Actively Recruiting
INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases
Led by Northwell Health · Updated on 2026-03-19
10
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
INFINITIVE: ImmuNotherapy For PatIeNts wIth colorecTal LIVer MEtastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Adults aged 18 years or older
- Confirmed metastatic colorectal adenocarcinoma limited to the liver that can be surgically removed
- Liver-limited, resectable metastatic disease (ablations allowed to achieve complete tumor removal)
- Proficient mismatch repair/microsatellite stable metastatic colorectal cancer
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Patients planned for liver and primary tumor resection if synchronous disease
- Allowed total neoadjuvant therapy for rectal cancers
- At least 6 months since prior oxaliplatin-based adjuvant chemotherapy after primary tumor resection
- Completed standard preoperative chemotherapy regimens (FOLFOX, FOLFIRI, or FOLFIRINOX)
- Tumors must be fully resectable with adequate future liver remnant and preserved vascular and biliary function
- Adequate blood counts: ANC ≥ 1000/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 8 g/dL
- Blood chemistry: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal; total bilirubin ≤ 2 times upper limit (with exceptions for Gilbert Syndrome)
- Adequate kidney function with estimated glomerular filtration rate > 30 L/min
- Life expectancy greater than 6 months
- Women of childbearing potential and partners must use effective contraception during treatment and for specified periods after last dose
You will not qualify if you...
- Use of immunosuppressive systemic therapy within 7 days or investigational drugs within 28 days before trial
- Prior immune checkpoint blockade or immunomodulatory therapy for metastatic colorectal cancer
- History of organ transplantation including stem cell transplant
- Active autoimmune diseases that could worsen with immunotherapy
- Known severe allergic reactions to monoclonal antibodies
- Unresolved toxicities from previous cancer treatments above grade 2 (except neuropathy or immune-related toxicity)
- Pregnant, breastfeeding, or planning pregnancy during the study
- Unable to have TriNav PEDD catheter placed
- Recent arterial or venous thrombotic events within 6 months (with exceptions)
- Congestive heart failure of New York Heart Association class 2 or higher
- Unstable or recent serious heart conditions
- Poorly controlled high blood pressure
- Recent major surgery or significant injury within 28 days
- Non-healing wounds, ulcers, or bone fractures
- History or evidence of bleeding disorders or recent severe bleeding events
- Significant acute gastrointestinal disorders with major diarrhea
- Active or suspected autoimmune disease with exceptions for certain conditions
- Recent systemic corticosteroid or immunosuppressive treatment within 14 days
- History of pneumonitis requiring steroids or current lung disease
- Active infections requiring systemic therapy
- Known HIV/AIDS or active hepatitis B or C infection
- Recent live vaccines within 30 days
- Allergy or hypersensitivity to study drug components
- Any condition or abnormality that could interfere with study results or participation
- Inability to understand or give informed consent
- Any medical condition that may affect safety or compliance during the trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
RJ Zuckerberg
Lake Success, New York, United States, 11042
Actively Recruiting
Research Team
M
Micaela Wigfall Maxwell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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