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 A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia (NCT02011945), a non-randomized phase 1 study. The primary outcome is Incidence of Dose Limiting Toxicities (DLT).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02011945 |
| Phase | Phase 1 |
| Condition | Chronic Myeloid Leukemia |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bristol-Myers Squibb |
| Results posted | Yes |
2. Clinical Question
Population
Participants with chronic myeloid leukemia were eligible for this study. The registry record gives an enrollment figure of 35 and identifies the primary endpoint population as all treated participants. It also distinguishes chronic-phase participants with and without prior dasatinib exposure, and advanced-phase participants, in listed secondary outcomes.
Intervention
The study investigated nivolumab added to dasatinib. Dose Level 1 paired nivolumab 1 mg/kg every 2 weeks with dasatinib 100 mg once daily for CP or 140 mg once daily for AP. Dose Level 2 paired nivolumab 3 mg/kg every 2 weeks with the same phase-specific dasatinib doses.
Comparator
An arm labelled dasatinib Only is described as dasatinib 100 mg once daily for CP or 140 mg once daily for AP. The registry classifies allocation as non-randomized, so the arm descriptions do not constitute a randomized, like-for-like control comparison. The record does not explain how participants entered each arm.
Primary question
The primary endpoint is the number of incidences of dose-limiting toxicities (DLTs) during the specified early treatment period among all treated participants. DLTs are defined using the incidence and intensity of drug-related adverse events. The registry record does not report the observed primary endpoint result.
The study title describes an investigation of safety and preliminary efficacy for dasatinib plus nivolumab in chronic myeloid leukemia. Its brief summary frames the purpose as finding a nivolumab dose that can be safely added to dasatinib. The listed dose levels allow the study to examine two nivolumab doses alongside phase-specific dasatinib dosing, while a dasatinib-only arm is also described.
This is a dose-escalation study, not a randomized comparison. The registry lists a single-group model and non-randomized allocation, and explicitly cautions that the arms are not a like-for-like control comparison. Therefore, arm-level differences cannot be read as unbiased treatment effects. Participant characteristics, disease phase, prior dasatinib exposure, and the way participants were assigned to arms could all affect comparisons, but the assignment process and arm comparability are not reported in the registry record.
The primary question is about the occurrence of protocol-defined DLTs, rather than whether one regimen improves an outcome relative to another. Secondary outcomes include molecular response measures and time to major molecular response for specified CML subgroups. The record lists those outcomes but gives no analysis results for them. As a result, the registry information describes what the study set out to examine, but does not establish the observed response or toxicity results.
3. Trial Design
The registry identifies NCT02011945 as a Phase 1B study sponsored by Bristol-Myers Squibb. It records the study as completed, with a start date of 2014-02-07 and a primary completion date of 2018-12-26. The enrollment figure is 35. The condition is chronic myeloid leukemia, and the listed interventions are dasatinib and nivolumab.
The registry design fields classify the study as non-randomized, unmasked, and single-group. These classifications matter when interpreting the arm descriptions: a dasatinib-only group and two combination dose levels are described, but allocation was not randomized. The record explicitly warns that the arms are not a like-for-like control comparison. It does not state how participants were allocated, whether all participants received the same treatment sequence, or whether the arm descriptions represent the complete protocol structure.
The dasatinib-only arm description specifies 100 mg once daily for CP and 140 mg once daily for AP. Dose Level 1 adds nivolumab 1 mg/kg every 2 weeks, and Dose Level 2 adds nivolumab 3 mg/kg every 2 weeks; both retain the phase-specific dasatinib doses. The record does not define the abbreviations CP and AP beyond using them in the arm descriptions and outcome labels.
The primary endpoint is incidence of dose-limiting toxicities, measured as a number, with all treated participants identified as the population. Its registry timeframe is labelled “Week 3 to week 6,” while the endpoint description defines DLTs occurring during the first 6 weeks of combined treatment and calls that period “Weeks 3 to 8, inclusive.” These time descriptions do not align exactly; the registry record does not clarify the difference.
