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 Nab-Paclitaxel and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery (NCT02158520), a randomized phase 2 study. The primary outcome is Progression-free Survival (PFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02158520 |
| Phase | Phase 2 |
| Condition | Metastatic Melanoma, Mucosal Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7 |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 24 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Academic and Community Cancer Research United |
| Results posted | Yes |
2. Clinical Question
Population
People with stage IV melanoma that could not be removed by surgery were eligible. The registry lists metastatic, mucosal, cutaneous stage IV, and uveal stage IV melanoma among the conditions. The total enrollment was 24.
Intervention
One randomized group received nab-paclitaxel and bevacizumab. The registry describes intravenous dosing on specified treatment days, with courses repeating while disease had not progressed and toxicity remained acceptable.
Comparator
The other group received ipilimumab intravenously, with treatment scheduled for up to 4 courses if there was no disease progression or unacceptable toxicity. The registry describes the study as unmasked.
Primary question
The primary endpoint was progression-free survival, measured from randomization until disease progression under RECIST version 1.1 or death from any cause, whichever came first. The registry reports arm-specific medians and confidence-interval bounds, but not a reported comparative hazard ratio or other formal between-arm estimate.
The clinical question was whether the two treatment strategies differed in the time participants remained alive without documented progression. It was addressed in a randomized phase II study, rather than a study designed in the registry record as a definitive confirmatory comparison. The treatment descriptions also allowed crossover after progression, so participants could move from their initial group to the other treatment. The registry does not report how many participants actually crossed over or when they did so.
3. Trial Design
This was a randomized phase II trial comparing nab-paclitaxel plus bevacizumab with ipilimumab as first-line therapy for unresectable stage IV melanoma. The registry records 24 participants enrolled and lists 12 participants in each initial treatment group. The study was unmasked, meaning treatment assignment was not concealed from participants and study personnel through masking. The design is recorded as crossover.
The treatment schedules differed. Arm A received bevacizumab on days 1 and 15 and nab-paclitaxel on days 1, 8, and 15, with courses repeating every 28 days while disease had not progressed and toxicity was acceptable. Arm B received ipilimumab on day 1, with treatment repeated every 21 days for up to 4 courses under similar progression and toxicity conditions. The registry states that participants experiencing progression could cross over to the other treatment. It does not report how many did so, the timing of crossover, or how crossover was handled in the primary analysis.
The registry lists a study start date of 2013-10-18, primary completion on 2017-05-24, and status as completed. It identifies Academic and Community Cancer Research United as the sponsor. These administrative details do not establish how participants were selected, the exact allocation procedure, or the analysis population. Those details are not reported in the registry record. Nor is a sample-size justification or a detailed statistical analysis plan reported. The modest enrollment makes the posted results useful as a description of this trial, while limiting how much precision can be expected from comparisons between groups.
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 | Arm A (Bevacizumab and Nab-paclitaxel) | Arm B (Ipilimumab) |
|---|---|---|
| STARTED | 12 | 12 |
| AE Evaluated Prior to Crossover | 12 | 12 |
| Eligible for Crossover | 8 | 8 |
| Eligible for Crossover With AE Evaluated | 7 | 7 |
| Crossover Cohort | 4 | 6 |
| COMPLETED | 12 | 12 |
| NOT COMPLETED | 0 | 0 |
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 | Arm A (Bevacizumab and Nab-paclitaxel) | Arm B (Ipilimumab) | Total |
|---|---|---|---|---|
| Participants analysed | 12 | 12 | 24 | |
| Age, Continuous | years | 60 (37 to 77) | 61 (38 to 81) | 61 (37 to 81) |
| Sex/Gender, Customized: Sex/Gender – Male | Participants | 8 | 7 | 15 |
| Sex/Gender, Customized: Sex/Gender – Female | Participants | 4 | 4 | 8 |
| Sex/Gender, Customized: Sex/Gender – Unknown | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 12 | 12 | 24 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Prior radiation therapy | Participants | 4 | 3 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival (PFS), measured over From randomization to the earliest documentation of progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) or death from any cause without the documentation of progression, assessed up to 4 years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | days |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival is a time-to-event endpoint. For each participant, the recorded time begins at randomization and ends at the earliest of documented disease progression or death from any cause. The registry defines progression using RECIST version 1.1: progression can involve an increase in the sum of target-lesion diameters, measurable worsening of a non-target lesion, or the appearance of new lesions. The registry gives the study timeframe as assessment up to 4 years.
