Pembrolizumab in Glioblastoma, IDH-Wildtype: NCT07385846 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: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Not yet recruiting
Recruitment status
8
Planned enrollment
2028-06-01
Primary-completion proxy
Executive view
NCT07385846 evaluates Pembrolizumab in Glioblastoma, IDH-Wildtype. The disclosed sponsor is Sponsor not reported, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Safety of using navigated focused ultrasound (NaviFUS) CTCAE v6.0, assessed over Assessed at each study visit from baseline through 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 NCT07385846 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Glioblastoma, IDH-Wildtype landscape. Drug & Asset MCP drug_fetch was queried for Pembrolizumab, 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 |
|---|---|---|---|---|---|---|
| NCT07385846 | Pembrolizumab | Phase 1 / Not yet recruiting | Sponsor not reported | United States | Safety of using navigated focused ultrasound (NaviFUS) CTCAE v6.0 Assessed at each study visit from baseline through 2 years. | 2028-06-01 |
| NCT07410676 | Pembrolizumab | Phase 1/2 / Recruiting | Essen BioTech LLC | China | Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) 30 DAYS | 2028-12-21 |
| NCT07392957 | Tovecimig | Phase 1/2 / Recruiting | Washington University School of Medicine | United States | Phase IB Arm 1: Toxicity as measured by number of participants with adverse events Start of treatment through 60 days after treatment (estimated to be 1… | 2029-06-30 |
| NCT07389278 | Temozolomide | Phase 1/2 / Not yet recruiting | The University of California, San Francisco | United States | Proportion of participants with Treatment-emergent Adverse Events (TrAE) (Phase 1) Up to 104 weeks | 2032-06-30 |
| NCT07391215 | Temozolomide | Phase 1/2 / Recruiting | The Institute of Cancer Research: Royal Cancer Hospital | United Kingdom | Phase 1b - Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) in patients with malignant brain tu… 12 months | 2029-01-19 |
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
NCT07385846 is a Phase 1, not yet recruiting study with 8 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Safety of using navigated focused ultrasound (NaviFUS) CTCAE v6.0” over “Assessed at each study visit from baseline through 2 years..” The retrieved endpoint description is: To evaluate the safety of using navigated focused ultrasound (NaviFUS) combined with pembrolizumab (PEM) after repeat surgery for patients with recurrent glioblastoma (rGBM) and mismatch repair (MMR) deficiency. Given that NaviFUS and PEM have defined intracranial dosing, no dose-escalation scheme will be employed. A CTCAE v6.0 grade 4 or higher toxicity probably or definitely attributable (see Section 13.2.3) to the administration of NaviFUS or PEM will be used as the definition for unacceptable toxicity.
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 8 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 Glioblastoma, IDH-Wildtype. These records do not establish direct evidence for NCT07385846 unless the registration number matches.
Phase 1 dose-escalation trial combining sulfasalazine and stereotactic radiosurgery in patients with recurrent glioblastoma
Phase 1; n=12; AE = Of 20 adverse events, two were grade 3 (transient lymphocytopenia), four grade 2, and fourteen grade 1 ; AE = Of 20 adverse events, two were grade 3 (transient lymphocytopenia), four grade 2, and fourteen grade 1 Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42229231/
Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide i…
Phase 2; n=624; Median Survival Time (Within Center Group)(Median): Cox Proportional Hazard = 0.95(70% CI, 0.81 - 1.10), P-Value = 0.25; Cox Proportional Hazard = 0.81(70% CI, 0.67 - 0.98), P-Value = 0.11; Median Survival Time (Within Center Group)(Median) = 22.8 months (95% Confidence Interval, 20.0 - 28.6) Source: https://clinicaltrials.gov/ct2/show/results/NCT02179086
Intracranial delivery of B7-H3-targeting CAR-T cells for recurrent glioblastoma: a phase 1 trial
Phase 1; n=15; TRAE(grade 3) = Three grade 3 TRAEs considered serious adverse events occurred (elevated intracranial pressure, epilepsy and depressed consciousness), two at DL3. Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42562965/
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
Pembrolizumab is indexed as Monoclonal antibody with PD-1 biology and a global stage of Approved. The asset profile lists Merck & Co., Inc. 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 Pembrolizumab 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: NCT07385846
Protocol source: https://clinicaltrials.gov/study/NCT07385846
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: 18 September 2026.
Pembrolizumab in Glioblastoma, IDH-Wildtype is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Safety of using navigated focused ultrasound (NaviFUS) CTCAE v6.0 and 2028-06-01 the leading decision points.
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