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-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC) (NCT01354431), a randomized phase 2 study. The primary outcome is Progression Free Survival (PFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01354431 |
| Phase | Phase 2 |
| Condition | Renal Cell Carcinoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 168 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Bristol-Myers Squibb |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled participants with progressive, advanced or metastatic clear-cell renal cell carcinoma who had received prior anti-angiogenic therapy. The primary endpoint population is all randomized participants. The registry lists an enrollment of 168.
Intervention
Participants were assigned to nivolumab at 0.3 mg/kg, 2 mg/kg, or 10 mg/kg. These are dose groups for the same biological intervention, rather than comparisons between different drugs.
Comparator
The registry records the 0.3 mg/kg nivolumab group as the reference group for the posted arm-level summaries. The study is dose-ranging; no placebo or non-nivolumab group is listed.
Primary question
The primary question is how long participants remain alive without investigator-assessed disease progression in each dose group, and whether the pattern across doses is consistent with a dose response. The registry reports median progression-free survival with 80% confidence intervals, but no formal primary comparison between doses.
3. Trial Design
This was a randomized, blinded, phase 2, parallel-group dose-ranging study sponsored by Bristol-Myers Squibb. The registry marks masking as triple. The study compared three nivolumab dose groups: 0.3 mg/kg, 2 mg/kg, and 10 mg/kg. It did not include a listed placebo or a different active treatment arm, so the central contrast is between dose levels of nivolumab.
The official title describes participants as having progressive, advanced or metastatic clear-cell renal cell carcinoma after prior anti-angiogenic therapy. The registry lists Renal Cell Carcinoma as the condition. Enrollment is recorded as 168, and the study status is completed. The recorded start date is 2011-05-31 and the primary completion date is 2013-05-15.
The primary endpoint was progression-free survival (PFS) in all randomized participants. The registry defines its timeframe as randomization until disease progression or death, up to approximately 2 years. It describes investigator assessment of clinical or radiographic progression, with radiographic scans every 6 weeks from randomization for the first 12 months and then every 12 weeks until progression. Survival was assessed every 3 months.
The registry says the PFS analysis was conducted after approximately 116 progression-or-death events, approximately 2 years. It does not report the rationale for the selected doses, allocation ratio, sequence-generation details, or a sample-size justification. Those design details should not be inferred from the reported arm sizes or endpoint results.
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: 168 participants were randomized, 167 participants were treated.
Pre-Treatment Period
| Stage | Nivolumab 0.3 mg/kg | Nivolumab 2 mg/kg | Nivolumab 10 mg/kg |
|---|---|---|---|
| STARTED | 60 | 54 | 54 |
| COMPLETED | 59 | 54 | 54 |
| NOT COMPLETED | 1 | 0 | 0 |
Reasons for not completing this period:
| Reason | Nivolumab 0.3 mg/kg | Nivolumab 2 mg/kg | Nivolumab 10 mg/kg |
|---|---|---|---|
| Not reported | 1 | 0 | 0 |
Treatment Period
| Stage | Nivolumab 0.3 mg/kg | Nivolumab 2 mg/kg | Nivolumab 10 mg/kg |
|---|---|---|---|
| STARTED | 59 | 54 | 54 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 59 | 54 | 54 |
Reasons for not completing this period:
| Reason | Nivolumab 0.3 mg/kg | Nivolumab 2 mg/kg | Nivolumab 10 mg/kg |
|---|---|---|---|
| Disease Progression | 50 | 40 | 44 |
| Study Drug Toxicity | 5 | 8 | 4 |
| Death | 0 | 1 | 0 |
| AE unrelated to study drug | 1 | 2 | 5 |
| Participant request to discontinue | 2 | 2 | 1 |
| Participant withdrew consent | 0 | 1 | 0 |
| Participant no longer meeting study criteria | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All Randomized participants were included.