The median progression-free survival is the time by which half of the participants in the relevant group have experienced the event, as estimated from the observed follow-up. It offers a compact description of the distribution of time to progression or death. It does not describe every participant’s experience, and it does not by itself quantify the relative event rate between treatment groups.
The registry states that the median and its 95% confidence interval were estimated with the Kaplan-Meier method. A confidence interval communicates uncertainty around an estimate; it is not a guarantee that the true value lies within the reported limits. The posted arm results give a median and a lower confidence-interval bound, but no upper bound. A complete interval is therefore not available from the registry record. The endpoint is clinically interpretable as time without progression or death, but its interpretation depends on consistent assessment and adequate follow-up, details of which are not fully reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted median progression-free survival is 139 days for the bevacizumab and nab-paclitaxel group, with a reported lower 95% confidence-interval bound of 86 days. For the ipilimumab group, the median is 94 days, with a lower bound of 74 days. The registry does not give the upper confidence-interval bound for either group. These arm-specific estimates describe the observed time-to-event experience; they do not, on their own, establish a statistically reliable difference between treatments.
A comparison of medians is not the same as a comparison of the full time-to-event distributions. The registry record does not report a hazard ratio or a formal comparative analysis for the primary endpoint. It also does not report a p-value for the primary comparison. The registry’s indication that comparative values were missing or not estimable for this median-time endpoint is important: a difference between two posted point estimates should not be treated as a tested treatment effect. No sponsor-reported hazard ratio is available in the record for interpretation.
Uncertainty is substantial in a trial with 24 enrolled participants, with 12 assigned to each initial group. The available confidence-interval information is incomplete because the upper bounds are absent. The record also does not describe the analysis population, missing outcome data, censoring patterns, or the treatment of crossover in the primary analysis. Each of these can affect how the time-to-event results should be read. The reported arm medians should therefore be understood as descriptive estimates from the posted results, not as a complete account of comparative efficacy.
The registry includes a secondary count of participants who experienced toxicity, but the posted comparison is unadjusted and the record does not list sponsor-reported analyses for the secondary outcomes. The unadjusted p-value for that comparison is 0.386, and its confidence interval includes values on both sides of no difference. This result does not establish that the groups are equivalent; it reflects uncertainty in a small sample. Other listed secondary outcomes include overall survival and tumor response, but their numerical results are not reported in the registry record.
Overall, the registry provides descriptive results for the primary endpoint and partial reporting for secondary outcomes. It does not supply a formal comparative estimate for progression-free survival, a complete interval for either median, or enough information to reconstruct the primary analysis. The posted evidence should be interpreted with those limitations in view rather than as a definitive ranking of the treatments.
9. Statistical Methods Explained
General statistical explanation: a time-to-event analysis studies how long it takes for a defined event to occur. In this trial, the event was progression or death, whichever came first. Participants who had not experienced the event by their last observed assessment may contribute partial follow-up rather than a known event time. Such observations are commonly treated as censored in time-to-event methods. The registry does not report the number or timing of censored observations, so the degree to which censoring affects these results cannot be assessed from the record.
What the Kaplan-Meier estimate describes
The registry says Kaplan-Meier estimates were used for the median and 95% confidence intervals. In general, the Kaplan-Meier method estimates the proportion of participants who remain event-free over follow-up while accounting for participants whose event time is not observed before follow-up ends. The median is read from that estimated event-free pattern as the time when the estimated proportion event-free reaches half. It is not the arithmetic average of observed event times.
