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 Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer (NCT05263492), a na phase 2 study. The primary outcome is Determine the Objective Response Rate (ORR) at 24 Weeks in Black Patients With Recurrent Endometrial Cancer Treated With Lenvatinib 20 mg Orally Daily in Combination With Pembrolizumab 200 mg IV Every 3 Weeks.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05263492 |
| Phase | Phase 2 |
| Condition | Endometrial Cancer, Mismatch Repair-Proficient, Recurrent Endometrial Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Virginia Commonwealth University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned Black participants with mismatch repair-proficient recurrent endometrial cancer. The registry describes a planned primary assessment at 24 weeks and reports that the trial recruited 4 participants. It does not provide further participant characteristics or eligibility details in the record.
Intervention
The intervention was lenvatinib in combination with pembrolizumab. Lenvatinib was described as 20 mg orally once daily during each 21-day cycle. Pembrolizumab was described as 200 mg by intravenous infusion on day 1 of each 21-day cycle.
Comparator
There was no comparison group. The registry identifies a single-group study, with allocation and masking listed as not applicable and none, respectively. Outcomes therefore cannot be interpreted as a randomized comparison between treatments.
Primary question
The primary objective was to assess objective response rate at 24 weeks among Black participants with recurrent endometrial cancer treated with the combination. The registry describes response assessment according to RECIST v1.1, but says the study terminated before participants reached the prespecified assessment time points and response data were not collected. Consequently, the registry record does not report an observed response rate.
3. Trial Design
This was a multicenter, open-label phase 2 study of lenvatinib plus pembrolizumab in Black participants with mismatch repair-proficient recurrent endometrial cancer. The registry classifies the design as single group. It lists no masking and no allocation, so there is no randomized, masked comparison to another treatment or control group. The sponsor was Virginia Commonwealth University.
The intervention combined lenvatinib, 20 mg orally once daily during each 21-day cycle, with pembrolizumab, 200 mg by intravenous infusion on day 1 of each 21-day cycle. The primary outcome concerned objective response rate at 24 weeks. Its description refers to tumor response evaluated and recorded according to Response Evaluation Criteria in Solid Tumors, RECIST v1.1.
The registry lists a start date of 2022-04-01 and a primary completion date of 2024-09-13. The study status is terminated. It reports enrollment of 4 participants and states that data were not collected because termination occurred before participants' assessment at the prespecified time points. Thus the planned efficacy question was not answered by a reported primary outcome result.
Secondary outcomes include median progression-free survival, treatment-related adverse events, and discontinuation due to treatment-related adverse events. Median progression-free survival appears repeatedly in the outcome list. The registry record does not provide results for those secondary outcomes. It also does not report the reason for termination, the planned recruitment target, or a sample-size justification.
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 | Pembrolizumab & Lenvatinib |
|---|---|
| STARTED | 4 |
| COMPLETED | 0 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | Pembrolizumab & Lenvatinib |
|---|---|
| Adverse Event | 1 |
| Disease progression during active treatment | 3 |
Analysis population for the primary outcome, as defined in the registry: This trial only recruited 4 participants, data were not collected due to study termination prior to participants' assessment at the pre-specified time points
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: The trial was terminated. Only 4 participants were enrolled in this trial. Based on the low enrolment numbers, no data is reported here in order to protect and maintain participant privacy/confidentiality.
| Characteristic | Unit | Pembrolizumab & Lenvatinib |
|---|---|---|
| Participants analysed | 4 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 |
| Age, Categorical: >=65 years | Participants | 2 |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Determine the Objective Response Rate (ORR) at 24 Weeks in Black Patients With Recurrent Endometrial Cancer Treated With Lenvatinib 20 mg Orally Daily in Combination With Pembrolizumab 200 mg IV Every 3 Weeks, measured over 24 Weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
Objective response rate is intended to describe the proportion of assessed participants whose tumors meet criteria for an objective response over a defined assessment period. In this study, the stated time point was 24 weeks, and the registry refers to RECIST v1.1 for evaluating and recording tumor response. This type of endpoint can characterize tumor response without requiring a comparison to another treatment group, although interpretation is limited when there is no control arm.
