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 Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma (NCT04209686), a non-randomized phase 2 study. The primary outcome is Overall Survival (OS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04209686 |
| Phase | Phase 2 |
| Condition | Advanced Gastric Adenocarcinoma |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Results posted | Yes |
2. Clinical Question
Population
People with previously treated advanced gastric adenocarcinoma. The registry distinguishes an arm for measurable disease from an arm for unmeasurable disease. For the primary overall-survival evaluation, it says that only patients who received at least one dose of all three study drugs are evaluable. In Arm 1, 15/18 patients received the three-drug combination.
Intervention
The combination of paclitaxel, pembrolizumab and olaparib. The registry describes the study purpose as evaluating the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced gastric cancer.
Comparator
There is no randomized control group. The study is recorded as non-randomized, with parallel arms defined by measurable versus unmeasurable disease. Those arms are not a like-for-like control comparison, so differences between them would not establish a comparative treatment effect.
Primary question
The primary endpoint is overall survival, measured from the start of the first dose of study drug to death or the end of follow-up. The registry specifies estimation using the Kaplan-Meier curve, but does not report an overall-survival estimate, confidence interval or hazard ratio.
The study therefore asks about survival and safety in a selected group receiving the three-drug regimen, rather than whether the regimen outperforms a randomized alternative. The record lists 19 participants enrolled and describes two disease-measurability arms. Arm 1 includes patients with measurable disease; Arm 2 includes patients with unmeasurable disease. Because allocation was not randomized and the arms represent different disease-measurability groups, they should not be interpreted as equivalent treatment groups for an efficacy comparison.
The registry also names grade 3 or above study-drug-related adverse events and immune-related adverse events as secondary outcomes. It does not provide their outcome results in the record. Consequently, the stated study purpose and endpoint definitions identify what investigators intended to assess, but the posted record does not allow a quantitative judgment about survival or these secondary outcomes.
3. Trial Design
This is a Phase 2, non-randomized, open-label, parallel study sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registry lists an enrollment of 19 and a completed status. The recorded start date is 2020-07-31, and the primary completion date is 2025-11-17. The study concerns previously treated advanced gastric adenocarcinoma.
The intervention is paclitaxel, olaparib and pembrolizumab. The registry identifies Arm 1 as measurable disease and Arm 2 as unmeasurable disease. It does not provide further arm descriptions. The disease-measurability labels distinguish the groups, but the record does not present them as randomized treatment alternatives. Since allocation is non-randomized, and the arms differ by disease measurability, an arm-to-arm contrast would not be a like-for-like control comparison.
The primary outcome is overall survival, with a timeframe stated as up to 27 months. The endpoint description defines the time origin as the start of the first dose of study drug and the event as death. For participants without documentation of death at analysis, the description says survival is censored on the date they were last known to be alive. The registry says estimation is based on the Kaplan-Meier curve. The primary-outcome population is restricted to patients who received at least one dose of all three study drugs; for Arm 1, the record states that 15/18 patients did so.
The registry lists adverse events as secondary outcomes, including grade 3 or above study-drug-related adverse events and immune-related adverse events. It reports 0 analyses. An analysis plan, sample-size justification, interim-analysis details and a rationale for the enrollment target are not reported in the registry record. The available record therefore establishes the broad design and endpoint definitions but does not describe the statistical plan in enough detail to assess how the study was intended to estimate clinical activity or handle the secondary outcomes.
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 | Cohort 1 - Measurable Disease | Arm 2: Cohort 2-Unmeasurable Disease |
|---|---|---|
| STARTED | 18 | 1 |
| COMPLETED | 18 | 1 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Only patients who received at least one dose of all three study drugs are evaluable for the OS. In Arm 1, 15/18 patients received the three-drug combination.
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.
| Characteristic | Unit | Cohort 1 - Measurable Disease | Cohort 2-Unmeasurable Disease | Total |
|---|---|---|---|---|
| Participants analysed | 18 | 1 | 19 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 12 | 1 | 13 |
| Age, Categorical: >=65 years | Participants | 6 | 0 | 6 |
| Sex: Female, Male: Female | Participants | 7 | 1 | 8 |
| Sex: Female, Male: Male | Participants | 11 | 0 | 11 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 17 | 1 | 18 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 14 | 1 | 15 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 18 | 1 | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival (OS), measured over Up to 27 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
Overall survival is the time from the start of the first dose of study drug until death or the end of follow-up. For a participant without documented death at the time of analysis, the endpoint description specifies censoring at the date the participant was last known to be alive. This allows follow-up information from people who have not had a recorded death to contribute up to their last known alive date, without treating that date as a death.