The posted median is an estimate, not an exact boundary separating participants who did and did not progress. Its precision depends on the amount and timing of information available, including events and censoring. The registry gives a lower confidence bound for each arm but no upper bound. As a result, the posted record does not provide the full stated 95% confidence interval. General explanation: a confidence interval expresses uncertainty under the assumptions of the method; a wider interval indicates less precision than a narrower one. The missing upper bounds prevent a complete interval-based assessment.
Why a median is not a comparative effect
Two arm-specific medians summarize each group separately. Their values alone do not show whether the full event-time patterns differ, nor do they account for uncertainty in a direct comparison. A comparative time-to-event analysis may report a hazard ratio, a confidence interval for that ratio, and a test of a stated hypothesis. The registry record does not report a sponsor analysis of that kind for the primary endpoint. The record therefore does not support treating the difference between the displayed medians as a formal estimate of treatment effect.
General explanation: a hazard ratio compares the instantaneous event rates between groups over follow-up under the analysis model. It is not a ratio of medians, and its interpretation can depend on whether the relative event rates are reasonably stable over time. When that assumption is not appropriate, a single hazard ratio may not capture the pattern well. The registry does not provide a hazard ratio or report whether this assumption was assessed. No conclusion about the appropriateness of a particular comparative model can be drawn from the posted information.
Randomization, crossover, and analysis
Random assignment is intended to make the initial groups comparable on average, including with respect to factors that may not have been measured. In a small trial, however, chance differences can remain. The registry reports randomization and equal group counts, but does not describe the sequence generation, allocation concealment, stratification factors, or baseline characteristics in the registry record for this analysis. Those features are not reported in the registry record.
The trial is designated as a crossover design, and both treatment descriptions allow participants experiencing progression to cross over. For a progression-free survival endpoint, progression is itself the event, so a later crossover cannot change the time at which that participant first met the primary endpoint. However, crossover can affect later outcomes such as overall survival and can complicate interpretation of treatment received after progression. The record does not report crossover counts, timing, or the approach used to analyze outcomes after crossover.
General explanation: an intention-to-treat analysis generally keeps participants in their originally randomized groups, regardless of treatment changes. An as-treated analysis instead classifies participants according to treatment received, which can weaken the protection of randomization because treatment changes may be related to health status or prognosis. The registry record does not identify the analysis population or state whether the primary analysis followed an intention-to-treat principle. It is therefore not possible to determine the primary analysis approach from the posted record.
Secondary comparisons and planning illustrations
The registry posts a count of participants experiencing toxicity and an unadjusted comparison. General explanation: an unadjusted comparison evaluates an outcome without controlling for other variables or accounting for the number of outcomes tested. With a small sample, estimates can vary substantially, and a p-value is not a measure of the size or clinical importance of an effect. A confidence interval for a risk difference communicates the range of values compatible with the data and method; when it includes no difference, the result does not rule out either direction.
The record also includes sample-size planning illustrations based on fractions of the observed toxicity effect. These are hypothetical planning calculations, not observed power and not the original trial’s design justification. The stated assumptions include a two-sided significance level of 0.05, equal allocation, and a normal approximation. The registry does not report that these assumptions were used to plan the trial, nor does it report a sample-size justification. The planning figures should not be interpreted as evidence that the enrolled trial had a particular probability of detecting an effect.
General explanation: over-dispersion occurs when variability in the data exceeds what a statistical model assumes. When present, standard errors based on the narrower variance assumption can be too small, making intervals appear more precise than warranted. The registry’s primary endpoint is time-to-event, and the posted primary results use Kaplan-Meier estimation; the record does not report an over-dispersion assessment or a model-based comparative analysis. This concept is relevant generally but cannot be diagnosed from the posted arm medians alone.
Multiplicity and incomplete reporting
The registry lists several secondary outcomes and multiple safety measures. When many outcomes are examined, the chance of obtaining an apparently notable result by chance can rise if no multiplicity strategy is used. The record does not report a multiplicity adjustment, a hierarchy of outcome tests, or a prespecified approach for handling multiple comparisons. An unadjusted secondary p-value should consequently be read as exploratory rather than as conclusive evidence.
