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 An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma (NCT03029780), a randomized phase 2 study. The primary outcome is The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination Period.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03029780 |
| Phase | Phase 2 |
| Condition | Renal Cell Carcinoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 104 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Bristol-Myers Squibb |
| Results posted | Yes |
2. Clinical Question
Population
Participants with renal cell carcinoma who received study treatment. The primary outcome population is described as all treated participants. The registry record does not report further eligibility details in the information available for this analysis.
Intervention
Arm A used fixed-ratio co-administration of nivolumab and ipilimumab. The study’s intervention names are Opdivo and Yervoy.
Comparator
Arm B used sequential administration of nivolumab and ipilimumab. The trial was randomized, parallel-group, and unmasked.
Primary question
Was the percentage of treated participants with an adverse event in the broad-scope MedDRA Anaphylactic Reaction SMQ within 2 days after any combination-period dose different between the fixed-ratio and sequential regimens? This is a safety comparison over the specified treatment period, not a test of whether either regimen is effective against renal cell carcinoma.
3. Trial Design
This phase 2 study randomized participants with renal cell carcinoma to one of two nivolumab plus ipilimumab administration regimens. Arm A was the fixed-ratio combination, described in the arm information as co-administration. Arm B was the sequential combination. The design was parallel-group and unmasked, meaning participants were assigned to one regimen and the study was not described as masked.
The registry record reports enrollment of 104. Each arm’s posted primary-outcome population is 52 treated participants. The primary outcome was assessed in all treated participants, according to the registry description. The record gives a study start date of 2017-02-16, a primary completion date of 2017-11-27, and a completed status. Its primary-outcome timeframe describes assessment from randomization to 2 days after any dose in the combination period, up to November 24th, 2017, approximately 9 months.
The primary question concerned a specific safety event: an adverse event classified within the broad-scope MedDRA Anaphylactic Reaction SMQ and occurring on the day of or within 2 days after any study-therapy infusion during the combination period. Other listed outcomes included a narrow-scope version of the anaphylactic-reaction outcome, grade 3-5 adverse events, objective response rate, progression-free survival, and drug concentration measures. The registry record lists 8 outcome measures and 7 secondary outcomes as posted.
The registry record does not report additional details about allocation procedures, eligibility criteria, masking of outcome assessors, or the rationale for the chosen enrollment. Those details should not be inferred from the randomized, parallel, unmasked design description alone.
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: 104 participants were randomized and treated
Overall Study
| Stage | Arm A: Fixed Ratio Combination | Arm B: Sequential Combination |
|---|---|---|
| STARTED | 52 | 52 |
| COMPLETED | 1 | 1 |
| NOT COMPLETED | 51 | 51 |
Reasons for not completing this period:
| Reason | Arm A: Fixed Ratio Combination | Arm B: Sequential Combination |
|---|---|---|
| Disease Progression | 20 | 22 |
| Study Drug Toxicity | 15 | 11 |
| Adverse Event Unrelated to Study Drug | 2 | 3 |
| Participant request to discontinue study treatment | 4 | 1 |
| Maximum clinical benefit | 1 | 0 |
| Participant no longer meets study criteria | 0 | 1 |
| Other reasons | 6 | 6 |
| Not reported | 1 | 1 |
| Death | 2 | 6 |
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.
Population: All treated participants.
| Characteristic | Unit | Arm A: Fixed Ratio Combination | Arm B: Sequential Combination | Total |
|---|---|---|---|---|
| Participants analysed | 52 | 52 | 104 | |
| Age, Continuous | Years | 62.2 (SD 10.9) | 62.6 (SD 9.9) | 62.4 (SD 10.4) |
| Sex: Female, Male: Female | Participants | 10 | 14 | 24 |
| Sex: Female, Male: Male | Participants | 42 | 38 | 80 |
| Race/Ethnicity, Customized: White | Count of participants | 46 | 51 | 97 |
| Race/Ethnicity, Customized: Black or African American | Count of participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Asian | Count of participants | 3 | 0 | 3 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Count of participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Count of participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Other | Count of participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination Period, measured over From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of treated participants who experienced at least one adverse event in the broad-scope MedDRA Anaphylactic Reaction Standardized MedDRA Query. To qualify, the event had to begin on the day of, or within 2 days after, any study-therapy infusion during the combination period. The timeframe is described as extending from randomization to 2 days following any dose in that period, with assessment up to November 24th, 2017, approximately 9 months.
