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 Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302) (NCT03260894), a randomized phase 3 study. The primary outcome is Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03260894 |
| Phase | Phase 3 |
| Condition | Renal Cell Carcinoma (RCC) |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 129 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Incyte Corporation |
| Results posted | Yes |
2. Clinical Question
Population
Participants with locally advanced or metastatic renal cell carcinoma with a clear cell component who had not received prior systemic therapy for their mRCC. The primary outcome’s analysis population was the Intention-to-Treat population, defined as all randomized participants.
Intervention
Pembrolizumab plus epacadostat. The study was intended to evaluate the efficacy and safety of this combination as first-line treatment.
Comparator
Standard of care, consisting of sunitinib or pazopanib monotherapy. The registry record does not state how the choice between those comparator drugs was made.
Primary question
What was the objective response rate, defined as the percentage of participants with complete or partial response per RECIST v1.1 by investigator determination, for the combination compared with standard of care? The recorded timeframe was up to approximately 8 months. Numerical primary outcome results are not reported in the registry record.
This question is about response observed under the study’s stated assessment definition and timeframe. It is not, by itself, a question about how long a response lasted, how long participants lived without disease progression, or overall survival; those outcomes are not identified as the primary endpoint in the record. The study also listed safety and tolerability outcomes concerning adverse events and discontinuation due to adverse events. Those outcomes address different aspects of the comparison and should not be treated as substitutes for the primary response measure.
The randomized comparison is intended to assess differences between assigned treatment strategies. The open-label design means masking was absent. Investigator determination was specified for the primary endpoint, so the recorded response classification depended on investigator assessment. The registry record does not report further details about how response assessments were conducted or reviewed.
3. Trial Design
NCT03260894 is recorded as a randomized, open-label, Phase 3, parallel-group study sponsored by Incyte Corporation. Its title identifies the comparison as pembrolizumab plus epacadostat versus standard of care, defined as sunitinib or pazopanib, for first-line treatment of locally advanced or metastatic renal cell carcinoma. The brief description specifies participants with a clear cell component who had not received prior systemic therapy for their mRCC.
The registry record lists enrollment of 129. The recorded study start date is 2017-12-07, the primary completion date is 2018-08-22, and the status is completed. These dates describe the registry’s study milestones; they do not establish the length of treatment or follow-up for an individual participant.
The primary endpoint was objective response rate, expressed as the percentage of participants with complete or partial response according to RECIST v1.1 by investigator determination. The endpoint timeframe was up to approximately 8 months. The primary analysis population was the Intention-to-Treat population, defined in the record as all randomized participants. Numerical response results and an arm-by-arm account of the primary outcome are not reported in the registry record.
The record also names safety and tolerability outcomes based on participants experiencing adverse events and participants discontinuing study drug due to adverse events. It does not give numerical results for those secondary outcomes in the information described. The safety listing separately reports counts for serious adverse events, other adverse events, and deaths. Those counts can describe the posted safety information, but do not supply the missing primary efficacy comparison.
Although the study is described as randomized and parallel-group, the registry record does not report the allocation sequence method, allocation concealment, treatment duration, detailed follow-up schedule, or the method for choosing sunitinib versus pazopanib. It also does not report a protocol-level sample-size justification or detailed statistical analysis plan. The design labels alone cannot fill in those omissions.
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.
Before assignment: No new participants were enrolled after 02-MAY-2018. As the results did not meet statistical preplanned assumptions, the development of the combination therapy was stopped. At the time of discontinuation, participants were given the option to discontinue from the study or continue study treatment if they showed clinical benefit per investigators.
Overall Study
| Stage | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) |
|---|---|---|
| STARTED | 64 | 65 |
| Intention-to-Treat (ITT) | 64 | 65 |
| All Subjects as Treated (ASaT) | 64 | 63 |
| COMPLETED | 18 | 46 |
| NOT COMPLETED | 46 | 19 |
Reasons for not completing this period:
| Reason | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) |
|---|---|---|
| Death | 6 | 8 |
| Withdrawal by Subject | 4 | 11 |
| Transitioned to Pembrolizumab Monotherapy | 36 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Intention-to-Treat (ITT) population consisted of all randomized participants
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 Intention-to-Treat (ITT) population consisted of all randomized participants.