Although multiple secondary outcomes are listed, the registry reports 0 analyses. Outcome results, analysis populations beyond the stated primary population, treatment assignment procedures, and follow-up details are not reported in the registry record. The completed status therefore indicates the status recorded for the study, not that the posted record contains results for every endpoint.
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: 35 Participants enrolled; 31 participants randomized. Reasons not randomized: 1 participant withdrew consent, 3 participants no longer met the study criteria.
Overall Study
| Stage | Dasatinib Only | Dose Level 1 | Dose Level 2 |
|---|---|---|---|
| STARTED | 2 | 13 | 16 |
| COMPLETED | 0 | 3 | 6 |
| NOT COMPLETED | 2 | 10 | 10 |
Reasons for not completing this period:
| Reason | Dasatinib Only | Dose Level 1 | Dose Level 2 |
|---|---|---|---|
| Participant requested to Discontinue | 0 | 1 | 1 |
| Adverse Event unrelated to Drug | 0 | 2 | 1 |
| Study Drug Toxicity | 0 | 0 | 1 |
| Treatment Failure | 0 | 7 | 6 |
| No Longer Meets Study Criteria | 1 | 0 | 0 |
| Proceeded to stem cell transplant | 0 | 0 | 1 |
| Sub-Optimal Response to dasatinib | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All Treated 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.
| Characteristic | Unit | Dasatinib Only | Dose Level 1 | Dose Level 2 | Total |
|---|---|---|---|---|---|
| Participants analysed | 2 | 13 | 16 | 31 | |
| Age, Continuous | Years | 48.5 (SD 13.4) | 61.2 (SD 12.4) | 47.1 (SD 13.6) | 53.1 (SD 14.5) |
| Sex: Female, Male: Female | Participants | 1 | 7 | 5 | 13 |
| Sex: Female, Male: Male | Participants | 1 | 6 | 11 | 18 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 4 | 8 | 12 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 9 | 7 | 18 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 2 | 2 | 4 |
| Race (NIH/OMB): White | Participants | 2 | 11 | 13 | 26 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Incidence of Dose Limiting Toxicities (DLT), measured over Week 3 to week 6.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Number of Incidence |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the incidence of dose-limiting toxicities, expressed as a number, among all treated participants. A DLT is defined by drug-related adverse-event incidence and intensity during the early period of combined dasatinib and nivolumab treatment. The listed criteria cover serious or persistent hematologic and nonhematologic toxicity, toxicity leading to nivolumab discontinuation, and certain toxicities requiring interruption of dasatinib or missed nivolumab doses. The record specifies that the event may be related to either or both agents.
In general, a DLT endpoint is used in dose-escalation research to describe whether treatment-related toxicities meet prespecified thresholds during a defined observation period. It focuses on events considered important for dose evaluation, rather than counting every adverse event as a DLT. The detailed criteria are therefore central to interpretation: an event contributes only if it meets the stated grade, duration, intervention, or treatment-management conditions.
The registry labels the timeframe “Week 3 to week 6,” but the explanatory definition refers to the first 6 weeks of combined treatment as “Weeks 3 to 8, inclusive.” Those descriptions differ, and the record does not resolve the discrepancy. The posted results do not state how many DLTs occurred, so the endpoint’s observed value and its precision cannot be assessed from the registry record. The endpoint definition is available, but its result is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record is informative about the study question and planned endpoint, but it does not include the primary endpoint result. The main endpoint is a count of protocol-defined DLTs among all treated participants. Without the observed count or an uncertainty interval, it is not possible to describe the frequency of DLTs in the study population or how precisely that frequency was estimated. The study’s completed status does not substitute for an endpoint result.
The record describes three arm labels: dasatinib Only, Dose Level 1, and Dose Level 2. Safety records list 2 participants at risk in the dasatinib-only group, 13 in Dose Level 1, and 16 in Dose Level 2. These are arm-specific counts in the adverse-event information, not evidence of randomized assignment. The registry explicitly identifies the study as non-randomized and cautions that arms are not comparable as like-for-like controls. Any apparent contrast among arm counts would be descriptive and could reflect differences in who entered each group, as well as differences in treatment.