This endpoint turns a time- and event-specific safety definition into a participant-level binary outcome: each treated participant either had at least one qualifying event or did not. Reporting a percentage makes the frequency interpretable in relation to the treated group, while the confidence interval conveys uncertainty around that estimate. The endpoint is about the occurrence of a defined adverse event, not its severity, cause, or effect on cancer outcomes.
The broad-scope query is distinct from the listed secondary outcome using the narrow-scope query. Results for one scope should not be treated as results for the other. The registry record does not provide further detail about the query terms or adjudication process, so those should not be assumed.
7. Results Posted in the Registry
- Arm B: Sequential Combination: 11.5% (6/52) versus 11.5% (6/52) on control; risk difference 0.0 percentage points (95% CI -12.3 to 12.3), risk ratio 1.00 (0.34–2.90); unadjusted two-proportion z-test p = 1.000.
Risk difference: Arm B: Sequential Combination
95% CI: -12.3 to 12.3 percentage points
Recalculated from the posted summary statistics
8. Statistical Interpretation
The posted primary-outcome percentage was 11.5% in Arm A and 11.5% in Arm B. Each arm’s 95% confidence interval was 4.4% to 23.4%. The posted counts are 6 participants with the qualifying event in each arm, with 52 treated participants in each arm. These results describe the observed frequency of the defined event during the specified combination-period window.
The estimated risk difference for Arm B relative to Arm A was 0.0, with a 95% confidence interval from -12.3 to 12.3 percentage points in the sponsor-reported analysis. The unadjusted recalculation gives a risk difference of 0.0, and its unadjusted p-value is 1.0. The posted results therefore show no observed difference in the number of participants meeting the endpoint. They do not establish that the regimens are equivalent or that their true event frequencies are identical.
The confidence interval is important to that interpretation. It spans differences favoring either arm and is wide enough to include potentially meaningful differences in either direction. Thus, an estimate centered at zero does not mean that the comparison is precise. The individual arm confidence intervals also extend from 4.4% to 23.4%, illustrating uncertainty in the estimated percentage for each regimen.
The sponsor also reported a Cochran-Mantel-Haenszel odds ratio of 1.00, with a 95% confidence interval from 0.30 to 3.39. The registry record does not report a p-value for that analysis. The odds ratio interval includes values on either side of 1.00 and is broad, so it does not support a precise claim about the relative odds. This odds ratio analysis is not the same measure as the absolute risk difference.
The primary endpoint is a safety measure with a specific event definition and short window after an infusion. It does not capture all adverse events, all possible timing patterns, or the overall benefit-risk balance. The study also lists efficacy and pharmacokinetic outcomes, but their results are not described in the primary-outcome details used for this comparison. No conclusion about those outcomes follows from the anaphylactic-reaction result.
There were also substantial numbers of participants reported with serious adverse events, other adverse events, and deaths in both arms. These broad safety counts are separate from the primary endpoint and should be read with their own definitions and limitations. They do not by themselves identify whether an event was caused by treatment or explain differences in clinical course.
9. Statistical Methods Explained
The primary outcome is binary at the participant level: a treated participant either experienced at least one qualifying event or did not. The registry reports the percentage of participants with an event and a 95% confidence interval for each arm. A confidence interval describes the uncertainty associated with an estimate under the statistical method used; it is not a range that contains a fixed proportion of individual participants.
What does the risk difference express?