| Characteristic | Unit | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) | Total |
|---|---|---|---|---|
| Participants analysed | 64 | 65 | 129 | |
| Age, Continuous | years | 62.9 (SD 10.9) | 62.1 (SD 10.6) | 62.5 (SD 10.7) |
| Sex: Female, Male: Female | Participants | 20 | 15 | 35 |
| Sex: Female, Male: Male | Participants | 44 | 50 | 94 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 19 | 14 | 33 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 43 | 47 | 90 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 4 | 6 |
| Race/Ethnicity, Customized: American Indian Or Alaska Native | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Asian | Participants | 10 | 9 | 19 |
| Race/Ethnicity, Customized: White | Participants | 53 | 56 | 109 |
| ECOG Performance Scale: 0 | Participants | 41 | 35 | 76 |
| ECOG Performance Scale: 1 | Participants | 23 | 28 | 51 |
| ECOG Performance Scale: 2 | Participants | 0 | 2 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC), measured over up to approximately 8 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
Objective response rate is the percentage of participants who achieved either complete response or partial response under the stated assessment criteria. In this study, response was defined according to RECIST v1.1 and determined by investigators. The recorded timeframe was up to approximately 8 months, and the analysis population was the Intention-to-Treat population, defined as all randomized participants.
As a binary endpoint, each participant is classified according to whether the response definition was met during the specified assessment period. The percentage then describes the proportion classified as responders in the relevant analysis population. This kind of endpoint can provide a direct measure of tumor response under a prespecified definition, rather than relying on a continuous measurement of change.
Response rate does not, on its own, describe the duration of response or the timing of progression. Nor does it establish an effect on survival. Those are distinct outcomes and require their own definitions and analyses. A response result also depends on how assessments are scheduled, how missing or unevaluable assessments are handled, and whether response classification is made consistently. The registry record does not report those operational details beyond the stated RECIST v1.1 definition and investigator determination.
The record identifies the endpoint but does not report the response counts, percentages, confidence intervals, or a numerical comparison between treatment groups. Therefore, the endpoint’s definition can be described, but its observed result and precision cannot be assessed from the registry information recorded.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the clinical comparison and defines the primary outcome, but it does not report numerical objective response results. Consequently, no conclusion about the observed response rate in either group, the size or direction of a difference, or the precision of that comparison can be drawn from the recorded primary outcome information. The outcome title and definition are not themselves evidence of a treatment effect.
The study was randomized, which is a design feature intended to support a fair comparison of assigned strategies. Randomization does not guarantee that groups will be identical in every characteristic, and the registry information does not give baseline characteristics with which to assess their balance. The study was open-label, so participants and investigators were not masked according to the masking field. Because response was determined by investigators, the record’s stated assessment method should be kept in mind when interpreting any response figures; no further safeguards or independent review procedures are reported.
The Intention-to-Treat population is defined as all randomized participants. In general, an Intention-to-Treat approach retains participants in the groups to which they were randomized, which can preserve the intended basis for comparison. The record does not describe how missing, unevaluable, or incomplete response assessments were treated, however. It is therefore not possible to determine from this information how such cases affected the endpoint analysis.
Safety information is reported separately from the primary efficacy endpoint. The listed counts include participants with serious adverse events, other adverse events, and deaths in each treatment group. These are descriptive safety figures; the registry information does not establish that every event was caused by study treatment. The serious adverse event terms are listed with percentages, but the information does not state whether each term’s percentage is arm-specific. They should not be interpreted as a direct comparison between treatments without that context.
The registry record reports zero listed analyses. It also does not report a numerical primary result, confidence interval, hypothesis test, or adjusted analysis. Thus, there is no posted estimate from which to assess effect magnitude or statistical uncertainty. A confidence interval, when available, describes a range of values compatible with the data under the analysis assumptions; it can help distinguish a precise estimate from one with substantial uncertainty. No such interval for the primary outcome is reported in the registry information.
The record includes assumptions for a planning illustration based on an observed effect, but that illustration is not the trial’s own design justification and is not observed power. Since no primary effect estimate is reported in the registry information, the illustration should not be used as evidence about the trial’s observed outcome. The registry record does not report the original sample-size rationale, interim analyses, or a detailed statistical plan. The absence of these details limits assessment of how the trial was planned and how the reported outcomes were intended to be analyzed.
9. Statistical Methods Explained
Statistical methods help translate participant-level observations into estimates that can be compared between groups. For this study, the primary endpoint is a percentage based on whether participants met a response definition. The registry record specifies the response criteria and analysis population, but it does not provide the observed primary results or a detailed account of the analysis procedure. General explanations below describe the concepts involved, not additional details about the trial’s conduct.
What does a response percentage represent?