The registry's primary outcome description emphasizes the number of participants evaluable for measurement of tumor response. That is not the same as a reported response rate: an evaluability count indicates whether response could be assessed, while a response rate requires outcome information on responses under the defined criteria. The record says response data were not collected because the study terminated before participants' prespecified assessment time points. It therefore gives neither an observed response result nor enough outcome information to estimate the primary endpoint.
In general, a prespecified assessment time point helps make the endpoint interpretable by establishing when response is to be assessed. It does not, by itself, ensure that the endpoint is observed. In this record, the stated time point is known, but the primary response outcome is unavailable.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the primary efficacy outcome is not reported. The registry states that the study recruited 4 participants, but that data were not collected because termination occurred before participants' assessment at the prespecified time points. This means the record does not establish an objective response rate at 24 weeks. It is not appropriate to treat the lack of a reported response result as evidence that no participant responded, or that all participants responded.
The design was single group and open label, with no comparator. Even if an outcome had been reported, a single-group result would describe outcomes in the enrolled participants and would not by itself estimate a treatment effect relative to a control group. Here, the absence of primary response data further limits what can be inferred: the specified efficacy question remains unanswered in the posted record.
The registry does report safety-related counts. In the combination group, the serious adverse event fields list 4 participants at risk and 0 affected; the other adverse event fields list 4 at risk and 4 affected. The record also lists 2 deaths. These are separate registry fields and should not be treated as evidence about cause, timing, or relationship to study treatment. The registry record does not establish that deaths were caused by treatment, nor does it provide details that would support that conclusion.
The registry lists median progression-free survival and treatment-related adverse events among secondary outcomes, but it does not report their results. A listed outcome is not a result. Similarly, the absence of reported statistical analyses does not show that an analysis found no effect; it means the registry record contains no analysis results to interpret. The record lists 0 analyses.
Overall, the posted data support a description of the study's design, intended primary endpoint, enrollment, termination status, and selected adverse-event counts. They do not support a conclusion about the combination's efficacy in this population. The limited enrollment and missing prespecified efficacy assessments also mean that the record cannot provide a precise estimate of response or its uncertainty.
9. Statistical Methods Explained
What does a single-group design tell readers?
The study is classified as single group, with no allocation and no masking. A single-group design can describe outcomes among participants who receive the study intervention, but it has no concurrent control group for separating treatment-associated outcomes from other influences. In general, a randomized comparison helps address differences between groups through the process of allocation. That comparison is absent from this design. It would therefore be inappropriate to interpret any within-group outcome as a comparative treatment effect.
The open-label designation means the study was not masked. The registry does not report further details about how outcome assessment was organized. In general, knowledge of assigned treatment can influence some aspects of reporting or assessment, which is one reason that masking may be used in trial designs. This general point does not establish that bias occurred in this study.
What does an objective response endpoint measure?
In general, objective response rate is based on classifying tumor response under specified criteria and then describing the frequency of participants meeting response criteria among those assessed. The record names RECIST v1.1 and specifies a 24-week assessment. Reliable interpretation requires the response classifications and a clear account of who was assessed and how missing assessments were handled. The registry says these data were not collected before study termination, so no response estimate or uncertainty interval is available in the record.
A confidence interval, in general, expresses the statistical uncertainty around an estimated quantity under a specified analysis. It is useful because a point estimate alone does not show how precisely the underlying quantity has been estimated. Here, no primary response estimate is reported, so there is no corresponding confidence interval to interpret. No confidence interval method is reported in the registry record.
What analysis methods are reported?
The registry record lists 0 analyses. It does not report a statistical analysis plan, a model for the primary endpoint, a method for estimating progression-free survival, or an approach to adjusting for other variables. It also does not report a planned or completed interim analysis. These omissions mean that the analysis procedures cannot be reconstructed from the record. They should not be filled in by assuming a conventional method.
In general, analysis choices should match the endpoint and study design. A binary response outcome may be described using a response count and an appropriate denominator; a time-to-event outcome such as progression-free survival requires information about event times and censoring. Those are general distinctions, not methods reported for this study. Because the primary outcome data were not collected and secondary outcome results are not posted, no such endpoint-specific estimate can be interpreted.
How should planning calculations be understood?
In general, sample-size planning asks how many participants or events might be needed to detect a specified effect under stated assumptions. Such calculations depend on choices about the effect of interest, the statistical method, and the level of uncertainty to tolerate. A planning illustration is not an observed result and is not evidence that a completed study had a particular probability of detecting an effect. The registry record does not report a sample-size justification for this trial. It also does not report an effect estimate on which a planning calculation could be based.