The risk difference subtracts the event percentage in one arm from the event percentage in the other. It expresses an absolute contrast, in percentage points when the risks are reported as percentages. A value of 0.0 indicates that the observed percentages were the same. It does not show that the underlying event risks must be equal: sampling uncertainty remains, as reflected by the interval from -12.3 to 12.3 percentage points in the sponsor-reported analysis.
The recalculated risk difference is a simple unadjusted comparison of the posted summary counts. It is useful as a transparent description of the observed data, but it does not replace the sponsor’s analysis. The sponsor’s analysis is the appropriate reference for the trial’s reported inferential result. The registry record does not report a discrepancy flag for this comparison.
How does an odds ratio differ?
An odds ratio compares event odds between groups rather than subtracting event percentages. An odds ratio of 1.00 indicates equal observed odds under that measure. Values above or below 1.00 represent different directions of association, but interpretation depends on which arm is in the numerator and the event definition. The sponsor-reported Cochran-Mantel-Haenszel odds ratio is 1.00, with a 95% confidence interval from 0.30 to 3.39. The method name is reported, but details such as the strata used are not reported in the registry record.
The risk difference and odds ratio answer related but distinct questions. The risk difference emphasizes absolute separation between event percentages. The odds ratio compares relative odds. Their numerical values are not directly interchangeable, and the odds ratio should not be described as a percentage-point difference.
What does a p-value contribute?
The unadjusted recalculation reports p = 1.0 for the comparison. A p-value measures how incompatible the observed data are with a specified null hypothesis under a particular statistical model; it is not the probability that the null hypothesis is true. It also does not measure clinical importance or prove that two regimens are equivalent. The registry does not report a p-value for the sponsor’s listed analyses, so the unadjusted value should not be attributed to the sponsor.
Why can an estimate be uncertain when the groups match?
Equal observed percentages can coexist with substantial uncertainty because the estimate is based on a finite number of treated participants and events. The interval for the risk difference captures a range of values that remain compatible with the data and method. An interval spanning zero is consistent with no difference, but it is also consistent with differences in either direction. A formal equivalence or non-inferiority conclusion would require prespecified margins and a design and analysis aimed at that question; such details are not reported in the registry record.
More generally, when event counts are sparse, estimates can be sensitive to small changes in the observed data, and intervals may be broad. This is a general statistical consideration, not a claim that any particular modeling problem occurred in this trial. The registry record does not report whether alternative methods for sparse binary data were considered.
How should planning calculations be understood?
The planning illustrations are based on the observed effect and stated assumptions: a two-sided significance level of 0.05, equal allocation, and a normal approximation. They describe hypothetical participants per arm for a chosen fraction of the observed effect. They are planning scenarios, not observed power, and do not establish what enrollment the original trial required. The registry record does not report the original sample-size justification or enough information to reconstruct the trial’s design assumptions.
10. Confidence Intervals and Precision
The arm-specific estimates are 11.5%, with a 95% confidence interval of 4.4% to 23.4% for each arm. The identical point estimates reflect the same observed event count, 6, among 52 treated participants in each arm. The intervals show that the underlying percentages are not estimated with high precision: values below and above the observed estimate remain compatible with the data and the reported method.
For the absolute comparison, the sponsor reported a risk difference of 0.0 percentage points, with a 95% confidence interval from -12.3 to 12.3 percentage points. The interval includes zero, as expected when the observed percentages are equal, but it also includes differences in either direction. Its width means that the data do not pinpoint a narrow range of plausible differences. The result is therefore better described as an imprecise estimate centered at no observed difference than as evidence of equivalence.
The sponsor-reported odds ratio is 1.00, with a 95% confidence interval from 0.30 to 3.39. This interval is also broad and includes values both below and above 1.00. Because the odds ratio is a relative measure and the risk difference is an absolute measure, their intervals answer different questions. Neither interval alone indicates whether any possible difference would matter clinically.
