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 BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NCT03496662), a non-randomized phase 1, phase 2 study. The primary outcome is (Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03496662 |
| Phase | Phase 1, Phase 2 |
| Condition | Pancreatic Ductal Adenocarcinoma |
| Allocation | Non-Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Washington University School of Medicine |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with pancreatic ductal adenocarcinoma described in the title as borderline resectable or locally advanced. The primary safety outcome applies only to participants enrolled in Part A at Experimental Dose Level 0. The registry record lists enrollment of 40, with separate groups for that Part A dose level, a chemotherapy-only control, and Part B dose expansion.
Intervention
The experimental combination includes BMS-813160, nivolumab, gemcitabine and nab-paclitaxel. The record also lists biopsy and peripheral blood procedures. The study description says investigators assessed side effects and disease response. The detailed arm descriptions in the registry record are incomplete, so they do not establish every treatment or procedure detail for each group.
Comparator
Part A includes a chemotherapy-only control group, while the other listed groups receive the experimental combination. Allocation is non-randomized and the study model is sequential. Consequently, the control group is not a randomized, like-for-like comparator; differences between groups cannot be interpreted as an unbiased treatment effect without addressing potential differences in who entered each group and when.
Primary question
The primary outcome asks about the frequency, type and severity of adverse events among participants in Part A Experimental Dose Level 0. It is a safety question, not a primary test of tumor response or survival. Resectability after treatment, progression-free survival and overall survival are listed as secondary outcomes for Part B and Part A Experimental Dose Level 0, but numerical results and statistical analyses for those outcomes are not reported in the registry record.
3. Trial Design
NCT03496662 is a Phase I/II study sponsored by Washington University School of Medicine. The registry record marks it completed and gives enrollment of 40. Its listed dates are 2018-08-31 for study start and 2021-10-28 for primary completion. The study is described as non-randomized, unmasked and sequential. These design features matter when interpreting comparisons: without random allocation, participant characteristics and other factors may differ across groups, and an unmasked design does not provide blinding to treatment assignment.
The record describes three groups: Part A Experimental Dose Level 0, Part A Control (Chemotherapy Only), and Part B Dose Expansion. The experimental groups are associated with BMS-813160, nivolumab, gemcitabine and nab-paclitaxel; the control group is described as receiving chemotherapy only. The arm descriptions are truncated in the registry record, so the complete treatment schedules and all group-specific procedures are not reported in the registry record.
The primary safety outcome is restricted to Part A Experimental Dose Level 0. The registry record identifies the chemotherapy-only group and dose-expansion group separately, but the primary outcome is not defined as a direct comparison across all three groups. Secondary outcomes are listed for Part B and Part A Experimental Dose Level 0: whether disease becomes resectable after treatment, progression-free survival and overall survival. The registry record lists five outcome measures, but no analyses are listed.
The stated study purpose includes learning about side effects and how disease responds to the combination. That purpose does not by itself establish an efficacy result. The registry record does not report a randomized allocation process, a masking procedure, or a statistical plan for comparing groups. It also does not report a protocol-based sample-size justification or interim analyses.
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 | Part A - Experimental Dose Level 0 | Part A - Control (Chemotherapy Only) | Part B - Dose Expansion |
|---|---|---|---|
| STARTED | 7 | 8 | 25 |
| COMPLETED | 6 | 8 | 16 |
| NOT COMPLETED | 1 | 0 | 9 |
Reasons for not completing this period:
| Reason | Part A - Experimental Dose Level 0 | Part A - Control (Chemotherapy Only) | Part B - Dose Expansion |
|---|---|---|---|
| Adverse Event | 0 | 0 | 4 |
| Withdrawal by Subject | 1 | 0 | 2 |
| Death | 0 | 0 | 2 |
| Noncompliance | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: -Only participants enrolled in Part A- Experimental Dose Level 0 are evaluable for this outcome measure.
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 | Part A - Experimental Dose Level 0 | Part A - Control (Chemotherapy Only) | Part B - Dose Expansion | Total |
|---|---|---|---|---|---|
| Participants analysed | 7 | 8 | 25 | 40 | |
| Age, Continuous | years | 71.5 (64 to 78) | 72 (60 to 74) | 68 (48 to 81) | 70 (48 to 81) |
| Sex: Female, Male: Female | Participants | 6 | 4 | 8 | 18 |
| Sex: Female, Male: Male | Participants | 1 | 4 | 17 | 22 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 | 8 | 25 | 40 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 2 | 2 | 5 |
| Race (NIH/OMB): White | Participants | 6 | 5 | 23 | 34 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 7 | 8 | 25 | 40 |
6. Primary Endpoint
The registry lists the primary outcome as (Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events, measured over Through 100 days after completion of treatment (approximately 7.5 months).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the frequency, type and severity of adverse events in participants enrolled in Part A Experimental Dose Level 0. The unit is participants, and the outcome is expressed as a count of participants. The assessment period runs through 100 days after completion of treatment, described as approximately 7.5 months. The registry record states that toxicity reporting uses the revised NCI Common Terminology Criteria for Adverse Events, version 5.0.