For a binary outcome, each participant is classified into one of two categories for the endpoint: meeting or not meeting the response definition. The percentage is the fraction of the analysis population classified as meeting that definition, expressed on a percentage scale. Here, the stated categories qualifying as response were complete response and partial response under RECIST v1.1, as determined by investigators. The percentage is meaningful only alongside a clear definition of who is included, what counts as an event, and the period in which the event is assessed.
A percentage alone does not show how stable an estimate might be. Estimates from smaller groups tend to have more sampling uncertainty than estimates from larger groups, all else being equal. A confidence interval communicates uncertainty around an estimate by giving a range of values compatible with the data and the method used. Its interpretation relies on the analysis assumptions; it is not a guarantee that a particular range contains the true value. The registry record identifies a 95% Confidence Interval as the primary outcome’s dispersion measure, but numerical response estimates and intervals are not reported in the information described.
Why does the analysis population matter?
The primary population is the Intention-to-Treat population, defined in the registry record as all randomized participants. In general, retaining participants according to their randomized assignment can preserve the comparison created by randomization. The practical consequences depend on the analysis rules, including how participants with no evaluable assessment are handled. The record does not report those rules, so it is not possible to say whether missing assessments were counted as nonresponse, excluded, imputed, or treated in another way.
Other analysis populations can answer different questions, but the registry information described does not identify additional primary analysis populations or provide analysis-specific results. The population definition should therefore be read as the stated basis for the primary endpoint, not as proof that every randomized participant contributed an observed response classification.
What does randomization contribute?
Randomization assigns participants to treatment groups by chance. In general, its purpose is to reduce systematic differences between groups at assignment and to support interpretation of outcome contrasts as comparisons of assigned strategies. It does not ensure that all participant characteristics are identical between groups, especially in a finite study. Baseline information and details of the randomization procedure would help readers assess implementation, but those details are not reported in the registry record.
The study is recorded as open-label, with no masking. Lack of masking can matter for outcomes involving judgment or behavior. The endpoint was determined by investigators, according to the record. This does not establish that assessment was biased, but it makes information about assessment procedures relevant. The registry record does not report independent central review, assessor training, or other details that would clarify how investigator determination was applied.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when observed variation is greater than a model assumes. If a model understates variability, standard errors may be too small and confidence intervals may be too narrow, making evidence appear more precise than it is. The suitable model depends on the outcome and data structure. The primary endpoint is a binary response summarized as a percentage; the registry information does not state that an over-dispersion adjustment was used or needed. No particular modeling approach should be inferred from the endpoint definition alone.
How should planning illustrations be read?
The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. For outcomes other than time-to-event outcomes, the illustration is expressed as participants per arm. These are planning assumptions, not evidence that the study was designed using those assumptions. The record explicitly distinguishes the illustration from the trial’s own design.
In general, a sample-size calculation estimates how many participants would be needed under specified assumptions to detect a chosen effect with a chosen probability of statistical significance. Its result depends on the assumed effect, variability, significance level, allocation, and analysis method. A planning illustration is not an observed result, and it must not be described as observed power. Since the registry information does not report the primary numerical effect, the illustration cannot be used to characterize the observed response comparison.
What does a statistical test add?
General explanation: a hypothesis test evaluates how compatible the observed data are with a specified null hypothesis under stated assumptions. A p-value is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect. Confidence intervals and effect estimates are needed to understand magnitude and precision. No primary p-value, effect estimate, or confidence interval is reported in the registry information, so a formal statistical interpretation of the primary comparison is unavailable.
The registry record lists no analyses. This does not identify which statistical procedures, if any, were used in other study documents or publications; those details are not reported in the registry record. A complete methods assessment would need the prespecified analysis plan, outcome handling rules, and numerical results, none of which can be reconstructed from the endpoint definition alone.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when several outcomes, comparisons, or repeated tests are considered. In general, conducting many tests without an appropriate plan can increase the chance of obtaining at least one apparently unusual result by chance. A prespecified hierarchy, adjustment method, or other strategy can address this issue, but the suitable approach depends on the study’s objectives and analysis plan.
The registry record lists the primary objective response endpoint and safety outcomes concerning adverse events and discontinuation due to adverse events. It does not report a multiplicity strategy, a testing hierarchy, or whether any adjustment was planned. The record also lists zero analyses. No particular approach to multiplicity should be inferred from the outcome list alone.
Missing-data handling is also not reported in the registry record. For a response endpoint, missing or unevaluable assessments can affect the denominator and the classification of response. Different rules can lead to different estimates, so readers would need the analysis plan and outcome accounting to understand the impact. The Intention-to-Treat population is defined as all randomized participants, but that definition does not specify how unavailable response assessments were handled.