Confidence intervals depend on the analysis method and assumptions. The registry names the Cochran-Mantel-Haenszel method for the odds ratio but does not report its strata details. It does not give a method for the sponsor’s difference-in-incidence analysis. These reporting gaps limit how fully the intervals can be independently reconstructed or assessed.
11. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | DIFFERENCE IN INCIDENCE RATES 0.0 | -12.3 to 12.3 | not reported |
| Cochran-Mantel-Haenszel | Odds Ratio (OR) 1.00 | 0.30 to 3.39 | not reported |
The sponsor’s reported comparison gives a difference in incidence rates of 0.0, with a 95% confidence interval from -12.3 to 12.3. It also reports a Cochran-Mantel-Haenszel odds ratio of 1.00, with a 95% confidence interval from 0.30 to 3.39. No p-value is listed for either sponsor analysis in the registry record.
The simple unadjusted recalculation from the posted counts gives a risk difference of 0.0 and an unadjusted p-value of 1.0. The recalculated risk difference agrees with the sponsor’s reported point estimate. The registry record does not flag a discrepancy for this comparison. The recalculation is a descriptive check based on summary counts; it is not a replacement for the sponsor’s analysis, particularly where methods differ. The sponsor’s named odds-ratio method is Cochran-Mantel-Haenszel, while a recalculation from the marginal summary counts is unadjusted.
These analyses should be kept distinct. The sponsor’s confidence intervals and method describe its reported inferential analysis, while the unadjusted calculation provides a straightforward comparison of the posted group summaries. Neither analysis makes the broad confidence intervals disappear or supports an equivalence claim.
12. Multiplicity, Missing Data and Analysis Populations
The registry record lists 8 outcome measures, including this primary safety outcome and secondary outcomes covering another anaphylactic-reaction definition, grade 3-5 adverse events, objective response rate, progression-free survival, and nivolumab and ipilimumab concentrations. It reports 7 secondary outcomes as posted. Considering several outcomes creates a general multiplicity issue: when many hypotheses are tested, the chance of at least one apparently unusual result can increase unless the analysis plan addresses that issue.
The registry record does not report whether multiplicity adjustments were planned or applied, how outcomes were prioritized beyond the primary designation, or whether a hierarchy governed interpretation of the secondary results. It also does not report interim analyses or stopping rules. These details should be treated as not reported in the registry record, rather than inferred from the number of outcomes or the completed status.
The primary endpoint population is described as all treated participants. The arm records list 52 treated participants in each group, but the registry information does not explain how missing endpoint assessments, withdrawals, or incomplete follow-up were handled. It does not report an imputation method, a missing-data sensitivity analysis, or whether every randomized participant received treatment. Therefore, the precise relationship between the randomized population and the endpoint analysis population cannot be established from this record.
The registry record also does not report a detailed statistical analysis plan for the primary endpoint. The sponsor’s odds-ratio analysis names the Cochran-Mantel-Haenszel method, but strata and other implementation details are not given. The method for the sponsor’s difference-in-incidence analysis is not stated. These gaps limit assessment of prespecification, adjustment choices, and robustness. The posted results remain interpretable as reported estimates, but they cannot answer questions about unreported analysis decisions.