This kind of endpoint is used to characterize the safety experience observed during and after treatment. Frequency indicates how many participants had an event; type distinguishes the kinds of events; severity classifies their intensity under the stated grading system. Those dimensions are complementary: a count alone does not describe the event itself or how serious it was.
The endpoint is limited to the specified Part A dose-level group. It should not be treated as the primary result for every participant in the study, nor as a measure of tumor benefit. The registry record does not report a prespecified statistical comparison, an uncertainty interval, or a complete breakdown of adverse-event grades for this endpoint. The posted counts therefore describe recorded events, but they do not establish comparative safety or explain how risk varies over time.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a completed, non-randomized Phase I/II study, but the posted results available for interpretation are limited. It reports participant counts for serious adverse events, other adverse events and deaths across the three listed groups. It does not report statistical analyses: the record lists zero analyses. Nor does it provide numerical findings for the secondary outcomes of resectability, progression-free survival or overall survival. Thus, the listed outcomes identify questions the study addressed, but do not give an efficacy estimate that can be interpreted from this record.
For the primary safety outcome, the record says that only Part A Experimental Dose Level 0 participants are evaluable. The adverse-event summary separately lists 7 participants at risk for serious adverse events and 4 affected; for other adverse events it lists 7 at risk and 7 affected. These are descriptive counts. The registry record does not provide a comparative test or confidence interval for them. The adverse-event summary also lists counts for the chemotherapy-only and dose-expansion groups, but those groups are not randomized counterparts of the primary safety population.
The non-randomized sequential design limits causal interpretation of differences between groups. A difference in observed counts could reflect treatment, differences in group membership, or other factors; the record does not report an adjustment strategy that would separate these explanations. The chemotherapy-only group should not be read as if it were a randomized control arm. Sequential enrollment also means that group membership may be linked to study stage, though the record does not give enough information to describe how that occurred or what participant characteristics differed.
Serious adverse event counts are not interchangeable with all adverse events, and neither count alone conveys event duration, recurrence, severity distribution or timing. The record gives selected serious-event terms and percentages, but the denominator basis for those term percentages is not reported in the registry record. Death counts appear in the same group summary, but their relationship to treatment, cause and timing is not stated there. They should not be interpreted as treatment-attributable deaths.
For efficacy, the record lists the percentage whose disease becomes resectable, progression-free survival and overall survival as secondary outcomes in specified groups. No estimates, event-time summaries, confidence intervals or tests for these outcomes are reported in the registry record. Consequently, the statistical precision and direction of any efficacy findings cannot be assessed from the posted information. The study's completion status does not substitute for outcome estimates, and the registry's stated purpose does not establish the direction or size of a result.
9. Statistical Methods Explained
Statistical interpretation starts by matching each result to its outcome definition and analysis population. In this study, the primary endpoint is a participant count for adverse events in Part A Experimental Dose Level 0, assessed through 100 days after treatment completion. The registry record specifies CTCAE version 5.0 for toxicity reporting. It lists three group summaries, but the primary endpoint's population is narrower than the full study enrollment. An endpoint-specific population matters because a result only describes the participants included in that endpoint, not automatically everyone enrolled.
What does a count describe?
A count reports how many participants experienced an event in the stated group. It is descriptive: by itself it does not show the probability of an event in a wider population, account for follow-up duration, or quantify uncertainty. A proportion can be informative when its numerator and denominator are clearly defined, but comparing proportions does not correct for differences in participant characteristics or study conduct. No new proportions or comparisons should be inferred from the posted counts without an explicit analysis.
The summary distinguishes participants at risk from participants affected. For serious adverse events, it lists 7 at risk and 4 affected in Part A Experimental Dose Level 0, 8 at risk and 5 affected in Part A Control (Chemotherapy Only), and 25 at risk and 17 affected in Part B Dose Expansion. For other adverse events, it lists 7 at risk and 7 affected, 8 at risk and 8 affected, and 25 at risk and 25 affected, respectively. These are recorded group counts. The registry record does not give a method for testing differences between them or adjusting such differences for confounding.