The primary analysis population is identified as all randomized participants. The registry record does not describe additional analysis populations, deviations from assigned treatment, or sensitivity analyses. It also does not report interim analyses, stopping rules, or a detailed statistical plan. These omissions mean that the available information cannot establish how multiplicity, missing observations, or analysis-population decisions were handled in the trial’s statistical analyses.
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 + Epacadostat | 18 | 64 | 28.1% |
| SoC (Sunitinib or Pazopanib) | 15 | 63 | 23.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Pembrolizumab + Epacadostat | 8 of 64 |
| SoC (Sunitinib or Pazopanib) | 8 of 65 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Pembrolizumab + Epacadostat | 61 of 64 |
| SoC (Sunitinib or Pazopanib) | 61 of 63 |
Most frequent serious adverse event terms
| Event term | Organ system | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) |
|---|---|---|---|
| Hyponatraemia | Metabolism and nutrition disorders | 1 of 64 | 2 of 63 |
| Atrial fibrillation | Cardiac disorders | 1 of 64 | 1 of 63 |
| Pneumonia | Infections and infestations | 2 of 64 | 0 of 63 |
| Hypercalcaemia | Metabolism and nutrition disorders | 2 of 64 | 0 of 63 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 1 of 64 | 1 of 63 |
| Acute coronary syndrome | Cardiac disorders | 1 of 64 | 0 of 63 |
| Cardiac failure | Cardiac disorders | 0 of 64 | 1 of 63 |
| Pericardial effusion | Cardiac disorders | 0 of 64 | 1 of 63 |
| Adrenal insufficiency | Endocrine disorders | 1 of 64 | 0 of 63 |
| Diarrhoea | Gastrointestinal disorders | 0 of 64 | 1 of 63 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 13 of 64 | 30 of 63 |
| Nausea | Gastrointestinal disorders | 22 of 64 | 20 of 63 |
| Hypertension | Vascular disorders | 7 of 64 | 23 of 63 |
| Fatigue | General disorders | 12 of 64 | 15 of 63 |
| Anaemia | Blood and lymphatic system disorders | 10 of 64 | 12 of 63 |
| Alanine aminotransferase increased | Investigations | 8 of 64 | 14 of 63 |
| Decreased appetite | Metabolism and nutrition disorders | 10 of 64 | 12 of 63 |
| Hypothyroidism | Endocrine disorders | 9 of 64 | 12 of 63 |
| Aspartate aminotransferase increased | Investigations | 4 of 64 | 16 of 63 |
| Back pain | Musculoskeletal and connective tissue disorders | 10 of 64 | 9 of 63 |
Serious events with the highest arm-level rate: hyponatraemia (3.2%), pneumonia (3.1%), hypercalcaemia (3.1%), atrial fibrillation (1.6%), cardiac failure (1.6%).
The safety listing reports 18 participants with serious adverse events among 64 at risk in the pembrolizumab plus epacadostat group, and 15 among 63 at risk in the standard-of-care group. For other adverse events, the listing reports 61 participants among 64 at risk in the combination group and 61 among 63 at risk in the standard-of-care group. Deaths are listed as 8 in each group. These are counts as recorded; no rates have been calculated from them.
The serious adverse event terms listed with percentages are hyponatraemia, 3.2%; pneumonia, 3.1%; hypercalcaemia, 3.1%; atrial fibrillation, 1.6%; cardiac failure, 1.6%; and pericardial effusion, 1.6%. The registry information described does not state whether these term percentages are specific to an arm, so they should not be assigned to either group or used as arm-to-arm comparisons.
Adverse event counts describe events recorded during the study and do not, by themselves, establish causation. They also do not convey event timing, duration, severity beyond the serious-event classification, or exposure-adjusted comparisons. The registry record does not provide those details in the information described. The separately named secondary outcomes include safety and tolerability measured by participants experiencing adverse events and participants discontinuing study drug due to adverse events, but their numerical results are not reported in the registry information.
12. What the Result Does, and Does Not, Mean
The registry record supports a description of the trial question, design labels, endpoint definition, and some safety counts. It does not report numerical results for the primary objective response endpoint. As a result, the response comparison cannot be interpreted for direction, magnitude, or statistical precision from this record alone. A title stating that the trial evaluated efficacy and safety does not substitute for its numerical findings.
The primary endpoint was defined as the percentage of participants with complete or partial response per RECIST v1.1 by investigator determination, in the Intention-to-Treat population, over a timeframe up to approximately 8 months. That definition tells readers what the intended outcome represents. It does not show how many participants responded, how the groups compared, or how uncertain any estimate would be.