Serious adverse events were reported for 0 of 2 in the dasatinib-only group, 7 of 13 in Dose Level 1, and 8 of 16 in Dose Level 2. Other adverse events were reported for 1 of 2, 13 of 13, and 16 of 16, respectively. Deaths were recorded as 0, 2, and 0 for those same groups. These are descriptive safety entries; they are not the primary DLT outcome, and the record does not identify which events met the DLT criteria. It also does not provide event-level timing or establish causation for each event.
The registry lists secondary outcomes involving major molecular response and MR4.5 rates across chronic-phase subgroups defined by prior dasatinib exposure and advanced-phase participants. Time to major molecular response is also listed for chronic-phase participants with and without prior dasatinib. The registry record reports 0 analyses, and no numerical outcome results or uncertainty estimates are included. Thus, these entries describe outcome topics, not demonstrated efficacy findings.
In general, estimates based on small groups can be imprecise, and non-randomized groups may differ in ways that confound comparisons. These limitations are especially relevant when interpreting the safety counts as contrasts across arms. No treatment effect, dose-response relation, or comparative efficacy conclusion can be established from the posted record. The sound statistical reading is to distinguish the study’s stated aims and recorded safety counts from outcome analyses that are not reported.
9. Statistical Methods Explained
The registry identifies this as a Phase 1B dose-escalation study with non-randomized allocation, no masking, and a single-group model. In general, randomization is used to make treatment groups comparable on average with respect to measured and unmeasured participant characteristics. When allocation is not randomized, differences between arms can reflect both treatment and group composition. The registry itself warns that the listed arms are not a like-for-like control comparison. The allocation procedure and any methods used to adjust for baseline differences are not reported in the registry record.
What does the primary endpoint count?
The primary endpoint is a number of DLT incidences, rather than a continuous measurement or time-to-event estimate. The DLT definition is based on drug-related adverse-event severity, persistence, management, or effect on treatment. In general, a count endpoint is interpreted by specifying both what qualifies as an event and the population in which events are counted. Here, the endpoint population is identified as all treated participants. The registry does not report the observed count, a rate, an uncertainty interval, or an inferential test for the primary endpoint.
The timing definition also matters. The registry timeframe says “Week 3 to week 6,” whereas the detailed criteria refer to the first 6 weeks of combined treatment as “Weeks 3 to 8, inclusive.” A time window determines which events can contribute to an endpoint, so the mismatch limits clarity about the exact observation period. No reconciliation is reported in the registry record.
How should the arm descriptions be treated?
The listed treatment descriptions include dasatinib alone and dasatinib with either nivolumab 1 mg/kg or nivolumab 3 mg/kg every 2 weeks. The registry labels the design single-group while also presenting three safety groups. Those descriptions do not establish random assignment or equivalence between groups. In general, a comparison of non-randomized groups is vulnerable to confounding: characteristics associated with group placement may also be associated with outcomes. The record does not report a comparison method, covariate adjustment, or a prespecified statistical model.
Arm-specific safety counts are descriptive. A count of participants with an event does not by itself convey event duration, recurrence, severity distribution, or whether events were judged treatment-related. The serious-event terms listed with percentages do not provide the full event-level context. In general, uncertainty around estimates is important, particularly when group sizes are small; the registry does not report confidence intervals for these safety entries.
What can be inferred from the listed outcomes?
Major molecular response, MR4.5, and time to major molecular response appear among the secondary outcomes. In general, a response rate summarizes the proportion of a defined population meeting a response criterion, while a time-to-event outcome concerns how long it takes for an event to occur and may require information about censoring and follow-up. The registry lists those outcomes by disease phase and prior dasatinib status, but it does not report the corresponding estimates, denominators, event times, censoring information, or statistical analyses. No response result should be inferred from an outcome label alone.