In general, overall survival is a time-to-event endpoint: it accounts for both whether the event occurred and how long participants were followed before the event or censoring. The registry specifies the Kaplan-Meier curve for estimating survival. In general, this method uses observed event times and accommodates censored follow-up, subject to assumptions about the censoring process. The registry record does not report the curve, a median survival estimate or its 95% confidence interval.
The stated timeframe is up to 27 months. The endpoint population is limited to patients who received at least one dose of all three study drugs. The record specifically states that, in Arm 1, 15/18 patients received the combination. This eligibility rule matters when interpreting who contributes to the reported endpoint: it is not described as including every enrolled participant regardless of treatment received.
Overall survival is used in clinical studies because death is a clearly defined event and the measure summarizes time from a specified starting point to that event. Its interpretation still depends on follow-up, censoring and the population analyzed. In this record, the endpoint definition is available, but the numerical result and associated precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes the design and primary endpoint but does not report an overall-survival result. It gives no median overall-survival estimate, 95% confidence interval, hazard ratio or statistical test result. The registry records 0 analyses. Thus, the posted record does not support a numerical interpretation of survival, nor does it show the precision of any survival estimate.
The recorded study is non-randomized and has parallel arms defined by measurable and unmeasurable disease. Those arms are not a randomized comparison and should not be treated as equivalent groups differing only in treatment. Disease measurability itself distinguishes the groups. Any observed difference between them could reflect differences in the populations, rather than an effect of treatment. The registry record does not report an adjusted comparison or sponsor-reported hazard ratio.
The study enrolled 19 participants. For the primary endpoint, the record says that only patients who received at least one dose of all three study drugs are evaluable; in Arm 1, 15/18 patients received all three. This distinction is relevant to the analysis population. It also means that enrollment and the primary-endpoint population are not necessarily identical. The record does not describe the corresponding treatment-received count for Arm 2 in the primary endpoint description.
In general, an estimate without an interval gives limited information about precision. A confidence interval communicates a range of values compatible with the data under the analysis assumptions; it is not reported for the primary result in this registry record. Likewise, a point estimate alone would not show whether the observed data are highly uncertain. Here, even the point estimate is not reported, so no conclusion about the magnitude or uncertainty of survival can be drawn from the posted results.
The record names safety and clinical activity as study purposes and lists secondary outcomes for grade 3 or above study-drug-related adverse events and immune-related adverse events. It does not report results for those secondary outcomes. The serious-adverse-event group counts are available, but these are not a substitute for the listed secondary outcomes: the categories and definitions are not stated to be identical. The registry also lists deaths by arm in its adverse-event information, but without a reported survival analysis these counts should not be used to infer a median survival or a treatment effect.
Sample-size planning illustrations, when based on an observed effect, are not observed power and do not replace the trial’s own design rationale. The record does not report a sample-size justification or the sponsor’s survival estimate. No planning result can therefore clarify the strength of evidence from the posted registry results.
9. Statistical Methods Explained
The registry identifies overall survival as the primary outcome and describes a Kaplan-Meier estimate. It does not report a numerical survival estimate or any analysis result. The concepts below explain the stated methods in general; they do not establish what additional methods were used in this study.
What does a time-to-event outcome measure?
In general, a time-to-event outcome records the time from a defined origin to an event of interest. Here, the registry defines the origin as the start of the first dose of study drug and the event as death. Participants may have different lengths of follow-up, so a time-to-event approach can use information up to the event or the last time a participant is known to be alive.
The record calls for censoring participants without documentation of death at the date they were last known to be alive at analysis. In general, censoring means the event time is not observed during the available follow-up; it does not mean that the participant experienced the event at the censoring date. The method depends on appropriate handling of censoring. The registry’s description does not provide further details about follow-up completeness or assumptions.
What does Kaplan-Meier estimation do?
In general, the Kaplan-Meier method estimates the probability of remaining event-free over time while incorporating observed event times and censored observations. It creates a stepwise survival curve. The curve can be used to describe survival over follow-up and, if sufficiently many events occur, to estimate a median survival time. The registry identifies this method but does not give the curve, median or confidence interval, so those quantities cannot be interpreted from the record.