| Characteristic | Unit | Nivolumab 0.3 mg/kg | Nivolumab 2 mg/kg | Nivolumab 10 mg/kg | Total |
|---|---|---|---|---|---|
| Participants analysed | 60 | 54 | 54 | 168 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 37 | 41 | 35 | 113 |
| Age, Categorical: >=65 years | Participants | 23 | 13 | 19 | 55 |
| Age, Continuous | years | 61.0 (SD 8.8) | 60.8 (SD 8.2) | 60.6 (SD 9.6) | 60.8 (SD 8.8) |
| Sex: Female, Male: Female | Participants | 19 | 14 | 14 | 47 |
| Sex: Female, Male: Male | Participants | 41 | 40 | 40 | 121 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 53 | 53 | 54 | 160 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 7 | 1 | 0 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Progression Free Survival (PFS), measured over From randomization to disease progression or death (up to approximately 2 years).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 80% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
PFS measures the time from randomization until the first recorded disease progression or death. In this trial, progression could be clinical or radiographic and was determined by the investigator. If progression did not occur, death was used as the endpoint event. This definition combines disease worsening and death into a time-to-event outcome.
The registry reports median PFS in months for each nivolumab dose group. A median describes the time by which the estimated event-time distribution has reached its midpoint; it is not the average participant’s individual time and does not describe every participant’s course. The accompanying 80% confidence interval communicates uncertainty around the estimated median. It is not a range containing the PFS times of most participants.
PFS is used in clinical trials because it summarizes how long participants remain alive without recorded progression, while incorporating follow-up over time rather than treating every participant’s observation as complete. Its interpretation depends on how progression is defined, how often assessments occur, and how censoring and incomplete follow-up are handled. The registry describes the assessment schedule and event definition, but does not report its censoring or missing-data procedures.
The posted primary results are arm-level medians and confidence intervals. They do not, by themselves, establish a statistically supported difference between doses. Formal dose comparisons, hazard ratios, and a reported primary hypothesis test are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
Median PFS was 2.63 months for nivolumab 0.3 mg/kg, with an 80% confidence interval from 1.81 to 3.02 months. For 2 mg/kg, the median was 4.11 months, with an 80% confidence interval from 2.86 to 5.39 months. For 10 mg/kg, it was 4.17 months, with an 80% confidence interval from 2.79 to 5.49 months. These are the registry’s arm-level summaries, not estimates of a causal difference between doses.
The two higher-dose medians are numerically greater than the 0.3 mg/kg median, while the 2 mg/kg and 10 mg/kg medians are close to each other. The confidence intervals overlap. Overlap alone is not a formal test of equality, and the registry does not report a primary between-dose comparison, hazard ratio, or p-value for PFS. The results therefore describe the observed pattern but do not establish whether the differences are compatible with chance variation or support a dose-response relationship.
The confidence intervals are 80%, as specified in the registry. A confidence interval expresses uncertainty in an estimated quantity under the analysis assumptions; it is not a guarantee about an individual participant’s outcome. These intervals also do not show the spread of participant-level PFS times. The registry does not report the methods used to calculate the intervals, so their construction should not be assumed.
The primary endpoint was assessed in all randomized participants, and the registry describes progression as investigator-assessed clinical or radiographic progression, or death. The stated analysis timing was after approximately 116 events, approximately 2 years. The record does not provide a fuller account of follow-up completeness, censoring, or the treatment of missing assessments. Those details matter when interpreting time-to-event estimates.
The registry lists 168 enrolled participants, while the endpoint summaries have arm-level denominators of 60.0, 54.0, and 54.0. These recorded values describe the groups associated with the outcome summaries; they should not be treated as a substitute for a reported flow of participants through follow-up. The registry record does not report that flow or explain any difference between enrollment and endpoint denominators.
In short, the posted results show higher median PFS estimates in the 2 mg/kg and 10 mg/kg groups than in the 0.3 mg/kg group, with similar medians in the two higher-dose groups. They do not establish a statistically supported difference or a dose-response effect. The absence of a reported primary comparison is important: arm-level estimates and intervals are descriptive evidence, not a replacement for the planned inferential analysis.
