Fianlimab/Cemiplimab in Urothelial Carcinoma of the Urinary Bladder: NCT07414992 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 2
Clinical phase
Withdrawn
Recruitment status
0
Planned enrollment
2028-03-01
Primary-completion proxy
Executive view
NCT07414992 evaluates Fianlimab/Cemiplimab in Urothelial Carcinoma of the Urinary Bladder. The disclosed sponsor is Memorial Sloan Kettering Cancer Center, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Rate of pathologic downstaging, assessed over 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 NCT07414992 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Urothelial Carcinoma of the Urinary Bladder landscape. Drug & Asset MCP drug_fetch was queried for Fianlimab/Cemiplimab, while Company & Deal Intelligence MCP organization_fetch was queried for Memorial Sloan Kettering Cancer Center.
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 |
|---|---|---|---|---|---|---|
| NCT07414992 | Fianlimab/Cemiplimab | Phase 2 / Withdrawn | Memorial Sloan Kettering Cancer Center | United States | Rate of pathologic downstaging 2 years | 2028-03-01 |
| NCT07505615 | Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin) | Phase 1/2 / Completed | Fudan University | China | Relapse-Free Survival 12 months from last participant enrolled | 2023-04-28 |
| NCT07495072 | Chondroitin Sulfate Sodium | Not Applicable / Recruiting | Sponsor not reported | South Korea | Change from baseline in the combined Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index… Baseline (Week 0), after 3rd BCG instillation (Week 3), after 6th BCG… | 2026-12-01 |
| NCT07492628 | Fludarabine Phosphate | Phase 1 / Recruiting | Beijing Biotech | China | Incidence of dose-limiting toxicities (DLTs) 28 Days | 2027-06-14 |
| NCT07483970 | JL-19001 | Phase 1 / Recruiting | Jieke (Tianjin) Biomedical Co Ltd | China | Number of participants with reported Dose-limiting toxicity (DLT) Within 21 days after the first administration | 2027-03-30 |
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
NCT07414992 is a Phase 2, withdrawn study with 0 planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Rate of pathologic downstaging” over “2 years.” The retrieved endpoint description is: Pathologic downstaging will be defined as lack of muscle invasive carcinoma (\<ypT2) and the absence of lymph node metastasis (ypN0) in the final cystectomy specimen after radical cystectomy..
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 0 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 Urothelial Carcinoma of the Urinary Bladder. These records do not establish direct evidence for NCT07414992 unless the registration number matches.
Pilot Study of BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
Not Applicable; n=4; No numerical result field reported Source: https://clinicaltrials.gov/ct2/show/results/NCT02657486
Artificial intelligence for predicting BCG response in non‐muscle‐invasive bladder cancer: a systematic review
Phase 3; n=24900; BCG-unresponsive disease: P-Value = 0.029; BCG-unresponsive disease: P-Value = 0.029 Source: https://pubmed.ncbi.nlm.nih.gov/42605566/
UGN-102 for Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer: 24-Month Duration of Response Results From the Phase 3 ENVISION Trial
Phase 3; n=240; Adverse Event: dysuria = Treatment-emergent adverse events that occurred in ≥10% of enrolled patients (N = 240) was dysuria Source: https://pubmed.ncbi.nlm.nih.gov/41880645/
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
Fianlimab/Cemiplimab is indexed as Monoclonal antibody with LAG3 x PD-1 biology and a global stage of Phase 3. The asset profile lists Regeneron Pharmaceuticals, Inc. as an originator or developer.
Memorial Sloan Kettering Cancer Center is indexed in United States with the website http://www.mskcc.org. Memorial Sloan - Kettering Cancer Center develops health-related apps and educational programs for mobile platforms. The record lists 149 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 Fianlimab/Cemiplimab 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: NCT07414992
Protocol source: https://clinicaltrials.gov/study/NCT07414992
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.
Fianlimab/Cemiplimab in Urothelial Carcinoma of the Urinary Bladder is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Rate of pathologic downstaging and 2028-03-01 the leading decision points.
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