This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT) (NCT06571708), a randomized phase 2 study. The primary outcome is Clinical Complete Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06571708 |
| Phase | Phase 2 |
| Condition | Bladder Cancer, Muscle-Invasive Bladder Carcinoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Columbia University |
| Results posted | Yes |
2. Clinical Question
Population
Adults with localized muscle-invasive bladder cancer. The registry record describes a trial intended to study organ preservation in this population. It reports enrollment of 1 participant and says outcome data were not analyzed or disclosed to protect participant confidentiality.
Intervention
Gemcitabine, cisplatin, cemiplimab, and fianlimab. The treatment description includes 4 cycles of neoadjuvant therapy, followed by repeat maximal transurethral resection of bladder tumor and imaging. Participants meeting the complete-response criteria were to continue maintenance treatment.
Comparator
Gemcitabine, cisplatin, and cemiplimab without fianlimab. The study is randomized, open-label, and parallel-group. The registry record does not report an outcome comparison between the treatment groups.
Primary question
What rate of clinical complete response follows 4 cycles of neoadjuvant chemoimmunotherapy, assessed at 16 weeks? The endpoint requires no high-grade malignancy on repeat TURBT, no malignant cells on urine cytology, and no definitive invasive local or metastatic disease on cross-sectional imaging.
The central statistical question is whether adding fianlimab is associated with a different clinical complete-response rate than the regimen without fianlimab. Random assignment is intended to support a comparison between treatment strategies, but the record does not provide the group-specific response data needed to estimate that contrast. With outcome data withheld and no summary-level results available, the record cannot establish the observed response rate in either arm or the difference between them.
The registry description also outlines a treatment pathway after response assessment. Participants with a complete response were to continue maintenance cemiplimab or cemiplimab with fianlimab; participants without a complete clinical response were to undergo cystectomy. These planned pathways explain the clinical context of the endpoint, but they do not provide evidence about outcomes in this study.
3. Trial Design
NeoSTOP-IT is registered as a phase 2 randomized, open-label, parallel-group study sponsored by Columbia University. It concerns adults with localized muscle-invasive bladder cancer and evaluates gemcitabine, cisplatin, and cemiplimab with or without fianlimab. Open-label means the registry does not describe masking of treatment assignment. The allocation is randomized, but the record does not report further details about how the randomization sequence was generated or implemented.
The treatment arms share gemcitabine, cisplatin, and cemiplimab; fianlimab is included in one arm. The brief summary describes transurethral resection of bladder tumor before treatment, followed by 4 treatment cycles of 21 days. After those cycles, participants were to undergo repeat maximal TURBT with imaging. A complete response was to lead to maintenance treatment with cemiplimab or cemiplimab and fianlimab, while participants without a complete clinical response were to undergo cystectomy. The record describes maintenance as 13 more cycles. These are protocol descriptions, not reported observations about what the participant received or experienced.
The registry lists a start date of 2025-08-14, primary completion date of 2026-01-05, and status of terminated. Enrollment is reported as 1. The record does not state why the study was terminated, whether termination occurred before or after the planned primary assessment, or whether the planned treatment course was completed. Those details are not reported in the registry record and should not be inferred from the status alone.
Clinical complete response is the primary outcome, with a timeframe of 16 weeks. Secondary outcomes listed are number of adverse events, bladder-intact survival, recurrence-free survival, and overall survival. The record lists 5 outcome measures but reports no statistical analyses. It does not describe the intended analysis population, the analysis method for the primary outcome, or how secondary outcomes were to be analyzed.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | All Participants |
|---|---|
| STARTED | 1 |
| COMPLETED | 1 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Data was not analyzed or disclosed in an effort to protect participant confidentiality (n=1). Additionally, since there is only one participant, it is not possible to report summary level data.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Data was not analyzed or disclosed in an effort to protect participant confidentiality (n=1).
| Characteristic | Unit | All Participants |
|---|---|---|
| Participants analysed | 0 | |
| Sex: Female, Male: Female | Participants | — |
| Sex: Female, Male: Male | Participants | — |
| Region of Enrollment: United States | participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Clinical Complete Response, measured over 16 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the rate of clinical complete response after 4 cycles of neoadjuvant chemoimmunotherapy, assessed at 16 weeks. A participant meets the registry definition only if all stated conditions are satisfied: repeat TURBT shows no high-grade malignancy; urine cytology shows no malignant cells; and cross-sectional imaging shows no definitive evidence of invasive local or metastatic disease. The record specifies CT of the chest, abdomen, and pelvis with contrast, or MRI with contrast in the setting of renal dysfunction. Cystoscopy and imaging should occur within 4 weeks of the end of neoadjuvant therapy.
