Bintrafusp alfa in Malignant Pleural Mesothelioma: NCT05005429 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 2
Clinical phase
Completed
Recruitment status
47
Planned enrollment
2024-02-01
Primary-completion proxy
Executive view
NCT05005429 evaluates Bintrafusp alfa in Malignant Pleural Mesothelioma. The disclosed sponsor is Sponsor not reported, the design is Interventional, and the geographic footprint is Spain. The first listed primary endpoint is To Evaluate the Efficacy of the Treatment, assessed over From administration of first dose of bintrafusp alfa until objective tumor progression or death, up to 2 years..
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 NCT05005429 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 Bintrafusp alfa, while Company & Deal Intelligence MCP organization_fetch was queried for Sponsor not reported.
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 |
|---|---|---|---|---|---|---|
| NCT05005429 | Bintrafusp alfa | Phase 2 / Completed | Sponsor not reported | Spain | To Evaluate the Efficacy of the Treatment From administration of first dose of bintrafusp alfa until objective… | 2024-02-01 |
| 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
NCT05005429 is a Phase 2, completed study with 47 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “To Evaluate the Efficacy of the Treatment” over “From administration of first dose of bintrafusp alfa until objective tumor progression or death, up to 2 years..” The retrieved endpoint description is: To determine the efficacy of M7824 in terms of the Progression Free Survival (PFS) assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1. Progression is defined using Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 as an increase of at least 20%in the sumof thediameters of viable (enhancing) target lesions, taking as reference the smallest sumof thediameters of the viable (enhancing) target lesions. The sum must also demonstrate an absoluteincrease of at least 5 mm..
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 47 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 NCT05005429 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
Bintrafusp alfa is indexed as Antibody fusion proteins with PDL1 x TGF-β biology and a global stage of Phase 3. The asset profile lists Merck Serono SA as an originator or developer.
No exact Company & Deal Intelligence profile was returned for Sponsor not reported. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
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 Bintrafusp alfa 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: NCT05005429
Protocol source: https://clinicaltrials.gov/study/NCT05005429
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.
Bintrafusp alfa in Malignant Pleural Mesothelioma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes To Evaluate the Efficacy of the Treatment and 2024-02-01 the leading decision points.
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