection. Feasibility will be defined as at least 8 of 10 patients receiving surgery in a timely fashion (2-6 weeks). Enrollment will be stopped if 3 patients do not receive surgery in a timely fashion, irrespective of the number of patients enrolled. This is a safety and feasibility study for patients who as part of standard of care undergo liver resection.
Time frame
24 monthsSecondary outcomes
1
To assess the safety of Nelitolimod delivered via PEDD in CRLM.
To assess the safety of Nelitolimod delivered via PEDD in CRLM. To assess tumor regression score post-treatment with Nelitolimod and correlate with clinical outcomes, including: R0 rates, response (mRECIST), and DFS in resectable CRLM. AEs (graded by NCI CTCAE v5.0) attributed to the experimental drugs that prevent patients from getting the pre- planned surgery will be recorded, in addition to 30- day surgical complications rates. Tumor regression scores will be assessed post- treatment with Nelitolimod. The scores are based on a semiquantitative assessment of the ratio of viable tumor to fibrotic tissue. The scores range from 0 to 4, with 0 indicating no viable cancer cells and 4 indicating total regression. Tumor regression scores, response rate, and DFS are standard clinical parameters used to assess efficacy of a novel agent.
Time frame
36 monthsSponsors and contacts
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Source ClinicalTrials.gov