In general, a composite endpoint combines multiple findings into one outcome. Here, the criteria bring together tissue assessment, urine cytology, and imaging rather than relying on one type of evidence. Requiring all components makes the endpoint a defined clinical state across these assessment methods. The response rate would ordinarily describe the share of participants meeting the full definition in a specified group. The registry record does not disclose response counts or a summary rate, so that quantity cannot be estimated from the posted results.
In general, an early response endpoint can be useful for assessing whether a treatment strategy produces the specified response at a clinically relevant assessment point. It is not interchangeable with longer-term outcomes such as bladder-intact survival, recurrence-free survival, or overall survival. Those outcomes are separately listed as secondary measures in this record, but their results are not reported. A clinical complete response at the stated assessment therefore should not be treated as proof of later disease control or organ preservation.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record does not provide an estimate of clinical complete response. It explicitly states that data were not analyzed or disclosed to protect participant confidentiality and that summary-level data cannot be reported because there is only one participant. Consequently, neither the response rate nor an uncertainty interval can be interpreted from this record. No comparison of response between the regimen with fianlimab and the regimen without it is reported.
Although the study is randomized and has two described treatment strategies, the existence of randomization does not by itself produce an interpretable treatment effect. A comparison requires outcome information linked to the treatment groups. The record reports no arm-level response counts, no effect estimate, and no statistical analysis. The registry also indicates that no analyses are reported. Therefore, there is no basis in the posted results to determine the direction or magnitude of a difference between the groups.
The enrollment of 1 is important context for the absence of summary results. The registry's confidentiality explanation means that the result is intentionally not presented at participant or group level. It would be inappropriate to infer a response or nonresponse from the fact that enrollment is small, from the study's termination status, or from the treatment schedule. The record does not say whether the participant completed therapy or underwent the planned assessments.
The adverse-event record lists an all-participants group with zero participants at risk and zero recorded events in its displayed categories. These entries do not establish that there were no adverse events. With no participants at risk in that summary, they cannot support an interpretable event rate or a safety comparison. The record does not disclose participant-level safety data, and no serious adverse-event terms are listed.
In general, a confidence interval expresses the precision of an estimated quantity under a stated analysis. No confidence interval is reported for this endpoint, and the underlying response data are unavailable, so precision cannot be assessed. There is likewise no p-value or other inferential result for a treatment contrast. The registry record does not report a statistical analysis plan, an interim analysis, or an explanation for termination.
The posted information is therefore descriptive of the trial's registration, planned treatments, endpoint definition, status, and non-disclosure of outcome data. It is not an efficacy or comparative-effectiveness result. Any conclusion about the response to either regimen, a benefit from adding fianlimab, or the relative safety of the treatment strategies would go beyond what the record reports.
9. Statistical Methods Explained
Clinical trial results are most informative when the endpoint, analysis population, group-level observations, and statistical method are all available. For NeoSTOP-IT, the registry defines a primary clinical complete-response endpoint and describes randomized treatment groups, but it does not provide response observations or a statistical analysis. The distinction matters: a clearly defined endpoint describes what would be measured, whereas an analysis estimates what was observed and how uncertain that estimate is.
What does a response rate represent?
In general, a response rate is the proportion of participants in a defined group who meet a prespecified response definition. The denominator depends on the analysis population and on how missing assessments are handled. Those choices can affect the interpretation, especially when some participants do not complete treatment or do not have the endpoint assessment. The registry record does not report an analysis population, response numerator, denominator, or missing-outcome rule for this trial. No response rate can therefore be reconstructed.
The endpoint in this study is composite in the clinical sense: it requires a set of findings across repeat TURBT, urine cytology, and imaging. In general, a participant would need to satisfy each listed criterion to count as a complete response under such a definition. This makes clarity about assessment timing and handling of incomplete assessments important. The registry specifies the 16-week timeframe and says cystoscopy and imaging should occur within 4 weeks of the end of neoadjuvant therapy, but it does not report how deviations from that schedule or missing components were to be classified.
Why does randomization matter?
In general, randomization assigns participants to treatment groups using a chance-based process. It is intended to reduce systematic differences between groups at the start of a study, supporting a fair comparison of outcomes. It does not guarantee that groups will be comparable in every respect, and it does not replace the need to report outcomes. Here, the registry describes random allocation and parallel treatment groups, but no group-specific outcome values are disclosed. The treatment contrast cannot be estimated from the design description alone.