The registry does not report interim analyses, the handling of missing outcome data, or detailed definitions and analysis populations for all outcomes. These omissions constrain independent evaluation; they do not establish that the trial lacked such procedures. They are simply not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record lists a primary endpoint and several secondary outcomes, but it does not report a statistical testing hierarchy or a plan for adjusting for multiple comparisons. Multiplicity matters because examining several outcomes can increase the chance that at least one result appears notable even when there is no underlying difference. General explanation: adjustment procedures or a prespecified hierarchy can help control that risk, but the registry record does not state that any such approach was used. The unadjusted secondary comparison should be regarded cautiously.
The registry does not report whether interim analyses were planned or conducted. It also does not report a complete statistical analysis plan, a sample-size justification, or a detailed account of the populations included in each analysis. These details are needed to assess whether analyses followed prespecified methods and whether all randomized participants were included in the relevant outcome analyses. Their absence from the record is not evidence that they were not considered by the investigators.
Information on missing data and censoring is also limited. Progression-free survival is a time-to-event outcome, but the registry does not describe the amount of censoring, reasons for loss to follow-up, or sensitivity analyses for missing outcome information. It does not specify how incomplete assessments were handled. The upper confidence-interval bounds for the primary medians are not posted, leaving the stated interval summaries incomplete.
The design allowed crossover after progression, but the record does not report the number of participants who crossed over, their crossover timing, or the analysis population and method used for each outcome. These omissions matter especially for later outcomes that may occur after participants switch treatment. In combination, the lack of reported multiplicity methods, missing-data details, analysis populations, and crossover handling limits the ability to reproduce or independently evaluate the analyses. Each item is not reported in the registry record.
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 A (Bevacizumab and Nab-paclitaxel) | 2 | 12 | 16.7% |
| Arm B (Ipilimumab) | 4 | 12 | 33.3% |
| Arm A Eligible for Crossover | 2 | 7 | 28.6% |
| Arm B Eligible for Crossover | 2 | 7 | 28.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm A (Bevacizumab and Nab-paclitaxel) | 10 of 12 |
| Arm B (Ipilimumab) | 8 of 12 |
| Arm A Eligible for Crossover | 6 of 7 |
| Arm B Eligible for Crossover | 5 of 7 |
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 A (Bevacizumab and Nab-paclitaxel) | 11 of 12 |
| Arm B (Ipilimumab) | 9 of 12 |
| Arm A Eligible for Crossover | 7 of 7 |
| Arm B Eligible for Crossover | 7 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm A (Bevacizumab and Nab-paclitaxel) | Arm B (Ipilimumab) | Arm A Eligible for Crossover | Arm B Eligible for Crossover |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | 0 of 12 | 3 of 12 | 0 of 7 | 0 of 7 |
| Hemolytic uremic syndrome | Blood and lymphatic system disorders | 1 of 12 | 0 of 12 | 1 of 7 | 0 of 7 |
| Neoplasms benign, mal, uncpec - Oth spec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 12 | 2 of 12 | 0 of 7 | 0 of 7 |
| Rectal hemorrhage | Gastrointestinal disorders | 1 of 12 | 0 of 12 | 0 of 7 | 0 of 7 |
| Wound dehiscence | Injury, poisoning and procedural complications | 0 of 12 | 0 of 12 | 0 of 7 | 1 of 7 |
| Creatinine increased | Investigations | 0 of 12 | 0 of 12 | 1 of 7 | 0 of 7 |
| Lymphocyte count decreased | Investigations | 0 of 12 | 1 of 12 | 0 of 7 | 0 of 7 |
| Platelet count decreased | Investigations | 0 of 12 | 0 of 12 | 1 of 7 | 0 of 7 |
| Dehydration | Metabolism and nutrition disorders | 0 of 12 | 0 of 12 | 1 of 7 | 0 of 7 |
| Peripheral sensory neuropathy | Nervous system disorders | 0 of 12 | 0 of 12 | 0 of 7 | 1 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm A (Bevacizumab and Nab-paclitaxel) | Arm B (Ipilimumab) | Arm A Eligible for Crossover | Arm B Eligible for Crossover |