A confidence interval describes statistical uncertainty around an estimate under the assumptions of the analysis. The primary endpoint is said to use a 95% confidence interval as its dispersion measure, but a numerical interval is not reported. Without the estimate and interval, the direction, magnitude and precision of the survival result are unavailable.
Why does the analysis population matter?
The endpoint description says that only participants who received at least one dose of all three study drugs are evaluable for overall survival. This is an analysis-population definition tied to treatment receipt. In general, a clearly defined population helps readers understand which participants contribute to an estimate and what question that estimate addresses. A population restricted by treatment received may differ from the full enrolled group. The registry does not report additional analysis-population definitions or explain how participants who did not receive all three drugs were handled in other analyses.
The record states that 15/18 patients in Arm 1 received the three-drug combination. It does not give the corresponding count for Arm 2 in the primary endpoint description. This limits the detail available for evaluating endpoint eligibility across the two arms. The arm descriptions themselves provide only the measurable versus unmeasurable disease labels.
Why is the design relevant to interpretation?
In general, randomization helps balance measured and unmeasured characteristics between comparison groups. This study is explicitly non-randomized, and its arms are defined by disease measurability. Accordingly, they are not like-for-like control groups. A descriptive comparison between these arms would not isolate a treatment effect. The record does not report an adjusted comparison, and it states that no analyses are listed.
The study is open-label, meaning the masking field records none. In general, lack of masking can influence assessments or decisions when outcomes involve judgment. Death is a comparatively clear endpoint, but the record does not provide enough detail to assess whether or how lack of masking affected follow-up, treatment exposure or other outcomes.
What can planning calculations say?
In general, a sample-size calculation describes the amount of information a planned design might need to detect a specified effect under stated assumptions. Such calculations depend on the chosen effect, significance level, allocation, statistical approximation and, for time-to-event outcomes, event assumptions. A calculation based on an observed effect is a planning illustration, not evidence that the study had a particular probability of detecting an effect. It is not observed power.
The registry record does not report the trial’s own sample-size justification. It also does not report a sponsor-derived hazard ratio for the primary endpoint. The record’s general sample-size assumptions describe a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation, with a stated fraction of an observed effect as the target. For time-to-event calculations, it describes total events using the Schoenfeld method. These assumptions do not establish that this non-randomized study used that design for its own planning, and no planning result should be read as an observed trial outcome.
Over-dispersion is a general statistical issue in count outcomes: it occurs when variation exceeds what a simple count model assumes. Accounting for it can affect uncertainty estimates. The registry does not identify a count model or report an over-dispersion assessment for the listed adverse-event outcomes. Similarly, the analysis plan, interim analyses and multiplicity procedures are not reported in the registry record. No particular method for these matters can be attributed to the study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists overall survival as the primary outcome and names two secondary outcomes: the number of participants experiencing grade 3 or above study-drug-related adverse events and the number experiencing immune-related adverse events. It does not report results for those secondary outcomes. It also records 0 analyses. Details of the statistical analysis plan are not reported in the registry record.
In general, multiplicity arises when several outcomes or statistical tests are considered. Without an adjustment or a prespecified hierarchy, repeated testing can increase the chance of a false-positive finding. The registry record does not report whether multiplicity was addressed, how secondary outcomes were to be analyzed, or whether interim analyses were planned. No particular approach should be assumed.
The primary endpoint description specifies censoring at the last date a participant was known to be alive when death is not documented at analysis. It does not describe other missing-data handling, completeness of follow-up, or reasons for missing information. In general, censoring and missingness are not interchangeable: censoring is part of the stated time-to-event definition, while missing-data procedures concern information that is absent from an analysis. The record does not provide enough detail to evaluate either issue beyond its censoring statement.
The primary endpoint population includes only patients who received at least one dose of all three study drugs. For Arm 1, 15/18 patients met that treatment-receipt description. The registry does not state additional analysis populations, the handling of participants outside this definition, or the corresponding treatment-receipt count for Arm 2 in the primary outcome description.
These gaps matter because analysis populations, missing-data methods and multiplicity procedures can affect what estimates mean and how their uncertainty should be understood. With no reported analyses or outcome estimates, the registry record does not permit evaluation of those choices or of their impact on the findings.
