Actively Recruiting
Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy
Led by Joachim Aerts, MD PhD · Updated on 2025-02-25
43
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Joachim Aerts, MD PhD
Lead Sponsor
A
AIM ImmunoTech Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pancreatic ductal adenocarcinoma (PDAC) is a serious cancer expected to become the second leading cause of cancer-related death by 2030. This research is exploring a new treatment combination for adults with metastatic PDAC who have stable disease after chemotherapy. The study focuses on combining durvalumab, an anti-PD-L1 immune checkpoint inhibitor, with rintatolimod, a toll-like receptor 3 (TLR-3) agonist, aiming to enhance the immune system's response against the tumor. Participants will receive intravenous infusions of rintatolimod twice weekly for 6 weeks, starting at 200mg and potentially increasing to 400mg. Durvalumab infusions of 1500mg begin in the second week and continue every 4 weeks for up to 48 weeks or until disease progression or unacceptable side effects occur. The study includes an initial safety phase followed by a phase II trial to assess the treatment's clinical benefit and immune effects. During the study, patients will have regular infusions, blood tests, and some will have tumor biopsies before treatment and after 12 weeks. Researchers will monitor safety, immune response, disease progression, survival rates, and quality of life. The total participation can last up to one year, with close follow-up and assessments to understand the treatment's impact and side effects.
CONDITIONS
Brief Title
Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic pancreatic cancer
- Stable disease after at least 8 cycles of FOLFIRINOX chemotherapy
- Enrollment within 6 weeks after stopping FOLFIRINOX
- Accessible metastatic lesion for tissue biopsy
- Systemic Immune-Inflammation Index (SIII) less than 900
- CA 19.9 tumor marker less than 1000 kU/L
- Age 18 years or older
- Body weight over 30 kg
- WHO performance status 0-1
- Adequate kidney function (eGFR > 40 ml/min)
- Adequate liver function (bilirubin ≤ 1.5 times normal; ALAT/ASAT ≤ 5 times normal)
- Adequate bone marrow function (WBC > 3.0 x 10^9/L, platelets > 75 x 10^9/L, ANC ≥ 1.0 x 10^9/L, hemoglobin > 5.6 mmol/L)
- Use of effective contraception
- Life expectancy of at least 12 weeks
- Willing and able to follow study protocol including visits and examinations
- Able to provide written informed consent
You will not qualify if you...
- Child-Pugh liver function grade B or C
- Current treatment with immunotherapy drugs
- Previous malignancy unless low risk and disease-free for over 3 years
- Malignant ascites or pleural effusion
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Allergy to study drugs or their components
- Active autoimmune diseases requiring systemic treatment in past 2 years (with some exceptions)
- Immunodeficiency or recent systemic immunosuppressive therapy
- Recent live attenuated vaccine (within 30 days before treatment)
- Prior participation in durvalumab clinical trials
- Participation in other investigational drug studies within 3 months
- Recent anticancer therapy without adequate washout
- Unresolved significant toxicity from prior therapy
- Concurrent cancer treatments (except certain hormonal therapies)
- Recent extensive radiotherapy or major surgery
- History of allogenic organ transplant
- Uncontrolled illnesses that may interfere with study
- Brain metastases or spinal cord compression
- QTcF interval ≥ 470 ms on ECG
- Active hepatitis B or C infection unless resolved
- Known HIV or active tuberculosis infection
- Serious systemic disorders affecting safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 48 weeks
Participants receive combination therapy with rintatolimod via IV infusion twice per week for 6 weeks and durvalumab via IV infusion every 4 weeks for up to 48 weeks or until disease progression or unacceptable toxicity.
Twice weekly visits for 6 weeks for rintatolimod infusions and monthly visits for durvalumab infusions up to 48 weeks
Duration - Up to 60 months
Participants are monitored for safety and treatment effects including immune response and survival after completing combination therapy or upon discontinuation.
Periodic visits for survival and immune profile assessments up to 60 months
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3000 CA
Actively Recruiting
Research Team
S
Songul Kucukcelebi, MD
J
Judith Verhagen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
1
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