Why does allocation matter?
In a randomized study, chance allocation is intended to make treatment groups comparable on average, supporting a causal interpretation of a between-group contrast. Here, allocation is non-randomized. The record itself cautions that the arms are not a like-for-like control comparison. Participant selection, clinical status, study stage and other factors could differ across groups. A raw contrast therefore cannot be attributed to treatment alone. Statistical adjustment can sometimes address measured differences, but it cannot guarantee removal of bias, and an adjustment plan or adjusted results are not reported in the registry record.
The model is described as sequential. In general, sequential studies can assess interventions or cohorts in stages, but the precise operational details and rules for moving between stages are not reported in the registry record. It would be inappropriate to infer dose-escalation rules, stopping boundaries or decision criteria from the study label alone.
What does statistical precision mean?
In general, a confidence interval gives a range of values compatible with the data under a specified statistical model and procedure. Narrower intervals indicate greater precision under those assumptions; wider intervals indicate less precision. A confidence interval is not a guarantee that the true value lies within the particular interval, and it does not eliminate bias from a non-randomized comparison. The registry record reports no confidence intervals for the outcomes, so their statistical precision cannot be assessed from the posted results.
A p-value, in general, measures how incompatible the observed data are with a specified null model, under the assumptions used for the test. It is not the probability that a treatment has no effect, and it does not measure the size or clinical importance of an effect. The record lists no analyses and reports no p-values. No significance claim can be drawn from the event counts alone.
How should event-time outcomes be read?
Progression-free survival and overall survival are time-to-event outcomes. In general, such outcomes use both the timing of events and the time participants remain under observation. Censoring occurs when an event has not been observed by the end of a participant's available follow-up, or when follow-up ends for another reason. Appropriate analysis accounts for this incomplete event-time information. The registry record names these outcomes but does not report event counts, follow-up summaries, survival estimates, hazard ratios, confidence intervals or analysis methods. Their results and precision therefore cannot be reconstructed from the record.
Resectability after treatment is listed as a secondary outcome for Part B and Part A Experimental Dose Level 0. In general, a binary outcome records whether a defined event or state was observed. Interpretation depends on the exact assessment rule, analysis population, timing and handling of participants whose status is unknown. The registry record does not report numerical results or the detailed analysis rules for this outcome.
What is over-dispersion?
In general, over-dispersion occurs when observed variation in counts is greater than a statistical model expects. It can make standard errors too small if the model assumes less variability than the data contain. This issue can arise in some count-data settings, but the registry record does not report a model for adverse-event counts or enough information to determine whether over-dispersion was assessed. It should be treated as a general methodological consideration, not as a reported feature of this study's analysis.
The record describes a planning illustration based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation and a normal approximation; it says time-to-event illustrations use total events and other illustrations use participants per arm. Those are planning assumptions, not evidence that the study used that design or achieved a particular power. Numerical illustration results are not reported in the registry record, and the trial's own sample-size justification is not reported in the registry record. Such planning calculations are not observed power and do not replace reported outcome estimates with uncertainty intervals.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists several outcomes: the primary safety outcome, the percentage of patients whose disease becomes resectable, progression-free survival and overall survival, among the five outcome measures recorded. It does not report a multiplicity strategy. When several outcomes or comparisons are tested, the chance of at least one false-positive finding can increase if each is assessed separately at the same threshold. General approaches include prespecifying a hierarchy, adjusting significance thresholds, or treating analyses as exploratory. The record does not state which, if any, approach was used, and no analyses are listed.
Missing-data methods are not reported in the registry record. This matters because a participant may lack an endpoint assessment, have incomplete follow-up, or have an event status that cannot be determined. The available counts do not explain how missing or unevaluable observations were handled, whether follow-up differed across groups, or whether sensitivity analyses were conducted. The primary outcome description identifies Part A Experimental Dose Level 0 as the evaluable population, but does not explain exclusions or missing outcome assessments.
Analysis populations for the secondary outcomes are specified as Part B and Part A Experimental Dose Level 0. The record does not give further analysis-population definitions, such as how participants who discontinued treatment or did not complete an assessment were handled. It also does not report whether analyses were adjusted, which covariates might have been considered, or how censoring was handled for time-to-event outcomes. These omissions limit reproducibility and make it difficult to judge how robust any potential result would be. The registry record does not report an interim-analysis plan or stopping rules.