9. Statistical Methods Explained
The primary endpoint is time-to-event data. Each participant’s observed follow-up contributes information about the time until progression or death, or about the period during which the participant was known to remain free of those events. In general, time-to-event methods can retain partial follow-up for participants whose event has not been observed by the end of observation. The registry does not report the censoring rules or analysis procedure used for this trial, so the details of that handling are not reported in the registry record.
What does a median PFS estimate describe?
A median is a feature of the estimated distribution of event times. It identifies the point at which the estimated proportion remaining event-free reaches its midpoint. It does not mean that every participant experiences progression or death at that time, and it does not describe the time for an individual participant. The reported medians are 2.63 months, 4.11 months, and 4.17 months for the 0.3 mg/kg, 2 mg/kg, and 10 mg/kg groups, respectively.
Because the endpoint includes progression or death, the event is not limited to radiographic tumor growth. The registry specifies investigator-assessed clinical or radiographic progression and uses death when progression has not occurred. A participant’s event time therefore depends on the endpoint definition and assessment process, as well as the underlying clinical course.
How should the confidence intervals be read?
The registry reports 80% confidence intervals for the median PFS estimates. In general, a confidence interval describes uncertainty in an estimate under the assumptions of the statistical method. A narrower interval indicates greater precision than a wider interval on the same scale, while neither interval describes the range of individual outcomes. The intervals are 1.81 to 3.02 months, 2.86 to 5.39 months, and 2.79 to 5.49 months for the respective dose groups. The interval level is 80%, not 95%. The method used to construct these intervals is not reported in the registry record.
Confidence intervals around separate group medians do not directly provide a confidence interval for the difference between groups. Their overlap is not itself a formal test. A comparison would require an analysis designed to estimate a between-group contrast and quantify its uncertainty. No PFS contrast, hazard ratio, or primary comparison test is reported in the registry record, and the registry lists zero posted analyses.
Why does the event count matter?
Time-to-event analyses rely on the timing of events and the amount of follow-up. The registry says the PFS analysis was conducted after approximately 116 events, defined as progression or death, approximately 2 years. This gives context for when the analysis was undertaken, but does not supply a complete account of event ascertainment, censoring, follow-up duration by group, or missing assessments. The analysis timing should not be interpreted as evidence that all randomized participants had complete follow-up.
What can be learned from the secondary response-rate comparisons?
Best overall response rate is reported as a percentage of participants. It is a binary outcome: each participant is classified according to whether the response criterion was met during the specified period. The registry lists response rates of 20.0% for 0.3 mg/kg, 24.1% for 2 mg/kg, and 20.4% for 10 mg/kg, each with an 80% confidence interval. The registry does not post sponsor analyses for these outcomes.
Separate unadjusted risk-difference calculations are listed for the higher-dose groups relative to 0.3 mg/kg. These are recalculated from the posted summary counts and are not sponsor-reported analyses. For 2 mg/kg, the recalculated risk difference is 0.041 with an interval from -0.112 to 0.193 and p = 0.6. For 10 mg/kg, it is 0.004 with an interval from -0.144 to 0.151 and p = 0.961. These results are unadjusted and should not be read as prespecified confirmatory findings. The record reports no sponsor analyses, and no multiplicity procedure is reported.
Planning estimates associated with the response-rate comparisons are illustrations, not observed power and not evidence that the original trial was designed for those effects. The registry states that the planning calculations assume a two-sided significance level of 0.05, equal allocation between the compared arms, and a normal approximation. The assumed target effect is a stated fraction of the observed effect. The resulting participant counts are per arm. They depend strongly on the effect used and should not be treated as a redesign recommendation or as a result observed in this trial.
Why can over-dispersion matter in general?
In general, over-dispersion occurs when observed variability exceeds what a statistical model assumes. If a model underestimates variability, standard errors can be too small and confidence intervals too narrow. This concept is relevant to some count and clustered-data models, but the registry does not identify an over-dispersion model for these PFS results. It would be inappropriate to infer that such a method was used or needed in this analysis.