The safety counts provide descriptive information about participants recorded with serious adverse events, other adverse events, and deaths. They do not establish that an event was caused by treatment, and they do not describe the full clinical context needed for a comparative safety assessment. The serious adverse event term percentages are listed without arm attribution in the registry information described, so they should not be read as group-specific results.
The study’s randomized design is relevant to the intended comparison, while its open-label status and investigator-determined endpoint are relevant features of outcome assessment. Neither feature alone determines the validity or direction of a result. Assessing how they affected the findings would require detailed methods and numerical results, which are not reported in the registry record.
Accordingly, the record can establish what was studied and how the primary endpoint was defined, but not whether the combination had a higher, lower, or similar response rate than standard of care. It also cannot support conclusions about response duration, progression, survival, or comparative treatment effects on the listed secondary safety outcomes from the information described.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why a registry’s study question and outcome definition must be distinguished from its results. The record describes a randomized, open-label, Phase 3 comparison and specifies objective response rate as the primary endpoint. Yet without the numerical endpoint results, the comparison’s estimated size and uncertainty cannot be assessed. Design labels and endpoint wording alone do not answer the efficacy question.
The endpoint is a percentage based on a defined response category. Interpreting such an outcome requires more than a percentage: readers need the analysis population, the counts underlying each estimate, uncertainty intervals, and clear rules for assessments that are missing or unevaluable. The registry record defines the Intention-to-Treat population and response criteria, but does not report the primary estimates or the missing-data rules described in a detailed analysis plan.
The record also illustrates the difference between a planning calculation and a trial’s actual design rationale. Its sample-size assumptions describe a planning illustration based on an observed effect; they are not the trial’s own design justification and are not observed power. Keeping that distinction clear prevents a hypothetical planning result from being mistaken for evidence about the trial’s outcome or adequacy.
Finally, the safety listing and primary endpoint answer different questions. Safety counts can be read descriptively, while the primary response outcome would require its own treatment-group estimates and measures of precision. This separation matters because a study’s efficacy and safety evidence cannot be reduced to a single number or inferred from the trial title. The statistical value of a registry record depends on both its design information and the completeness of its posted results.
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 main limitation for interpretation is that the registry record described does not report numerical results for the primary endpoint. Without response estimates, confidence intervals, or a comparison between groups, the primary objective cannot be assessed quantitatively. The record identifies the outcome definition and timeframe, but those details do not reveal the observed findings.
The registry information does not report the detailed statistical analysis plan, sample-size justification, handling of missing or unevaluable response assessments, interim analyses, or multiplicity strategy. It also does not describe allocation concealment, the process for choosing between sunitinib and pazopanib, or further procedures for investigator-determined response assessment. These details would be needed for a fuller evaluation of design and analysis.
The trial is recorded as open-label, and the primary outcome was determined by investigators. This is relevant context for an endpoint involving assessment, but the available record does not provide enough information to determine how assessment procedures may have influenced classification. No conclusion about bias should be drawn from that design feature alone.
The safety data are limited to the counts and serious adverse event terms recorded. The information described does not give numerical results for the named secondary outcomes concerning adverse events and discontinuation due to adverse events. Nor does it provide the event timing, duration, exposure context, or arm attribution for the listed serious adverse event term percentages. Those omissions restrict comparative interpretation of safety.
The registry record is marked completed, but completion status does not supply missing efficacy results or clarify the methods used. The limitations above concern the information reported in the registry record; they do not establish whether additional details exist elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302) — NCT03260894.
- Registry record last updated 2026-05-22; status last verified 2026-04.
- Results first posted 2019-09-10.
- 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
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18. Record Summary
NCT03260894 is a randomized, open-label, Phase 3 parallel-group study sponsored by Incyte Corporation. It compared pembrolizumab plus epacadostat with standard of care, defined as sunitinib or pazopanib, for first-line treatment of locally advanced or metastatic renal cell carcinoma with a clear cell component in participants without prior systemic therapy for mRCC.
The record lists enrollment of 129, a start date of 2017-12-07, a primary completion date of 2018-08-22, and completed status. The primary endpoint was objective response rate per RECIST v1.1 by investigator determination, in the Intention-to-Treat population, with a timeframe up to approximately 8 months.
Numerical primary endpoint results are not reported in the registry record. Safety listings include serious adverse events, other adverse events, deaths, and serious adverse event terms with percentages. The registry information described does not provide a detailed statistical plan, missing-data rules, multiplicity strategy, or numerical results for the named secondary safety outcomes.