Over-dispersion is a general issue that arises when observed variability exceeds what a chosen statistical model assumes. Accounting for it can affect uncertainty estimates in settings where it applies. The registry record does not identify an over-dispersion analysis or provide data from which one could be evaluated. This general concept therefore does not supply a method or result for this trial.
The design assumptions attached to planning illustrations describe hypothetical calculations, not the trial's own analysis. Since the study is single group and no primary effect estimate is posted, such illustrations cannot turn the unavailable response outcome into evidence about efficacy. Any calculated planning scenario should be read as a design aid, not as observed power or as a finding from the study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists secondary outcomes that include median progression-free survival, treatment-related adverse events, and discontinuation due to treatment-related adverse events. Median progression-free survival appears repeatedly in the outcome list. The record does not explain whether these entries represent distinct assessments or how any multiple outcome testing would be handled. A multiplicity adjustment or testing hierarchy is not reported in the registry record.
In general, when several outcomes or hypotheses are tested, the chance of at least one apparently notable result can increase unless the analysis accounts for the multiple tests or clearly distinguishes primary from exploratory analyses. That is a general statistical concern, not evidence that any particular procedure was or was not used beyond what the registry reports. No analysis results are posted, so there are no secondary findings to interpret in relation to multiplicity.
The registry explicitly states that data were not collected because the study terminated before participants' assessment at the prespecified time points. It does not report an imputation method, a missing-data sensitivity analysis, or participant-level reasons for absent efficacy assessments. In general, missing outcomes can affect interpretation, and the consequences depend on why observations are missing and on the methods used to address them. Those details are not reported in the registry record.
The record does not define analysis populations, such as which participants would be included in the primary efficacy analysis, nor does it describe how evaluability was determined. The primary outcome description mentions participants evaluable for response measurement, but the record gives no evaluability count or response data. It therefore does not support a comparison between analysis populations or an assessment of how exclusions might affect the endpoint.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Pembrolizumab & Lenvatinib | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Pembrolizumab & Lenvatinib | 2 of 4 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Pembrolizumab & Lenvatinib | 4 of 4 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pembrolizumab & Lenvatinib |
|---|---|---|
| Fatigue | General disorders | 4 of 4 |
| Lymphocyte count decreased | Investigations | 4 of 4 |
| Hyperglycemia | Metabolism and nutrition disorders | 4 of 4 |
| Anemia | Blood and lymphatic system disorders | 3 of 4 |
| Nausea | Gastrointestinal disorders | 3 of 4 |
| Vomiting | Gastrointestinal disorders | 3 of 4 |
| Creatinine increased | Investigations | 3 of 4 |
| Platelet count decreased | Investigations | 3 of 4 |
| Anorexia | Metabolism and nutrition disorders | 3 of 4 |
| Hyperthyroidism | Endocrine disorders | 2 of 4 |
The registry's adverse-event group is Pembrolizumab and Lenvatinib. Its serious adverse event fields report 4 participants at risk and 0 affected. Its other adverse event fields report 4 at risk and 4 affected. The record also lists 2 deaths. These counts are the safety information available in the registry record; they do not supply event descriptions, timing, severity details beyond the serious-event classification, or participant-level circumstances.
The other adverse event count should not be restated as a count of treatment-related events. Although treatment-related adverse events appear among the listed secondary outcomes, the group counts do not establish causality or provide a result for that outcome. Likewise, the death count alone does not establish whether deaths were related to treatment, the cancer, or another cause. Those details are not reported in the registry record.
In general, adverse-event counts describe reported events or affected participants according to the outcome definition, and the denominator and observation period matter for interpretation. The registry gives the at-risk counts for these fields but does not provide a fuller account of exposure duration or event timing. The counts therefore should be read descriptively, not as a comparative estimate of safety.
12. What the Result Does, and Does Not, Mean
The record documents a phase 2, open-label, single-group study of lenvatinib plus pembrolizumab in Black participants with mismatch repair-proficient recurrent endometrial cancer. It specifies an objective response outcome at 24 weeks and a method for tumor response assessment, RECIST v1.1. It also records enrollment of 4 participants and a terminated status. These details establish what the study set out to examine and what the registry reports about its conduct.