More broadly, a statistical method can only be fully assessed when the analysis population, estimand, model, missing-data rules, and prespecified testing strategy are described. The registry establishes the endpoint definition, assessment schedule, arm-level estimates, and analysis timing, but several of those analytic details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies PFS as the primary outcome and lists best overall response rate, overall survival, and the number of participants experiencing adverse events as secondary outcomes. It does not report a multiplicity adjustment, a testing hierarchy, or which secondary comparisons, if any, were intended to be confirmatory. The registry lists zero posted analyses. The response-rate comparisons available in the record are unadjusted recalculations rather than sponsor-reported analyses.
Multiplicity matters when several outcomes or group contrasts are examined. In general, the more statistical questions considered, the greater the chance that at least one result appears unusual even when there is no underlying effect. A prespecified testing strategy can help distinguish confirmatory tests from exploratory findings. Since such a strategy is not reported in the registry record, the secondary p-values should be interpreted cautiously and should not be treated as independently confirmed findings.
The primary population is described as all randomized participants. The registry does not state the analysis population for each secondary outcome, or whether any participants were excluded from particular analyses. Arm-level denominators are reported for outcome summaries, but participant disposition and reasons for any unavailable outcomes are not reported in the registry record.
The record does not describe missing-data methods, censoring rules, or the handling of incomplete tumor assessments. These details can influence time-to-event estimates and binary response summaries. For PFS, the registry does specify the endpoint event and assessment schedule, but that information does not establish how participants without a recorded event were handled statistically.
The registry also does not report a sample-size justification or the assumptions used to plan the original trial. The later planning illustrations associated with response-rate comparisons are based on the observed effect and stated calculation assumptions; they are not the original design rationale. No interim-analysis plan is reported in the registry record. Consequently, claims about planned power, interim monitoring, or the adjustment of tests over time cannot be made from the posted 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 |
|---|---|---|---|
| NIVOLUMAB 0.3 mg/kg | 30 | 59 | 50.8% |
| NIVOLUMAB 2 mg/kg | 35 | 54 | 64.8% |
| NIVOLUMAB 10 mg/kg | 24 | 54 | 44.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| NIVOLUMAB 0.3 mg/kg | 51 of 60 |
| NIVOLUMAB 2 mg/kg | 46 of 54 |
| NIVOLUMAB 10 mg/kg | 47 of 54 |
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 |
|---|---|
| NIVOLUMAB 0.3 mg/kg | 55 of 59 |
| NIVOLUMAB 2 mg/kg | 54 of 54 |
| NIVOLUMAB 10 mg/kg | 52 of 54 |
Most frequent serious adverse event terms
| Event term | Organ system | NIVOLUMAB 0.3 mg/kg | NIVOLUMAB 2 mg/kg | NIVOLUMAB 10 mg/kg |
|---|---|---|---|---|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 6 of 59 | 5 of 54 | 3 of 54 |
| Anaemia | Blood and lymphatic system disorders | 3 of 59 | 2 of 54 | 1 of 54 |
| Pneumonia | Infections and infestations | 1 of 59 | 3 of 54 | 2 of 54 |
| Spinal cord compression | Nervous system disorders | 2 of 59 | 4 of 54 | 0 of 54 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 2 of 59 | 1 of 54 | 3 of 54 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 2 of 59 | 1 of 54 | 3 of 54 |
| Dehydration | Metabolism and nutrition disorders | 1 of 59 | 2 of 54 | 2 of 54 |
| Acute kidney injury | Renal and urinary disorders | 3 of 59 | 2 of 54 | 0 of 54 |
| Nausea | Gastrointestinal disorders | 2 of 59 | 1 of 54 | 1 of 54 |
| Hypercalcaemia | Metabolism and nutrition disorders | 3 of 59 | 1 of 54 | 0 of 54 |