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 |
|---|---|---|---|
| Arm 1: Measurable Disease | 13 | 18 | 72.2% |
| Arm 2: Unmeasurable Disease | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm 1: Measurable Disease | 17 of 18 |
| Arm 2: Unmeasurable Disease | 1 of 1 |
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 |
|---|---|
| Arm 1: Measurable Disease | 18 of 18 |
| Arm 2: Unmeasurable Disease | 1 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm 1: Measurable Disease | Arm 2: Unmeasurable Disease |
|---|---|---|---|
| Disease progression | General disorders | 3 of 18 | 0 of 1 |
| Thromboembolic event | Vascular disorders | 3 of 18 | 0 of 1 |
| Abdominal pain | Gastrointestinal disorders | 2 of 18 | 0 of 1 |
| Sepsis | Infections and infestations | 2 of 18 | 0 of 1 |
| Small intestinal obstruction | Gastrointestinal disorders | 2 of 18 | 0 of 1 |
| Delirium | Psychiatric disorders | 1 of 18 | 0 of 1 |
| Diarrhea | Gastrointestinal disorders | 1 of 18 | 0 of 1 |
| Edema cerebral | Nervous system disorders | 1 of 18 | 0 of 1 |
| Fever | Investigations | 1 of 18 | 0 of 1 |
| Fracture | Injury, poisoning and procedural complications | 1 of 18 | 0 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm 1: Measurable Disease | Arm 2: Unmeasurable Disease |
|---|---|---|---|
| Weight loss | Investigations | 12 of 18 | 1 of 1 |
| Anorexia | Metabolism and nutrition disorders | 11 of 18 | 0 of 1 |
| Fatigue | General disorders | 9 of 18 | 1 of 1 |
| Nausea | Gastrointestinal disorders | 8 of 18 | 1 of 1 |
| Vomiting | Gastrointestinal disorders | 7 of 18 | 1 of 1 |
| Abdominal pain | Gastrointestinal disorders | 7 of 18 | 0 of 1 |
| Cough | Respiratory, thoracic and mediastinal disorders | 6 of 18 | 1 of 1 |
| Headache | Nervous system disorders | 6 of 18 | 1 of 1 |
| Peripheral sensory neuropathy | Nervous system disorders | 6 of 18 | 1 of 1 |
| Alopecia | Skin and subcutaneous tissue disorders | 5 of 18 | 1 of 1 |
Serious events with the highest arm-level rate: disease progression (16.7%), thromboembolic event (16.7%), abdominal pain (11.1%), sepsis (11.1%), small intestinal obstruction (11.1%).
The registry’s adverse-event information lists Arm 1 with 18 participants at risk for serious adverse events and 13 affected, and Arm 2 with 1 at risk and 0 affected. It also lists 18 and 1 participants, respectively, at risk for other adverse events, with all 18 in Arm 1 and the 1 in Arm 2 affected. These are participant counts in the registry’s adverse-event grouping; they are not the results for the separately named secondary outcomes unless the definitions coincide, which the record does not establish.
The registry lists deaths as 17 in Arm 1 and 1 in Arm 2. These counts are not an overall-survival estimate. They do not provide the timing of deaths, account for follow-up through a survival curve, or indicate the precision of a survival estimate.
Among the listed serious-event terms, disease progression and thromboembolic event are each reported as 16.7%; abdominal pain, sepsis and small intestinal obstruction are each 11.1%; and delirium is 5.6%. These are registry-listed percentages for event terms. They should not be added together or interpreted as mutually exclusive categories, since the record does not specify that the terms represent distinct participants. A participant may be represented by more than one event term.
The adverse-event counts describe what is posted, not a randomized safety comparison. The arms differ by disease measurability, and the registry states that allocation was non-randomized. The record does not provide enough detail to infer comparative risk or attribute an event to a particular drug beyond the definitions stated for the listed categories.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed Phase 2 study evaluated paclitaxel, pembrolizumab and olaparib in previously treated advanced gastric adenocarcinoma, with overall survival as the primary endpoint and adverse events among the secondary outcomes. It gives the survival endpoint definition, the Kaplan-Meier method named for estimation, the treatment-receipt criterion for endpoint evaluability, and selected adverse-event counts.
It does not report an overall-survival estimate, a 95% confidence interval, a hazard ratio or a statistical test result. It also does not report results for the named secondary outcomes. Therefore, the posted registry information does not quantify survival or describe the precision of a survival estimate. The existence of a completed study and a defined endpoint is not itself evidence of a particular outcome.
The design also limits what can be learned from comparisons between arms. Allocation is non-randomized, and the arms represent measurable versus unmeasurable disease. They are not equivalent control groups. Differences between them cannot be interpreted as an isolated effect of the three-drug regimen.