13. 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: Fixed Ratio Combination | 27 | 52 | 51.9% |
| Arm B: Sequential Combination | 25 | 52 | 48.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm A: Fixed Ratio Combination | 26 of 52 |
| Arm B: Sequential Combination | 29 of 52 |
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 |
|---|---|
| Arm A: Fixed Ratio Combination | 49 of 52 |
| Arm B: Sequential Combination | 48 of 52 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm A: Fixed Ratio Combination | Arm B: Sequential Combination |
|---|---|---|---|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 5 of 52 | 5 of 52 |
| Adrenocortical insufficiency acute | Endocrine disorders | 2 of 52 | 1 of 52 |
| Hypophysitis | Endocrine disorders | 0 of 52 | 3 of 52 |
| Pyrexia | General disorders | 3 of 52 | 0 of 52 |
| Hyperglycaemia | Metabolism and nutrition disorders | 3 of 52 | 0 of 52 |
| Myocarditis | Cardiac disorders | 2 of 52 | 0 of 52 |
| Hyperthyroidism | Endocrine disorders | 1 of 52 | 1 of 52 |
| Diarrhoea | Gastrointestinal disorders | 2 of 52 | 0 of 52 |
| Urinary tract infection | Infections and infestations | 0 of 52 | 2 of 52 |
| Syncope | Nervous system disorders | 1 of 52 | 1 of 52 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm A: Fixed Ratio Combination | Arm B: Sequential Combination |
|---|---|---|---|
| Fatigue | General disorders | 24 of 52 | 15 of 52 |
| Pruritus | Skin and subcutaneous tissue disorders | 15 of 52 | 15 of 52 |
| Rash | Skin and subcutaneous tissue disorders | 20 of 52 | 10 of 52 |
| Lipase increased | Investigations | 14 of 52 | 11 of 52 |
| Diarrhoea | Gastrointestinal disorders | 13 of 52 | 11 of 52 |
| Blood creatinine increased | Investigations | 10 of 52 | 11 of 52 |
| Hypothyroidism | Endocrine disorders | 12 of 52 | 8 of 52 |
| Amylase increased | Investigations | 11 of 52 | 9 of 52 |
| Cough | Respiratory, thoracic and mediastinal disorders | 12 of 52 | 5 of 52 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 8 of 52 | 8 of 52 |
Serious events with the highest arm-level rate: malignant neoplasm progression (9.6%), hypophysitis (5.8%), pyrexia (5.8%), hyperglycaemia (5.8%), myocarditis (3.8%).
The registry reports serious adverse events in 27 participants in Arm A and 25 in Arm B, with 52 at risk in each arm. Other adverse events were reported in 49 participants in Arm A and 48 in Arm B, also with 52 at risk in each arm. Deaths were reported as 26 in Arm A and 29 in Arm B. These are separate safety summaries and are not the primary endpoint counts.
The most frequent serious adverse-event terms listed are malignant neoplasm progression at 9.6%, hypophysitis at 5.8%, pyrexia at 5.8%, hyperglycaemia at 5.8%, myocarditis at 3.8%, and acute adrenocortical insufficiency at 3.8%. The registry information does not specify arm-specific percentages for these terms in the registry record used for this analysis, so they should not be assigned to an arm.
Counts of participants with adverse events do not by themselves indicate whether an event was caused by study treatment, how long it lasted, or its clinical circumstances. The death counts also do not establish cause. The registry record’s summaries should therefore be read as reported safety descriptions, not as causal comparisons or as a complete account of each participant’s outcome.
14. What the Result Does, and Does Not, Mean
The posted primary results show the same observed percentage, 11.5%, in both administration groups for the defined broad-scope anaphylactic-reaction event within 2 days after a combination-period dose. The risk-difference estimate is 0.0, and the unadjusted recalculation gives p = 1.0. This describes the observed comparison; it does not establish that the regimens have the same underlying safety profile.
The confidence intervals are central to what can be concluded. The arm-specific intervals run from 4.4% to 23.4%, while the sponsor’s risk-difference interval runs from -12.3 to 12.3 percentage points. These intervals leave room for differences in either direction. A result centered at zero is not proof of no difference, and a non-significant result is not evidence of equivalence. The registry record does not report an equivalence margin or a non-inferiority framework.
The endpoint is narrowly defined by event classification and timing. It does not summarize all adverse events, serious events, deaths, or treatment effects on cancer outcomes. The separately reported serious adverse-event and death counts should not be substituted for this primary outcome, nor should they be interpreted as treatment-caused without supporting information.
The study’s listed secondary outcomes include response, progression-free survival, and drug concentrations, but the primary-outcome information does not establish findings for those outcomes. The record also does not provide enough detail to assess all analysis choices, missing-data handling, or multiplicity procedures. The most defensible conclusion is limited: the posted summaries show equal observed percentages for this specific safety endpoint, with uncertainty broad enough that potentially relevant differences remain possible.