The record reports 24 outcome measures and 0 analyses. It does not describe the statistical plan, whether outcomes were analyzed according to an intention-to-treat or per-protocol principle, how missing outcome data were handled, or whether an interim analysis occurred. In general, analysis populations and missing-data rules can affect the meaning of an estimate; those methods are not reported in the registry record.
How should multiplicity and precision be considered?
When a study examines multiple outcomes or multiple subgroup-specific results, the chance of observing an apparently notable result by chance can increase if many hypotheses are tested. In general, multiplicity methods may control that risk, but the registry does not report whether any such approach was planned or used. The number of listed outcome measures alone does not show how many statistical tests were conducted; the registry lists 0 analyses.
Precision is ordinarily evaluated using an uncertainty interval alongside an estimate. A confidence interval describes the range of values reasonably compatible with the observed data under the specified statistical method. It does not eliminate design limitations or establish causality. No confidence intervals or primary endpoint estimates are reported in the registry record, so precision cannot be evaluated for the primary result.
The record includes sample-size planning assumptions for an illustration based on an observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect, and distinguishes participant-per-arm illustrations from total-event illustrations for time-to-event outcomes. These assumptions describe planning illustrations, not the trial’s own design justification or observed power. The observed effect, calculated planning values, and sample-size justification are not reported in the registry record. The illustration cannot be interpreted as evidence that the trial had a specified probability of detecting an effect.
Overall, the record supplies design classifications, endpoint definitions, treatment descriptions, and selected safety counts, but not a statistical analysis plan or endpoint analyses. General statistical principles can explain why these omissions matter, but they cannot fill in the missing results or methods.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes, including major molecular response rates, MR4.5 rates, and time to major molecular response. Several outcomes are separated by chronic-phase disease and prior dasatinib exposure, with additional advanced-phase outcomes. Examining multiple endpoints and subgroups can raise multiplicity concerns because repeated testing may increase the chance of a chance finding. In general, statistical plans may specify a hierarchy or adjustment to address this issue. Whether such a plan or adjustment was used is not reported in the registry record.
The registry reports 24 outcome measures and 0 analyses. It gives no numerical result for the primary DLT endpoint or the listed secondary outcomes. The analysis population is stated as all treated participants for the primary endpoint, but analysis populations for secondary outcomes are not reported in the registry record. The record also does not describe how missing measurements, withdrawals, or incomplete follow-up were handled. In general, missing-data methods can affect both the estimate and its uncertainty, so the absence of these details restricts interpretation.
There is no reported statistical analysis plan, prespecified testing sequence, interim analysis information, or explanation of whether the secondary outcomes were exploratory or confirmatory. These details are not reported in the registry record. The number of outcomes listed does not establish that all were tested, and the count of analyses reported as zero does not provide evidence about what analyses may have been performed outside the registry entry. Without posted analyses and methods, neither multiplicity control nor the impact of missing data can be evaluated.
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 |
|---|---|---|---|
| Dasatinib Only | 0 | 2 | 0.0% |
| Dose Level 1 | 7 | 13 | 53.8% |
| Dose Level 2 | 8 | 16 | 50.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dasatinib Only | 0 of 2 |
| Dose Level 1 | 2 of 13 |
| Dose Level 2 | 0 of 16 |
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 |
|---|---|
| Dasatinib Only | 1 of 2 |
| Dose Level 1 | 13 of 13 |
| Dose Level 2 | 16 of 16 |
Most frequent serious adverse event terms
| Event term | Organ system | Dasatinib Only | Dose Level 1 | Dose Level 2 |
