Poly ICLC in Malignant Pleural Mesothelioma: NCT04525859 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Completed
Recruitment status
19
Planned enrollment
2025-06-18
Primary-completion proxy
Executive view
NCT04525859 evaluates Poly ICLC in Malignant Pleural Mesothelioma. The disclosed sponsor is Oncovir, Inc., the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is The probability of rejecting the investigational treatment is at least 81%, if the DLT rate is greater than 33% and the probability of accepting the treatment is at least 71% if the DLT rate is less than a safe level of 17%., assessed over up to 27 days.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT04525859 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Malignant Pleural Mesothelioma landscape. Drug & Asset MCP drug_fetch was queried for Poly ICLC, while Company & Deal Intelligence MCP organization_fetch was queried for Oncovir, Inc..
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT04525859 | Poly ICLC | Phase 1 / Completed | Oncovir, Inc. | United States | The probability of rejecting the investigational treatment is at least 81%, if the DLT rate is greater than 33% and the… up to 27 days | 2025-06-18 |
| NCT05070247 | Tocilizumab | Phase 1/2 / Terminated | Takeda Pharmaceutical Co., Ltd. | United States | Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) Up to approximately 32.8 months | 2025-01-06 |
| NCT05071014 | Pembrolizumab | Phase 1 / Completed | Memorial Sloan Kettering Cancer Center | United States | number of patients with an adverse event (AE) defined as any grade 3 or higher non-hematologic toxicity within 12 weeks of cryoablation | 2023-12-18 |
| NCT05047536 | KZR-261 | Phase 1 / Terminated | Kezar Life Sciences, Inc. | United States | Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2) 20 months | 2025-01-17 |
| NCT05041062 | Ipilimumab | Phase 2 / Completed | The University of Chicago | United States | Major Pathologic (Disease) Response of Tumor to Nivolumab Combined With Ipilimumab Before Surgery 24 months | 2023-04-13 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT04525859 is a Phase 1, completed study with 19 planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.
The primary endpoint is “The probability of rejecting the investigational treatment is at least 81%, if the DLT rate is greater than 33% and the probability of accepting the treatment is at least 71% if the DLT rate is less than a safe level of 17%.” over “up to 27 days.” The retrieved endpoint description is: Safety will be assessed by the frequency and severity of toxicities by use of NCI-CTCAE 5.0 criteria..
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 19 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Malignant Pleural Mesothelioma. These records do not establish direct evidence for NCT04525859 unless the registration number matches.
First-Line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-Term PFS and OS
Phase 2; n=31; OS(24-month) = 25.0 % ; OS(24-month) = 50.7 % Source: https://cattendee.abstractsonline.com/meeting/21487/Session/133
Checkmate 6DW: First-Line Nivolumab+Ipilimumab vs Platinum+Pemetrexed for Pleural Mesothelioma in Chinese Patients
Phase 2; n=102; mPFS = 6.97 month ; mPFS = 6.93 month Source: https://cattendee.abstractsonline.com/meeting/21487/Session/195
Tumour Extrinsic Regulation of Neutrophils Sensitize Mesotheliomas to AXL and PD1 Inhibition inMIST3, a Phase II Clinical Trial
Phase 2; n=21; DCR(12-week) = 46.2 % ( 29.2 - 63.8) Source: https://cattendee.abstractsonline.com/meeting/21487/Session/133
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Poly ICLC is indexed as Polymer with TLR3 biology and a global stage of Approved. The asset profile lists originator not reported as an originator or developer.
Oncovir, Inc. is indexed in United States with the website https://www.oncovir.com. Oncovir is a pharmaceutical company dedicated to the development of nucleic-acid-based clinical therapies. The record lists 3 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Poly ICLC is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT04525859
Protocol source: https://clinicaltrials.gov/study/NCT04525859
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.
Poly ICLC in Malignant Pleural Mesothelioma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes The probability of rejecting the investigational treatment is at least 81%, if the DLT rate is greater than 33% and the probability of accepting the treatment is at least 71% if the DLT rate is less than a safe level of 17%. and 2025-06-18 the leading decision points.
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