NCT07475806 Enfortumab Vedotin-ejfv Muscle Invasive Bladder Carcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07475806 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 NCT07475806 is a hot trial to watch
Muscle Invasive Bladder Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07475806 is notable because it evaluates Enfortumab Vedotin-ejfv in a Phase 2 design sponsored by Astellas Pharma Global Development, 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 | NCT07475806 |
| Official title | A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Enfortumab Vedotin-ejfv |
| Sponsor | Astellas Pharma Global Development, Inc. |
| Geography | South Korea, United States, Japan, United Kingdom, Germany, Spain |
| Enrollment | 240 |
| Primary endpoint | Overall clinical complete response (cCR) rate after treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator |
| Endpoint time frame | Up to 27 weeks |
| Primary completion / readout proxy | 2027-11-30 |
Protocol design and endpoint interpretation
People with a type of bladder cancer called muscle-invasive bladder cancer have cancer that has spread into the muscle wall of the bladder. The standard treatment is to have chemotherapy, followed by surgery to completely remove the bladder. This has a significant impact on people with long-term life-altering changes. There are also limited options for people who cannot have chemotherapy or who do not want their bladder removed. Studies show that enfortumab vedotin, when given with pembrolizumab, can help people with advanced bladder cancer. This treatment has also worked well for people with muscle-invasive bladder cancer who can't receive chemotherapy when it was given before and after bladder-removal surgery. However, some people can't have or won't have this surgery. There is still a need for new treatments that let people keep their bladder. This is especially important for people who respond well to the enfortumab vedotin, when gi
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 240 participants across South Korea, United States, Japan, United Kingdom, Germany, Spain 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.
- Overall clinical complete response (cCR) rate after treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator (Up to 27 weeks) — cCR rate is defined as the proportion of participants having cCR after treatment with enfortumab vedotin in combination with pembrolizumab. cCR is defined as no visible tumor detected on cystoscopy or no residual tumor on transurethral resection of bladder tumor (TURBT); no evidence of malignancy, except for the presence of Ta (low grade), and no radiographic evidence of residual or metastatic disease on imaging (mag
- Bladder-intact event-free survival (BI-EFS) rate in participants who achieve cRC after 9 cycles of treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator (2 years) — BI-EFS rate is defined as the proportion of participants who have not had an observed BI-EFS event 2 years after the first dose. BI-EFS is defined as the time from first dose to either histologically confirmed recurrent muscle-invasive bladder cancer (MIBC), disease progression, cystectomy, or death from any cause.
Readout outlook and evidence gap
The current protocol points to 2027-11-30 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: Enfortumab Vedotin-ejfv 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: Astellas Pharma Global Development, Inc. is resolved to a normalized organization record in 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
NCT07475806 provides a focused lens on Muscle Invasive Bladder Carcinoma development. Its value will be determined by whether Enfortumab Vedotin-ejfv can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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