|---|---|---|---|---|---|
| Fatigue | General disorders | 6 of 12 | 2 of 12 | 3 of 7 | 6 of 7 |
| Neutrophil count decreased | Investigations | 9 of 12 | 0 of 12 | 1 of 7 | 4 of 7 |
| White blood cell decreased | Investigations | 8 of 12 | 0 of 12 | 1 of 7 | 3 of 7 |
| Alopecia | Skin and subcutaneous tissue disorders | 6 of 12 | 0 of 12 | 1 of 7 | 4 of 7 |
| Hypertension | Vascular disorders | 5 of 12 | 2 of 12 | 0 of 7 | 2 of 7 |
| Abdominal pain | Gastrointestinal disorders | 0 of 12 | 3 of 12 | 2 of 7 | 3 of 7 |
| Anemia | Blood and lymphatic system disorders | 1 of 12 | 1 of 12 | 1 of 7 | 2 of 7 |
| Diarrhea | Gastrointestinal disorders | 2 of 12 | 0 of 12 | 2 of 7 | 1 of 7 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 3 of 12 | 0 of 12 | 1 of 7 | 1 of 7 |
| Myalgia | Musculoskeletal and connective tissue disorders | 1 of 12 | 1 of 12 | 1 of 7 | 1 of 7 |
Serious events with the highest arm-level rate: acute kidney injury (25.0%), neoplasms benign, mal, uncpec - oth spec (16.7%), hemolytic uremic syndrome (14.3%), wound dehiscence (14.3%), creatinine increased (14.3%).
The registry reports serious adverse event counts among participants at risk in each initial arm, along with counts for other adverse events and deaths. These are descriptive counts, not proof that a treatment caused an event. The registry record does not provide enough detail in the registry record to determine attribution, timing, duration, or the specific criteria used to classify every event.
It separately reports safety figures for groups described as eligible for crossover. Those entries should be read as separate registry groupings; they should not be added to the initial-arm counts or treated as independent randomized groups without further information. The record does not explain the relationship between the crossover-eligible groups and the full initial groups beyond their labels and counts.
The registry also lists serious-event terms with percentages, including acute kidney injury and several other coded terms. It does not give the term-specific participant counts or clearly report the denominator used for each percentage in the registry record. The percentages should therefore be treated as registry summaries rather than as rates that can be compared directly across arms. The death counts in the safety record do not establish that deaths were caused by treatment. No causal conclusion about safety can be drawn from these counts alone.
12. What the Result Does, and Does Not, Mean
The results describe a small randomized phase II comparison in which the registry posts arm-specific progression-free survival medians and incomplete confidence-interval information. They provide a snapshot of the observed time-to-event results for participants in each initial treatment group. The registry does not provide a reported comparative estimate for the primary endpoint, so the posted medians do not establish a statistically reliable difference between the strategies.
These results do not establish that one treatment is superior, equivalent, or inferior to the other. Failure to report a formal comparison is not the same as finding no difference. Likewise, the unadjusted secondary toxicity comparison cannot establish equivalence or exclude differences, particularly given the small number of participants and the interval’s uncertainty. Numerical results for some listed secondary outcomes are not reported in the registry record.
The findings also should not be generalized automatically to every person with melanoma. The registry describes a selected population with unresectable stage IV disease and lists several melanoma subtypes, but it does not provide the participant characteristics needed to judge how closely the enrolled group represents a broader clinical population. The treatment schedules, eligibility criteria, follow-up, and analysis details also influence what can be inferred.
General statistical explanation: a trial estimate is most useful when interpreted with its uncertainty, analysis methods, and study design. A point estimate alone can appear more decisive than the underlying evidence warrants. In this record, incomplete confidence intervals, no reported primary comparative estimate, and limited reporting of analysis methods leave uncertainty about both the size and precision of any between-group difference.
