OncoMatch/Clinical Trials/NCT05927142
Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy
Is NCT05927142 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Durvalumab and Rintatolimod for metastatic pancreatic cancer.
Treatment: Durvalumab · Rintatolimod — Pancreatic ductal adenocarcinoma (PDAC) is estimated to become the second leading cause of cancer-related death by 2030. Effective management of PDAC is challenged by a combination of late diagnosis, lack of effective screening methods and high risk of early metastasis. Although systemic chemotherapy improves survival, 5-year survival is only 6%. Chemotherapy efficacy is attenuated by innate and acquired drug resistance of tumor cells, a strong desmoplastic reaction that limits local accessibility of drugs and a "cold" tumor microenvironment (TME) with high infiltrating levels of immunosuppressive cells. In PDAC, increased T cell exhaustion defined by increased PD-1/PD-L1 activity in both peripheral blood and tumor microenvironment, is associated with poor prognosis. Hence the rationale for targeting the PD-1/PD-L1 axis with the aim to release the "brake" and exert an anti-tumor response. In PDAC successful results with Immune Checkpoint Inhibition (ICI) monotherapy are limited and combination therapy with other agents is encouraged; specifically agents that induce dendritic cell priming. We hypothesize that combination therapy of ICI therapy with a toll like receptor 3 (TLR-3) agonist is a potential effective strategy. TLR-3 agonists are hypothesized to increase dendritic cell maturation and cross-priming naïve cytotoxic CD8 T cells while eliminating regulatory T-cell attraction, thereby acting as an immune-boosting agent. We propose that rintatolimod/durvalumab-combination therapy is feasible and may induce synergistic anti-tumor immune responses in PDAC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Metastatic disease required
metastatic pancreatic cancer
Performance status
WHO 0–1
Prior therapy
Must have received: FOLFIRINOX
Stable disease according to RECIST criteria version 1.1 after at least 8 cycles of chemotherapy (FOLFIRINOX). Inclusion ≤ 6 weeks after stopping FOLFIRINOX.
Cannot have received: immunotherapy
Current treatment with immunotherapeutic drugs
Cannot have received: anticancer therapy
Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤28 days prior to the first dose of study drug
Cannot have received: radiation therapy
Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
Cannot have received: major surgery
Exception: Local surgery of isolated lesions for palliative intent is acceptable
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP
Lab requirements
Blood counts
WBC > 3.0 x 10^9/L, platelets > 75 x 10^9/L, ANC ≥1.0 × 10^9 /L and hemoglobin > 5.6 mmol/L
Kidney function
eGFR > 40 ml/min
Liver function
bilirubin ≤ 1.5 times normal; ALAT/ASAT ≤ 5 times normal
Adequate renal function (eGFR > 40 ml/min). Adequate liver tests (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, absolute neutrophil count (ANC) ≥1.0 × 10^9 /L and hemoglobin > 5.6 mmol/L). Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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