|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 0 of 2 | 1 of 13 | 1 of 16 |
| Blast crisis in myelogenous leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 2 | 1 of 13 | 1 of 16 |
| Abdominal pain upper | Gastrointestinal disorders | 0 of 2 | 0 of 13 | 1 of 16 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0 of 2 | 1 of 13 | 0 of 16 |
| Nausea | Gastrointestinal disorders | 0 of 2 | 0 of 13 | 1 of 16 |
| Device related thrombosis | General disorders | 0 of 2 | 0 of 13 | 1 of 16 |
| Influenza like illness | General disorders | 0 of 2 | 1 of 13 | 0 of 16 |
| Cholelithiasis | Hepatobiliary disorders | 0 of 2 | 0 of 13 | 1 of 16 |
| Bronchiolitis | Infections and infestations | 0 of 2 | 1 of 13 | 0 of 16 |
| Epiglottitis | Infections and infestations | 0 of 2 | 1 of 13 | 0 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dasatinib Only | Dose Level 1 | Dose Level 2 |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 0 of 2 | 6 of 13 | 7 of 16 |
| Vomiting | Gastrointestinal disorders | 0 of 2 | 4 of 13 | 6 of 16 |
| Nausea | Gastrointestinal disorders | 0 of 2 | 3 of 13 | 6 of 16 |
| Headache | Nervous system disorders | 0 of 2 | 4 of 13 | 5 of 16 |
| Anaemia | Blood and lymphatic system disorders | 0 of 2 | 4 of 13 | 4 of 16 |
| Upper respiratory tract infection | Infections and infestations | 0 of 2 | 5 of 13 | 3 of 16 |
| Cough | Respiratory, thoracic and mediastinal disorders | 0 of 2 | 6 of 13 | 2 of 16 |
| Thrombocytopenia | Blood and lymphatic system disorders | 0 of 2 | 3 of 13 | 4 of 16 |
| Pyrexia | General disorders | 0 of 2 | 5 of 13 | 2 of 16 |
| Rash | Skin and subcutaneous tissue disorders | 0 of 2 | 2 of 13 | 5 of 16 |
Serious events with the highest arm-level rate: febrile neutropenia (7.7%), gastrointestinal haemorrhage (7.7%), influenza like illness (7.7%), bronchiolitis (7.7%), epiglottitis (7.7%).
The adverse-event information gives group-specific numbers at risk, numbers affected by serious and other adverse events, and deaths. For serious adverse events, the record lists 0 of 2 in the dasatinib-only group, 7 of 13 in Dose Level 1, and 8 of 16 in Dose Level 2. For other adverse events, it lists 1 of 2, 13 of 13, and 16 of 16, respectively. Deaths are recorded as 0, 2, and 0. These are counts within the registry’s safety groups, not randomized comparisons.
The serious-event terms listed include febrile neutropenia, gastrointestinal haemorrhage, influenza like illness, bronchiolitis, epiglottitis, and septic shock, each reported as 7.7%. The record does not provide further event-level details alongside these terms, such as timing, recurrence, or participant-level context. These percentages should not be interpreted as comparative risks between treatments or as DLT rates.
In general, serious adverse events and protocol-defined DLTs are distinct summaries. A serious event need not meet the stated DLT criteria, and a DLT definition can include treatment-management rules beyond seriousness. The registry does not identify which recorded serious events met the DLT definition. Because allocation was non-randomized and group sizes are limited, the counts are descriptive; they do not establish that a treatment caused an event or that one dose level is safer than another.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a Phase 1B study investigated dasatinib with nivolumab in chronic myeloid leukemia, with a focus on safety and preliminary efficacy. It specifies two nivolumab dose levels alongside phase-specific dasatinib dosing and identifies incidence of dose-limiting toxicities as the primary endpoint. Those details explain the study’s purpose and the kinds of observations it was designed to collect.
The posted information does not include the primary DLT count or results for the listed molecular response outcomes. It therefore cannot establish how often DLTs occurred, whether the observed frequency was estimated precisely, or what response outcomes were observed. The completed status and the enrollment figure do not answer those questions. No efficacy conclusion can be drawn from the list of secondary outcomes alone.
The adverse-event counts provide a descriptive account by listed safety group, but the design was non-randomized. The registry explicitly cautions that the groups are not a like-for-like control comparison. In general, non-randomized arm differences may be influenced by participant characteristics, disease phase, prior treatment, or other factors. The record does not report sufficient information to adjust for such factors or to establish a causal treatment contrast.
