NCT07465276 Ficerafusp alfa Squamous Cell Carcinoma of Head and Neck Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07465276 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07465276 is a hot trial to watch
Squamous Cell Carcinoma of Head and Neck is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07465276 is notable because it evaluates Ficerafusp alfa in a Phase 2 design sponsored by Dana-Farber Cancer Institute, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07465276 |
| Official title | Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Ficerafusp alfa |
| Sponsor | Dana-Farber Cancer Institute, Inc. |
| Geography | United States |
| Enrollment | 32 |
| Primary endpoint | Pathologic Treatment Response-2 (pTR-2) Rate |
| Endpoint time frame | Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment. |
| Primary completion / readout proxy | 2028-04-30 |
Protocol design and endpoint interpretation
This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC). The names of the study drugs used in this research study are: * ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein) * pembrolizumab (a type of monoclonal antibody)
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 32 participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Pathologic Treatment Response-2 (pTR-2) Rate (Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.) — pTR-2 rate is defined as ≥50% pathological response of the primary tumor using the surgical specimen following neoadjuvant therapy as established by 2 independent pathologists.
Readout outlook and evidence gap
The current protocol points to 2028-04-30 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Ficerafusp alfa is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Dana-Farber Cancer Institute, Inc. is resolved to a normalized organization record in SUFFOLK COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07465276 provides a focused lens on Squamous Cell Carcinoma of Head and Neck development. Its value will be determined by whether Ficerafusp alfa can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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