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 |
|---|---|---|---|
| Part A - Experimental Dose Level 0 | 4 | 7 | 57.1% |
| Part A - Control (Chemotherapy Only) | 5 | 8 | 62.5% |
| Part B - Dose Expansion | 17 | 25 | 68.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Part A - Experimental Dose Level 0 | 5 of 7 |
| Part A - Control (Chemotherapy Only) | 4 of 8 |
| Part B - Dose Expansion | 21 of 25 |
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 |
|---|---|
| Part A - Experimental Dose Level 0 | 7 of 7 |
| Part A - Control (Chemotherapy Only) | 8 of 8 |
| Part B - Dose Expansion | 25 of 25 |
Most frequent serious adverse event terms
| Event term | Organ system | Part A - Experimental Dose Level 0 | Part A - Control (Chemotherapy Only) | Part B - Dose Expansion |
|---|---|---|---|---|
| Sepsis | Infections and infestations | 0 of 7 | 2 of 8 | 2 of 25 |
| Fever | General disorders | 1 of 7 | 1 of 8 | 1 of 25 |
| Pancreatitis | Gastrointestinal disorders | 0 of 7 | 0 of 8 | 2 of 25 |
| Vomiting | Gastrointestinal disorders | 0 of 7 | 0 of 8 | 2 of 25 |
| Cholecystitis | Hepatobiliary disorders | 1 of 7 | 0 of 8 | 1 of 25 |
| Lung infection | Infections and infestations | 0 of 7 | 0 of 8 | 2 of 25 |
| Hypokalemia | Metabolism and nutrition disorders | 0 of 7 | 0 of 8 | 2 of 25 |
| Hyponatremia | Metabolism and nutrition disorders | 0 of 7 | 0 of 8 | 2 of 25 |
| Hypotension | Vascular disorders | 0 of 7 | 1 of 8 | 1 of 25 |
| Febrile neutropenia | Blood and lymphatic system disorders | 0 of 7 | 0 of 8 | 1 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part A - Experimental Dose Level 0 | Part A - Control (Chemotherapy Only) | Part B - Dose Expansion |
|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 7 of 7 | 4 of 8 | 25 of 25 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 5 of 7 | 3 of 8 | 23 of 25 |
| Fatigue | General disorders | 6 of 7 | 3 of 8 | 20 of 25 |
| Alopecia | Skin and subcutaneous tissue disorders | 7 of 7 | 4 of 8 | 18 of 25 |
| Platelet count decreased | Investigations | 7 of 7 | 3 of 8 | 18 of 25 |
| Alanine aminotransferase increased | Investigations | 6 of 7 | 4 of 8 | 17 of 25 |
| White blood cell decreased | Investigations | 6 of 7 | 4 of 8 | 17 of 25 |
| Aspartate aminotransferase increased | Investigations | 6 of 7 | 4 of 8 | 14 of 25 |
| Nausea | Gastrointestinal disorders | 6 of 7 | 1 of 8 | 15 of 25 |
| Diarrhea | Gastrointestinal disorders | 3 of 7 | 4 of 8 | 14 of 25 |
Serious events with the highest arm-level rate: sepsis (25.0%), upper gastrointestinal hemorrhage (14.3%), fever (14.3%), cholecystitis (14.3%), gallbladder obstruction (14.3%).
The adverse-event summary reports participants at risk and participants affected in each group. For serious adverse events, the counts are 4 of 7 in Part A Experimental Dose Level 0, 5 of 8 in Part A Control (Chemotherapy Only), and 17 of 25 in Part B Dose Expansion. For other adverse events, the counts are 7 of 7, 8 of 8 and 25 of 25, respectively. These are descriptive group summaries; they do not provide a randomized comparison or an estimate adjusted for differences between groups.
The record lists sepsis at 25.0%, and upper gastrointestinal hemorrhage, fever, cholecystitis, gallbladder obstruction and hypoglycemia at 14.3% each among the top serious-event terms. The denominator basis for these term percentages is not reported in the registry record. A term percentage should therefore not be treated as a rate among all enrolled participants unless its denominator is established.
Death counts are 5 in Part A Experimental Dose Level 0, 4 in Part A Control (Chemotherapy Only), and 21 in Part B Dose Expansion. The registry record does not report cause, timing or attribution for these deaths. They cannot be interpreted as deaths caused by treatment. Counts also do not describe event duration, recurrence or severity grades; those details are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The posted results support a limited descriptive account of adverse events in the three listed groups. They show how many participants were recorded as affected by serious and other adverse events, and the registry lists selected serious-event terms. The primary safety endpoint is defined for Part A Experimental Dose Level 0, rather than for the study population as a whole. These observations describe what was recorded in the stated groups; they do not, by themselves, establish that the combination caused an event or that one group had greater risk than another.