The study is open-label, meaning the record reports no masking of treatment assignment. In general, knowledge of assigned treatment can influence some aspects of care, assessment, or reporting, depending on the outcome and study procedures. The record does not describe safeguards against such influences or the role of independent assessment. These details are not reported in the registry record, so their implementation cannot be characterized.
How should uncertainty be understood?
In general, a confidence interval describes a range of values compatible with the observed data under the analysis assumptions. It helps readers assess both the estimated effect and its precision; it does not guarantee that the true effect lies within the interval. No estimate or confidence interval is reported for the primary endpoint. Because outcome data are not disclosed, there is no statistical basis for describing precision around a response rate or treatment difference.
A p-value, when used, addresses how compatible data are with a specified null hypothesis under a statistical model. It does not measure the probability that a treatment works, and it does not replace an effect estimate or confidence interval. No p-value or inferential comparison is reported in this registry record. The record also does not report a prespecified statistical analysis plan, so the intended model, testing procedure, and any adjustment for multiple outcomes cannot be assessed.
What do the planning assumptions mean?
In general, sample-size planning uses assumptions about the effect to be detected, the significance level, allocation, and the statistical method to illustrate how much information a future study might need. The registry describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also says the illustrated effect is a stated fraction of the observed effect. Such planning quantities are not observed power and are not trial outcomes.
For this record, no observed primary effect is available because the response data were not analyzed or disclosed. No numerical planning illustration can therefore be interpreted as an estimate of this trial's result. In general, over-dispersion occurs when outcome variability exceeds what a chosen statistical model assumes; if present, it can make standard errors too small and confidence intervals too narrow unless the analysis accounts for it. The registry does not report a model or distributional assessment for this endpoint, and the record offers no data with which to evaluate over-dispersion.
The record's enrollment is 1, but this should not be confused with a completed analysis or a basis for estimating comparative effects. Nor does a planning calculation demonstrate that a study had adequate or inadequate power. No power calculation for the trial's own design, sample-size justification, or observed-power analysis is reported in the registry record.
What can be learned from the safety fields?
In general, adverse-event summaries need a clear population at risk, a defined observation period, and consistent event ascertainment. Counts without a usable denominator cannot be interpreted as rates. The posted adverse-event group reports zero at risk and zero recorded events in the listed categories. Those entries do not support a conclusion that the treatment caused no adverse events, and they cannot be compared across treatment groups. The record does not disclose event-level data or a safety analysis method.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study evaluates more than one endpoint, comparison, time point, or statistical hypothesis. In general, testing multiple hypotheses can increase the chance of at least one apparently notable result under a null setting. Trial protocols may address this through prespecified testing sequences or other adjustments, but the appropriate approach depends on the study objectives and analysis plan.
This registry lists clinical complete response as the primary outcome and lists number of adverse events, bladder-intact survival, recurrence-free survival, and overall survival as secondary outcomes. It does not report a multiplicity strategy or a statistical analysis plan. There are no outcome analyses or p-values in the posted results, so no correction or testing hierarchy can be evaluated. These details are not reported in the registry record.
Missing-data handling is also not described. In general, missing endpoint assessments can affect a response-rate estimate if participants without an assessment are treated differently from those with an observed response classification. The record does not state how incomplete TURBT, cytology, or imaging assessments would be handled, whether participants who did not complete treatment would remain in the primary analysis, or how missing follow-up would affect secondary outcomes. No imputation method or sensitivity analysis is reported.
The record does not identify an intention-to-treat, per-protocol, or safety analysis population. It also does not report how participants were to be included in each outcome analysis. With one participant enrolled and no disclosed outcome data, these omissions prevent assessment of analysis-population choices as well as any potential influence of missing observations.
11. What the Result Does, and Does Not, Mean
The registry record establishes that NeoSTOP-IT was designed to compare gemcitabine, cisplatin, and cemiplimab with the same regimen plus fianlimab in localized muscle-invasive bladder cancer. It also defines a 16-week clinical complete-response endpoint and records a terminated status. These are details about the study design and registry entry, not evidence that either treatment strategy produced a particular response.
The record does not report a clinical complete-response result, a response rate, or an arm-to-arm treatment effect. Its explanation is that data were not analyzed or disclosed to protect participant confidentiality, and that summary-level reporting was not possible because there was only one participant. Thus, the record cannot show whether the participant met the endpoint definition, whether the treatment arms differed, or how precise any estimate would be.