The primary efficacy result is unavailable. The record attributes the absence of data to study termination before the prespecified assessment time points. As a result, the registry does not show whether participants met response criteria, and it does not quantify response or its precision. No conclusion about efficacy should be drawn from the absence of a posted result.
The safety fields provide limited descriptive counts, including 0 affected in the serious adverse event fields, 4 affected in the other adverse event fields, and 2 deaths. They do not establish why those events occurred or whether they were related to treatment. The posted record also lacks outcome details needed to interpret progression-free survival and the listed treatment-related adverse-event outcomes.
In general, results from a small single-group study can be informative descriptively but do not offer a controlled comparison. In this case, the missing primary outcome data make even a descriptive efficacy estimate unavailable. The record can therefore clarify the planned clinical question and identify the limits of the available results, but it cannot answer whether the combination changed clinical outcomes in the population studied.
13. Why This Trial Matters Statistically
This study is statistically notable because its intended primary endpoint and assessment framework are recorded, while the efficacy data needed to answer the endpoint question are not. The distinction between a specified outcome and an observed outcome is fundamental: defining objective response at 24 weeks using RECIST v1.1 does not create a response estimate when the required assessments were not completed or recorded.
The record also illustrates how termination can constrain interpretation. It reports enrollment of 4 participants and explains that data were not collected because the study ended before the prespecified assessment time points. Without those assessments, there is no primary estimate to compare with a benchmark, no precision measure for that estimate, and no basis for evaluating the planned efficacy question from the registry results.
The single-group design is another important statistical feature. A result from one group, if available, would describe outcomes in that group rather than provide a randomized treatment contrast. In this record, no efficacy result is available at all. Keeping those limitations distinct prevents both overstating what the design could show and mistaking missing evidence for a negative finding.
The listed adverse-event and death counts also illustrate why outcomes must be read according to their definitions. Counts alone do not establish causes, treatment relationships, or comparative risks. Overall, this trial record is useful for understanding the planned question, the design, and why a primary result is absent; it does not provide an estimate of treatment efficacy.
14. 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 most important trial-specific limitation is that the primary response data were not collected. The registry attributes this to termination before participants' prespecified assessments. No objective response rate, response count, or uncertainty interval is reported, so the primary endpoint cannot be evaluated from the posted results.
The study enrolled 4 participants and had a single-group, open-label design. With no comparator, the design could not provide a randomized between-group estimate. The limited enrollment also means the record offers little information about the range of outcomes in the target population, even apart from the missing primary endpoint. The registry does not state why the study was terminated or whether recruitment reached its planned target.
Important analysis details are not reported in the registry record. These include the sample-size justification, statistical analysis plan, analysis populations, missing-data methods, and any multiplicity approach. The record does not provide participant characteristics beyond the target population description, detailed event narratives, or the timing and causes of the deaths. It also does not provide results for the listed secondary outcomes.
The adverse-event fields should be interpreted cautiously because the record does not provide detailed definitions, event timing, or a treatment-causality breakdown for the group counts. The listed deaths cannot be attributed to treatment based on the available information. Taken together, the design, termination, unavailable efficacy assessments, and limited outcome detail prevent firm conclusions about efficacy or a comprehensive assessment of safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer — NCT05263492.
- Registry record last updated 2025-10-02; status last verified 2025-09.
- Results first posted 2025-10-02.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT05263492 is a multicenter, open-label phase 2, single-group study sponsored by Virginia Commonwealth University. It examined lenvatinib with pembrolizumab in Black participants with mismatch repair-proficient recurrent endometrial cancer. The registry describes lenvatinib at 20 mg orally once daily during each 21-day cycle and pembrolizumab at 200 mg by intravenous infusion on day 1 of each cycle.
The primary endpoint was objective response rate at 24 weeks, with tumor response assessed according to RECIST v1.1. The record lists a start date of 2022-04-01, a primary completion date of 2024-09-13, enrollment of 4, and terminated status. It states that efficacy data were not collected because termination occurred before participants' prespecified assessment time points. No primary efficacy result or analysis is reported. The safety fields list 0 affected for serious adverse events, 4 affected for other adverse events, and 2 deaths, without details sufficient to establish cause or treatment relationship.