Most frequent non-serious adverse event terms
| Event term | Organ system | NIVOLUMAB 0.3 mg/kg | NIVOLUMAB 2 mg/kg | NIVOLUMAB 10 mg/kg |
|---|---|---|---|---|
| Fatigue | General disorders | 25 of 59 | 25 of 54 | 29 of 54 |
| Cough | Respiratory, thoracic and mediastinal disorders | 20 of 59 | 20 of 54 | 11 of 54 |
| Back pain | Musculoskeletal and connective tissue disorders | 12 of 59 | 17 of 54 | 17 of 54 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 10 of 59 | 18 of 54 | 16 of 54 |
| Constipation | Gastrointestinal disorders | 13 of 59 | 19 of 54 | 11 of 54 |
| Nausea | Gastrointestinal disorders | 16 of 59 | 15 of 54 | 12 of 54 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 15 of 59 | 11 of 54 | 10 of 54 |
| Diarrhoea | Gastrointestinal disorders | 9 of 59 | 10 of 54 | 16 of 54 |
| Oedema peripheral | General disorders | 14 of 59 | 10 of 54 | 11 of 54 |
| Decreased appetite | Metabolism and nutrition disorders | 8 of 59 | 15 of 54 | 11 of 54 |
Serious events with the highest arm-level rate: malignant neoplasm progression (10.2%), spinal cord compression (7.4%), pneumonia (5.6%), dyspnoea (5.6%), pulmonary embolism (5.6%).
The registry reports serious adverse events for each dose group using the listed at-risk denominators: 30 of 59 participants in the 0.3 mg/kg group, 35 of 54 in the 2 mg/kg group, and 24 of 54 in the 10 mg/kg group. For other adverse events, the corresponding reported counts are 55 of 59, 54 of 54, and 52 of 54. These are descriptive counts within the registry’s recorded groups; they do not by themselves establish a causal relationship to nivolumab or show whether the groups differ statistically.
The registry lists serious adverse-event terms and percentages, including malignant neoplasm progression at 10.2%, spinal cord compression at 7.4%, pneumonia at 5.6%, dyspnoea at 5.6%, pulmonary embolism at 5.6%, and anaemia at 5.1%. These percentages should be read as registry-reported event summaries. The record does not provide a comparison test for these terms or explain their relationship to treatment exposure and follow-up.
Deaths are also recorded as 51, 46, and 47 across the respective groups. The registry does not provide further detail in this record to classify their causes or establish treatment attribution. Safety counts describe reported events, not comparative risk estimates adjusted for exposure or follow-up.
12. What the Result Does, and Does Not, Mean
The primary results describe median PFS within each nivolumab dose group. The medians were 2.63 months for 0.3 mg/kg, 4.11 months for 2 mg/kg, and 4.17 months for 10 mg/kg. The corresponding 80% confidence intervals are 1.81 to 3.02 months, 2.86 to 5.39 months, and 2.79 to 5.49 months. The estimates show a numerically higher median in the two higher-dose groups than in the 0.3 mg/kg group, and similar medians for the two higher doses.
These arm-level results do not establish that one dose differs from another. No formal PFS comparison, hazard ratio, or primary p-value is reported in the registry record. The intervals communicate uncertainty about each median, but do not directly estimate a difference between groups. Their overlap is not a test of whether the groups are the same.
The trial’s dose-ranging aim included asking whether a dose-response relationship existed. The posted medians alone cannot answer that question. A convincing assessment would require an appropriate comparative analysis and its uncertainty, together with the analysis plan and relevant details of follow-up and missing observations. Those elements are not reported in the registry record.
The response-rate results offer additional descriptive context, but the registry does not report sponsor analyses for the secondary outcomes, and the available risk-difference calculations are unadjusted. Numerical overall-survival results are not reported in the registry record. Safety counts and listed event terms provide information about reported adverse events, but do not establish causality or comparative safety.