In general, a response on an early assessment does not by itself establish longer-term disease control, recurrence outcomes, survival, or preservation of the bladder. The registry lists bladder-intact survival, recurrence-free survival, and overall survival as secondary outcomes, but it reports no results for them. The planned pathway of maintenance treatment after complete response and cystectomy after lack of complete clinical response does not indicate which pathway occurred.
The reported adverse-event entries also do not establish absence of harm. A group with zero participants at risk cannot yield an interpretable safety rate, and the record does not provide an event comparison between the treatment strategies. No conclusion about relative safety can be drawn from those entries.
In practical statistical terms, the posted results support no claim that adding fianlimab improves, worsens, or leaves unchanged the response rate. They also do not establish that the regimen without fianlimab has a particular response rate. The absence of a disclosed estimate is not evidence of no effect; it means the treatment effect is unknown from this registry record.
12. Why This Trial Matters Statistically
This study poses a clear comparative question: whether adding fianlimab to gemcitabine, cisplatin, and cemiplimab changes the chance of meeting a defined clinical complete-response endpoint. The endpoint combines pathology, cytology, and imaging, giving the response assessment a broader basis than any single test. Its interpretation depends on meeting the full set of criteria at the stated assessment timeframe.
The study also illustrates why design information and results information answer different questions. Randomization and parallel treatment groups describe how a comparison was intended to be made. They do not reveal the outcome of that comparison. Without disclosed response data, group-level estimates, or uncertainty measures, the comparative question remains unanswered by the posted results.
The record's enrollment of 1 and its confidentiality explanation place a strong limit on statistical reporting. In a small record, suppressing individual-level results can protect privacy, while also leaving readers without a summary estimate. This creates an important distinction between the reason results are unavailable and what can be concluded scientifically: confidentiality explains non-disclosure, but it does not establish the direction or size of a treatment effect.
Finally, the terminated status and lack of reported analyses make it especially important not to treat the planned treatment course as an observed clinical outcome. The record is useful for identifying the trial's intended population, treatments, endpoint definition, and status. It does not provide the evidence needed to quantify response, compare regimens, or evaluate longer-term outcomes.
13. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation is that no primary endpoint data or summary-level result is disclosed. The registry states that data were not analyzed or disclosed to protect participant confidentiality and notes that there was only one participant. As a result, there is no response rate, arm-specific estimate, treatment contrast, or measure of uncertainty to interpret.
The record does not report whether the participant completed the planned treatment, underwent the scheduled response assessment, or met any of the clinical complete-response criteria. It also does not report the reason for termination or whether termination affected the planned endpoint assessment. The status alone cannot resolve those questions.
No statistical analysis plan, analysis population, missing-data method, multiplicity procedure, or endpoint analysis is reported. These omissions prevent evaluation of how the primary response rate would have been calculated, how incomplete assessments would have been treated, and how secondary outcomes would have been analyzed. No results are reported for the listed secondary outcomes.
Safety interpretation is similarly limited. The adverse-event summary lists zero participants at risk and zero events in the displayed categories, rather than an interpretable treatment-group denominator and event summary. No safety comparison or event-level detail is reported.
The treatment description is also incomplete for one intervention: the arm description for fianlimab is truncated. The registry's brief summary gives the planned response-based follow-up pathways, but does not establish what occurred. These limitations mean the record can describe study intent and reporting status, but cannot support an estimate of efficacy, comparative effect, or safety.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT) — NCT06571708.
- Registry record last updated 2026-11-03; status last verified 2026-10.
- Results first posted 2026-11-03.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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17. Record Summary
NeoSTOP-IT (NCT06571708) is a randomized, open-label, phase 2 parallel-group study sponsored by Columbia University. It concerns gemcitabine, cisplatin, and cemiplimab with or without fianlimab for adults with localized muscle-invasive bladder cancer. The registry reports enrollment of 1, a start date of 2025-08-14, a primary completion date of 2026-01-05, and terminated status.
The primary outcome is clinical complete response at 16 weeks after 4 cycles of neoadjuvant chemoimmunotherapy, defined using repeat TURBT, urine cytology, and cross-sectional imaging. Secondary outcomes include adverse events, bladder-intact survival, recurrence-free survival, and overall survival.
The record reports no statistical analyses and no summary-level outcome data. It states that data were not analyzed or disclosed to protect participant confidentiality. Therefore, no primary response estimate, treatment comparison, or interpretable safety result is available from the posted results.