In general, a study’s result applies most directly to its analyzed population and design. Here, the registry says that overall-survival evaluability requires receipt of at least one dose of all three study drugs, and gives the Arm 1 count as 15/18. It does not provide all analysis-population details. Nor does the record give a sample-size justification, interim-analysis information, or a statistical analysis plan that would clarify how outcomes were to be assessed.
The serious-adverse-event counts and event-term percentages are descriptive registry entries. They do not replace a full safety analysis and do not establish comparative safety between these non-randomized arms. Overall, the record provides trial structure and selected safety information, but not the primary or secondary outcome results needed to characterize clinical activity or statistical uncertainty.
13. Why This Trial Matters Statistically
This study is statistically notable because its primary outcome is a time-to-event measure, while the registry record gives no numerical survival result. A careful reading distinguishes the definition of an endpoint from its observed estimate. The endpoint is specified as time from first dose to death or end of follow-up, with censoring for participants last known alive, and estimation by Kaplan-Meier. Yet the result and its precision are not reported. That distinction prevents design details from being mistaken for evidence about the outcome.
The non-randomized design also shapes interpretation. The two arms are defined by measurable versus unmeasurable disease, not by randomized assignment to competing treatments. This means an arm contrast would not provide a like-for-like treatment comparison. Recognizing that limitation is important even when a study reports descriptive outcomes, because groups with different defining characteristics may not be comparable.
The endpoint population is another key statistical detail. The registry limits overall-survival evaluability to patients who received at least one dose of all three drugs and reports 15/18 in Arm 1 meeting that description. Readers need to distinguish this population from total enrollment and understand how treatment receipt relates to the analysis. The record does not describe all such details.
Finally, the listed adverse-event counts are not the same as a complete analysis of the secondary outcomes. The registry does not report their results, multiplicity procedures, missing-data methods or a statistical analysis plan. These omissions are not evidence that a method was or was not used; they mean it is not reported in the registry record. Together, these points show why statistical interpretation depends on estimates, uncertainty, population definitions and design—not merely on an endpoint label or study completion status.
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 consequential limitation of the registry record for statistical interpretation is that it does not report the primary overall-survival estimate or its 95% confidence interval. It records 0 analyses and provides no sponsor-reported hazard ratio. Without those results, survival magnitude and precision cannot be assessed from the posted record.
The study is non-randomized, and its parallel arms are distinguished by measurable versus unmeasurable disease. They are therefore not a like-for-like control comparison. The registry does not report an adjusted comparative analysis. Even if arm-specific outcomes were available, differences could not be attributed to treatment alone on the basis of this design.
The primary endpoint population is restricted to participants who received at least one dose of all three study drugs. The record gives the Arm 1 treatment-receipt count as 15/18 but does not give the corresponding count for Arm 2 in the endpoint description. Additional analysis populations and handling of participants outside the stated population are not reported in the registry record.
The registry does not provide the statistical analysis plan, sample-size justification, interim-analysis details, missing-data methods or multiplicity procedures. Follow-up completeness and further details of censoring are also not reported. These omissions prevent assessment of the planned inferential framework and of how uncertainty or multiple outcomes may have been handled.
Safety information includes serious-event counts, other adverse-event counts, deaths and selected serious-event terms. However, the registry does not provide results for the named secondary outcomes of grade 3 or above study-drug-related adverse events and immune-related adverse events. The available safety entries should therefore be read as limited descriptive information, not as a complete account of those outcomes or a comparative safety analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma — NCT04209686.
- Registry record last updated 2026-09-01; status last verified 2026-08.
- Results first posted 2026-09-01.
- 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
NCT04209686 is a completed Phase 2, non-randomized, open-label, parallel study sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. It enrolled 19 participants with previously treated advanced gastric adenocarcinoma and evaluated paclitaxel, pembrolizumab and olaparib. The arms were defined by measurable and unmeasurable disease.
Overall survival was the primary outcome, defined from first dose to death or end of follow-up, with Kaplan-Meier estimation and a stated timeframe of up to 27 months. Only participants receiving at least one dose of all three study drugs were evaluable; the record says 15/18 in Arm 1 received the combination. Secondary outcomes concerned grade 3 or above study-drug-related adverse events and immune-related adverse events.
The registry reports 0 analyses and does not report an overall-survival estimate, confidence interval, hazard ratio or results for the named secondary outcomes. Its adverse-event information includes group counts and selected serious-event terms, but the non-randomized disease-measurability arms are not a control comparison.