The registry results are best read as descriptive evidence from this trial, not as a stand-alone basis for treatment decisions or a general claim about treatment effects. The record does not report enough detail to resolve questions about missing data, crossover handling, analysis populations, or multiplicity. These limits are relevant to the strength of inference, not proof that particular procedures were or were not carried out.
13. Why This Trial Matters Statistically
This trial illustrates why a randomized label and arm-specific outcome summaries are not enough to interpret a comparative study. Randomization is designed to support fair comparisons, but the reported analysis must still quantify the between-group contrast and its uncertainty. The registry posts a median for each group, yet it does not report a formal comparative estimate for the primary time-to-event outcome. A reader cannot substitute a visual or arithmetic comparison of the medians for that missing analysis.
The record also demonstrates the importance of complete uncertainty reporting. It identifies 95% confidence intervals for the primary medians but posts only lower bounds. Without the upper bounds, readers cannot assess the intervals as complete summaries of precision. Reporting both a clear estimate and its full uncertainty is essential when trial enrollment is limited.
The crossover design adds another statistical consideration. Progression triggered the primary endpoint and could also lead to a treatment switch. That switch is relevant to later outcomes and must be understood through a stated analysis strategy. The registry does not report the crossover counts or analysis approach, so the implications for outcomes after progression cannot be evaluated from the record.
Finally, the secondary outcome information highlights the difference between exploratory signals and confirmatory evidence. The registry does not report a multiplicity plan, a testing hierarchy, or sponsor analyses for the secondary outcomes. An unadjusted result among several outcomes should not carry the same weight as a prespecified, fully reported primary comparison. These are general lessons in interpreting clinical trial records, not conclusions about unreported investigator procedures.
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 the registry results for this trial. Enrollment was 24, with 12 participants listed in each initial arm. Estimates from groups of this size are inherently imprecise, and the record’s primary confidence-interval information is incomplete because upper bounds are absent. The registry also does not report a formal between-arm estimate for progression-free survival, so the primary results remain descriptive.
The study allowed crossover after progression, but the registry does not report how many participants crossed over, when crossover occurred, or how it was handled analytically. This limits interpretation of later outcomes and prevents assessment of whether crossover affected the posted analyses. The record does not report the analysis populations, missing-data procedures, censoring patterns, baseline characteristics, or the extent of follow-up by arm.
Although overall survival and tumor response are listed as secondary outcomes, their numerical results are not reported in the registry record. The toxicity outcome has an unadjusted comparison, and no multiplicity strategy or secondary-outcome hierarchy is reported. These gaps limit the ability to assess the consistency of results across outcomes. The registry does not report interim analysis methods or the original sample-size justification.
The study was unmasked, and the record does not describe the procedures used to assess progression or manage potential assessment bias. This is a design consideration, not evidence that assessments were biased. The treatment descriptions give schedules and crossover intent, but do not provide all details needed to reconstruct adherence, treatment exposure, or post-progression care. Consequently, the posted record supports a limited description of the trial, rather than a comprehensive independent evaluation of its methods or comparative findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Nab-Paclitaxel and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery — NCT02158520.
- Registry record last updated 2020-01-21; status last verified 2019-02.
- Results first posted 2020-01-02.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02158520 is a completed randomized phase II trial of nab-paclitaxel plus bevacizumab versus ipilimumab as first-line therapy for unresectable stage IV melanoma. The registry lists 24 participants, with 12 in each initial arm, and describes the study as unmasked and crossover. The primary outcome was progression-free survival, defined as time from randomization to progression under RECIST version 1.1 or death.
The registry posts arm-specific median progression-free survival estimates, but gives only lower confidence-interval bounds and does not report a formal comparative estimate for the primary endpoint. Toxicity is listed among the secondary outcomes; numerical results for overall survival and tumor response are not reported in the registry record. The record also does not report a complete analysis plan, analysis populations, missing-data methods, multiplicity handling, or crossover analysis details. The results therefore provide a limited descriptive account and do not establish a definitive comparative treatment effect.