AIM's DURIPANC trial nears enrollment finish, primary readout due December
The Ampligen-durvalumab pancreatic cancer study plans to close enrollment in July 2026, setting up a December clinical benefit rate readout with no direct precedent in the field.
Executive Summary
- A small investigator-led trial combining a checkpoint inhibitor with a TLR3 agonist in pancreatic cancer patients who stabilized on chemotherapy is moving toward full enrollment, positioning its primary disease-control readout for later this year.
- The combination targets a population where surviving first-line chemotherapy alone offers no established immunotherapy follow-on, making the readout a test of whether checkpoint blockade paired with innate-immune stimulation can extend disease control in this specific window.
- Earlier-phase results from the same program reported prolonged progression-free and overall survival without significant toxicity, a signal that supported moving into the current expansion but has not yet been confirmed in the larger cohort.
- With no other program pairing this checkpoint target and this innate-immune mechanism in pancreatic cancer, the trial sits without a direct precedent to benchmark against, raising the bar for what a clean readout would need to show.
The milestone
DURIPANC, registered as NCT05927142, is a Phase 1/2 study run by Erasmus Medical Center in the Netherlands in collaboration with AIM ImmunoTech and AstraZeneca. AIM ImmunoTech said in a February 23, 2026 disclosure that the trial had enrolled 18 subjects at that point, with a plan to complete enrollment in July 2026, complete dosing in August 2026, and evaluate the primary endpoint of clinical benefit rate in December 2026. The trial targets 43 patients with metastatic pancreatic ductal adenocarcinoma who achieved stable disease after at least eight cycles of FOLFIRINOX. NCT05927142+1Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy EfficacyNCT05927142AIM ImmunoTech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and ...Feb 23, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
The primary endpoint is clinical benefit rate, defined as stable disease, partial response, or complete response at 24 weeks after starting combination therapy with durvalumab and rintatolimod. Secondary endpoints due in June 2027 include progression-free survival, overall survival, a greater than 50% increase in circulating Ki67+ CD8+ T cells at 12 weeks, changes in tumor-infiltrating immune profile, and quality-of-life scores through EORTC QLQ-C30. Lead investigator Marjolein Y.V. Homs of Erasmus MC Cancer Institute said the progression-free survival and overall survival signal seen in the trial's Phase 1 portion, which supported advancing to Phase 2, continues to be observed as enrollment proceeds, and that no significant toxicity has emerged so far. NCT05927142+1Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy EfficacyNCT05927142AIM ImmunoTech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and ...Feb 23, 2026
Registry history
The trial's primary completion date moved once, from October 1, 2025 to April 1, 2026, recorded alongside its transition from Not Yet Recruiting to Recruiting status in January 2024. That is the only primary completion date change on record, and the trial's enrollment target has not changed from 43 patients since the study began, a pattern the trial's own operational data reads as a routine, low-churn protocol history. The trial carries Orphan Drug designation for rintatolimod in pancreatic cancer from both the FDA and the European Medicines Agency, granted in August 2025, signaling regulatory recognition of unmet need in this population rather than any judgment on the trial's eventual result. NCT05927142+1Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy EfficacyNCT05927142AIM ImmunoTech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and ...Feb 23, 2026
The competitive frame
PD-L1-targeted therapies are broadly represented across oncology, with checkpoint inhibitors advancing through Phase 3 programs in breast, gastric, and hepatocellular cancers. None of the PD-L1-directed programs identified in pancreatic cancer specifically pair a checkpoint inhibitor with a TLR3 agonist; the closest pancreatic-specific PD-L1 comparator uses a vaccine approach rather than an innate-immune agonist. That leaves DURIPANC without a direct mechanism-matched precedent in this indication, positioning the trial's December clinical benefit rate readout as the first test of whether this specific combination reproduces the disease-control signal reported in its earlier-phase portion.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.