The study should therefore be read as a registry entry that documents a clinical question, treatment descriptions, endpoint definitions, and selected safety summaries, while leaving the central outcome analyses unavailable. The DLT definition and the time-window discrepancy also matter: the registry gives two different descriptions of the assessment period and does not explain how they align.
These limitations do not show that the study had no findings; they mean that those findings are not reported in the registry record. Statistical interpretation must remain bounded by the posted information. No claim about comparative safety, effectiveness, dose choice, or clinical benefit follows from the available entry.
13. Why This Trial Matters Statistically
This trial raises several important statistical issues for readers of early-phase clinical research. Its primary endpoint is a defined toxicity count, and the registry gives detailed criteria for what constitutes a DLT. In general, this kind of endpoint makes the event definition and observation window central to interpretation. Here, the registry labels the timeframe “Week 3 to week 6” but also describes the relevant period as “Weeks 3 to 8, inclusive.” That mismatch illustrates why endpoint timing needs to be unambiguous.
The study also demonstrates the distinction between a dose-escalation question and a comparative treatment question. The record describes a dasatinib-only arm and two combination dose levels, but classifies allocation as non-randomized and cautions that the arms are not like-for-like controls. This is important because differences between groups cannot automatically be attributed to the dose or the addition of nivolumab. General principles of causal inference require attention to group comparability and allocation.
Finally, the registry includes safety counts and a broad set of secondary outcomes but reports 0 analyses. The distinction between endpoint definitions and endpoint results is fundamental: knowing what researchers intended to measure does not reveal the estimate, its uncertainty, or the methods used to analyze it. The record’s omissions also show why reporting an analysis plan, missing-data approach, and multiplicity strategy matters when several outcomes and subgroups are listed. These considerations support careful reading without turning descriptive registry information into an unsupported treatment conclusion.
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 central limitation is that the registry record does not report the primary endpoint result. It describes DLT criteria and a primary population, but gives no DLT count, estimate, confidence interval, or analysis. The listed secondary outcomes likewise have no reported results, despite 24 outcome measures being recorded and 0 analyses.
The endpoint timing is not fully clear: the registry timeframe says “Week 3 to week 6,” while the detailed definition refers to the first 6 weeks of combined treatment as “Weeks 3 to 8, inclusive.” The record does not reconcile these descriptions. This makes it difficult to know precisely which period governs the endpoint based on the registry entry alone.
Design interpretation is limited by non-randomized allocation and the registry’s warning that arms are not like-for-like controls. The assignment process, baseline comparability, and any adjustment methods are not reported in the registry record. The structured design classification also says single-group while arm-specific descriptions and safety groups are listed; further explanation of that structure is not reported.
Additional limitations include the absence of a statistical analysis plan, missing-data methods, analysis populations for secondary outcomes, and information on interim analyses or multiplicity handling. The safety entries are descriptive and do not identify which adverse events met DLT criteria. The record does not provide enough context to infer causation, compare groups fairly, or evaluate the precision of outcome estimates. These are limitations of the registry information available, not proof that the study did not collect or analyze further information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia — NCT02011945.
- Registry record last updated 2020-03-18; status last verified 2020-02.
- Results first posted 2019-01-17.
- 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
NCT02011945 is recorded as a completed Phase 1B study sponsored by Bristol-Myers Squibb, with chronic myeloid leukemia as the condition and an enrollment figure of 35. The registry lists dasatinib alone and two nivolumab-plus-dasatinib dose levels. Allocation is classified as non-randomized, masking as none, and the model as single-group.
The primary endpoint is incidence of dose-limiting toxicities among all treated participants. Secondary outcomes include major molecular response, MR4.5, and time to major molecular response for specified disease-phase and prior-dasatinib groups. Safety counts and serious adverse-event terms are recorded by group.
The registry lists 24 outcome measures and 0 analyses. It does not report the primary endpoint result, secondary outcome results, or a statistical analysis plan. The arm comparisons are not randomized, and the record warns that they are not like-for-like controls. Interpretation is therefore limited to the design descriptions, endpoint definitions, and descriptive safety information recorded.