The design is non-randomized and sequential, and the record explicitly warns that the arms are not a like-for-like control comparison. Differences in counts across groups can reflect differences in who entered each group or other factors as well as treatment. No comparative statistical analysis or uncertainty interval is reported. The record therefore does not support a precise estimate of a treatment effect or a causal conclusion about safety.
The registry lists resectability, progression-free survival and overall survival as secondary outcomes, but does not report their numerical results or analyses. It is not possible to state from this record whether these outcomes improved, worsened or remained unchanged, or how precisely they were estimated. The study's completed status and its stated research purpose do not fill that evidentiary gap.
In general, a single-arm or non-randomized study can provide useful descriptive information and help identify questions for further evaluation, while remaining limited for causal comparisons. That general point does not establish what this study found beyond the posted counts. The registry record also does not report full analysis methods, handling of missing data, or a multiplicity strategy, further limiting assessment of reliability and completeness.
13. Why This Trial Matters Statistically
This study is statistically notable because the registry records both an experimental combination and a chemotherapy-only group, but allocation is non-randomized and the model is sequential. That combination of features makes it essential to distinguish a descriptive group summary from a causal comparison. A group difference is not automatically evidence that treatment produced the difference when allocation does not create comparable groups by design.
The primary endpoint is safety-focused and applies only to Part A Experimental Dose Level 0. This defined population helps clarify what the endpoint was intended to describe, while also limiting how broadly its results can be applied. The other group counts add context about the enrolled study arms, but they do not turn the primary safety endpoint into a randomized comparison.
The record also illustrates why outcome listings and outcome results are different. Resectability, progression-free survival and overall survival are named, but numerical analyses are absent. Without estimates and measures of uncertainty, readers cannot assess the size or precision of any association. The registry record's zero listed analyses is especially relevant: the posted counts should not be mistaken for a complete statistical report.
Finally, the record's safety detail includes serious-event terms and death counts, but does not report the denominator basis for term percentages or the timing and causes of deaths. These distinctions are important when interpreting adverse-event summaries. Overall, the study's statistical value in this registry record lies in its design description and descriptive safety information, alongside clear limits on comparative and efficacy interpretation.
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.
Several limitations are specific to interpreting this record. First, the design is non-randomized and sequential, and the registry cautions that the arms are not a like-for-like control comparison. Unadjusted differences across the experimental, chemotherapy-only and dose-expansion groups cannot isolate a treatment effect. The registry record does not report an adjustment plan or adjusted comparisons.
Second, the primary safety endpoint applies only to Part A Experimental Dose Level 0. The study enrollment is 40, but the group-specific at-risk counts are 7, 8 and 25. The registry record does not explain the relationship between enrollment and endpoint evaluability or provide a detailed accounting of missing observations. The primary endpoint's specified population should not be conflated with all study participants.
Third, the record lists secondary efficacy outcomes without numerical results or analyses. It also gives no confidence intervals, p-values, survival estimates or detailed event-time methods. The record's top serious-event term percentages lack a reported denominator basis, while death counts lack reported cause, timing and attribution. These gaps restrict both precision and interpretation.
Fourth, the complete arm schedules are not available in the registry record because the descriptions are truncated. The record does not report the statistical plan, interim analyses, missing-data methods, multiplicity strategy, or protocol-based sample-size justification. The planning illustration is not the trial's own design and is not an observed-power analysis. These limitations prevent a full assessment of reproducibility and analysis choices.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) — NCT03496662.
- Registry record last updated 2025-07-29; status last verified 2025-07.
- Results first posted 2022-11-30.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03496662 is a completed, non-randomized Phase I/II study of BMS-813160 with nivolumab, gemcitabine and nab-paclitaxel for pancreatic ductal adenocarcinoma described as borderline resectable or locally advanced. The registry record lists enrollment of 40 and three groups: Part A Experimental Dose Level 0, Part A Control (Chemotherapy Only), and Part B Dose Expansion.
The primary outcome is a count-based assessment of adverse-event frequency, type and severity among Part A Experimental Dose Level 0 participants, through 100 days after treatment completion. The record reports serious and other adverse-event counts and selected serious-event terms. It lists resectability, progression-free survival and overall survival as secondary outcomes but does not report numerical results or analyses for them. The registry record lists zero analyses and does not report a statistical analysis plan, missing-data methods or multiplicity strategy. Because allocation is non-randomized, the groups are not like-for-like controls for causal comparison.