Accordingly, these results describe what was recorded for the trial’s dose groups. They do not, on their own, determine whether a dose is preferable, whether a treatment should be used, or whether the observed differences would persist in another population. Clinical decisions require evidence and context beyond the arm-level estimates in this registry record.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it compares dose levels of the same intervention rather than comparing an intervention with placebo or a different treatment. A dose-ranging study raises a question about the shape of the relationship between dose and outcome. A higher outcome estimate at a higher dose does not by itself demonstrate a monotonic dose response, especially when the top-dose and middle-dose estimates are close and formal comparisons are absent.
The primary outcome is time-to-event, so its interpretation depends on event definitions, assessment timing, and follow-up. The registry gives useful detail about investigator-assessed progression, scan frequency, the use of death as an event, and the approximate event count at analysis. At the same time, it does not report the statistical procedures for censoring, confidence-interval construction, or the primary between-group comparison. This illustrates why a clear endpoint definition is necessary but not sufficient for evaluating an analysis.
The response-rate summaries also show why effect estimates should be considered with their uncertainty. A difference in observed percentages is not itself evidence of a reliable treatment contrast. The unadjusted recalculations have broad intervals and are not sponsor-reported analyses. Planning calculations based on observed effects can be useful for illustrating how assumed effect size affects required sample size, but they are not observed power and do not describe the rationale for this trial’s enrollment.
Finally, the record distinguishes what was measured from what can be inferred. It records PFS, response, survival as a secondary outcome, and adverse events, but reports no sponsor analyses for the secondary outcomes. Missing details on multiplicity, missing data, and analysis populations constrain interpretation. These limits are not merely administrative: they determine how confidently descriptive patterns can be separated from chance and how well the analysis can be reproduced.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation in interpreting PFS is that the registry reports arm-level medians and 80% confidence intervals but no formal comparison between dose groups. It does not report hazard ratios, a primary p-value, or the statistical method used to estimate the medians and intervals. This prevents direct assessment of the estimated comparative effect and its precision.
The registry gives an endpoint definition and assessment schedule, but does not describe censoring rules, missing tumor assessments, or the handling of incomplete follow-up. Nor does it report participant disposition by arm. The outcome denominators are available, but their relationship to the enrollment record is not explained. This leaves uncertainty about the extent and pattern of unavailable outcome data.
The record does not report a multiplicity plan, a hierarchy of secondary outcomes, or sponsor analyses for the listed secondary endpoints. The response-rate comparisons are unadjusted recalculations from posted summaries. Their interpretation is therefore exploratory, particularly in the absence of a stated testing strategy. Overall-survival results are not reported in the registry record.
The trial compares nivolumab dose groups only, so the registry results do not provide a concurrent comparison with placebo or another treatment. The official title specifies a selected population with progressive advanced or metastatic clear-cell renal cell carcinoma after prior anti-angiogenic therapy; results should not automatically be generalized beyond that population.
Finally, the record does not report the original sample-size justification, analysis plan, or interim-analysis plan. The response-rate planning illustrations use the observed effect and stated assumptions rather than documenting the trial’s original design. These omissions limit reconstruction of the prespecified statistical intent and make it difficult to distinguish planned analyses from exploratory ones.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC) — NCT01354431.
- Registry record last updated 2022-05-12; status last verified 2022-05.
- Results first posted 2015-10-20.
- 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
NCT01354431 is a completed randomized, triple-masked, parallel-group phase 2 study sponsored by Bristol-Myers Squibb. It compared nivolumab at 0.3 mg/kg, 2 mg/kg, and 10 mg/kg in participants with progressive advanced or metastatic clear-cell renal cell carcinoma who had received prior anti-angiogenic therapy. The registry records enrollment of 168, a start date of 2011-05-31, and a primary completion date of 2013-05-15.
The primary endpoint was investigator-assessed PFS, defined from randomization to progression or death. Median PFS was 2.63 months, 4.11 months, and 4.17 months across the respective dose groups, with 80% confidence intervals reported for each. The registry does not report a formal primary comparison or hazard ratios. Secondary outcomes include response rate, overall survival, and adverse events; sponsor analyses and numerical overall-survival results are not reported in the registry record. Interpretation is limited by missing detail on multiplicity, missing data, censoring, and the original analysis plan.