15. Why This Trial Matters Statistically
This comparison illustrates why an observed equality is not the same as a precise estimate. Both arms had the same reported percentage for the primary event, yet the sponsor’s confidence interval for the risk difference spans values favoring either regimen. Reading only the point estimate would understate the uncertainty; reading the interval makes the limits of the evidence clearer.
It also demonstrates the value of distinguishing absolute and relative measures. The risk difference conveys the separation in event percentages, while the odds ratio compares event odds. They answer related but different questions and have different interpretations. Reporting both can help readers understand the result, but the methods behind each measure must remain clear, especially when one analysis is adjusted or stratified and another is an unadjusted recalculation.
The endpoint definition matters as well. This outcome is tied to a particular MedDRA query scope and a short window after an infusion during the combination period. A result for that outcome cannot be generalized automatically to all safety events, to a different query scope, or to the broader clinical course. The registry’s separately listed secondary outcomes underline that efficacy and pharmacokinetic questions are distinct from the primary safety comparison.
Finally, the registry record illustrates how limitations in reporting affect interpretation. The primary population is identified, and the main estimates are available, but details about missing data, multiplicity, and elements of the analysis plan are not reported. Statistical interpretation depends not just on an estimate, but also on its uncertainty, endpoint definition, analysis method, and the information available about how the result was produced.
16. 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.
- Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.
The primary endpoint is a specific safety outcome rather than a comprehensive measure of toxicity. It counts participants with at least one event in the broad-scope MedDRA Anaphylactic Reaction SMQ within the defined interval after an infusion. The result does not describe event duration, recurrence, severity, or individual clinical circumstances. The registry record does not report further details about event adjudication or the query’s implementation.
The trial is described as phase 2 and randomized, but the registry record does not report the sample-size justification, assumptions about the expected event frequency, or a prespecified clinically important difference. The confidence intervals are broad, and no equivalence or non-inferiority margin is reported. Equal observed percentages therefore cannot establish that the regimens are interchangeable for this safety outcome.
The record does not report how missing assessments or incomplete follow-up were handled, nor does it provide a detailed account of the relation between all randomized participants and the treated primary-outcome population. It also does not report whether multiplicity adjustments, interim analyses, or sensitivity analyses were used. These omissions limit evaluation of how robust the inference is to analysis choices.
The sponsor’s odds-ratio method is identified as Cochran-Mantel-Haenszel, but its strata are not described. The method for the sponsor’s difference analysis is not reported. A simple recalculation from summary counts cannot recover these unreported details and should not be treated as a substitute for the sponsor’s own analysis.
Finally, safety summaries such as serious adverse events and deaths do not establish causation, and the primary endpoint does not address cancer response or progression. The listed secondary outcomes are separate questions; their results and methods are not detailed in the registry record used for this interpretation.
17. Related Tutorials
18. Related Statistical Calculators
19. Sources
- ClinicalTrials.gov: An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma — NCT03029780.
- Registry record last updated 2022-06-29; status last verified 2022-06.
- Results first posted 2018-12-19.
- 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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20. Record Summary
The registry record describes a completed, randomized, parallel, unmasked phase 2 study of nivolumab plus ipilimumab in renal cell carcinoma. It compared fixed-ratio co-administration with sequential administration. Enrollment was 104, and the primary-outcome records list 52 treated participants in each arm.
The primary endpoint was the percentage with a broad-scope MedDRA Anaphylactic Reaction SMQ event within 2 days after a combination-period dose. The reported percentage was 11.5% in each arm, with a 95% confidence interval of 4.4% to 23.4% for each. The sponsor’s risk-difference estimate was 0.0, with a 95% confidence interval from -12.3 to 12.3. The results show equal observed percentages but do not establish equivalence, and the interval leaves uncertainty about the underlying difference.