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 Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer (NCT03172624), a non-randomized phase 2 study. The primary outcome is Best Overall Response Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03172624 |
| Phase | Phase 2 |
| Condition | Salivary Gland Cancer |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 64 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
People enrolled with recurrent or metastatic salivary gland cancer, divided into an adenoid cystic carcinoma group and a group with salivary gland cancer of any histology except adenoid cystic carcinoma. The registry record lists an enrollment of 64. Further eligibility details and characteristics of the enrolled population are not reported in the registry record.
Intervention
The regimen combines nivolumab and ipilimumab. In both groups, the record describes nivolumab 3 mg/kg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks, with 1 cycle= 6 weeks.
Comparator
No separate control treatment is described. The study is non-randomized, and the two groups are organized by cancer histology rather than assigned to competing treatments. They therefore are not like-for-like control groups for estimating a treatment contrast.
Primary question
The primary endpoint is Best Overall Response Rate, assessed using the revised Response Evaluation Criteria in Solid Tumors guideline, version 1.1, over a timeframe of 2 years. The endpoint concerns the number of participants meeting the response criterion. The number meeting it, the corresponding rate, and an uncertainty estimate are not reported in the registry record.
3. Trial Design
NCT03172624 is listed as a phase II study sponsored by Memorial Sloan Kettering Cancer Center. Its official title describes nivolumab plus ipilimumab in patients with recurrent or metastatic salivary cancers. The registry lists the study as completed, with enrollment of 64. The recorded start date is 2017-05-26, and the primary completion date is 2024-12-18.
The design is non-randomized, unmasked, and parallel. Participants were grouped according to histology: recurrent or metastatic adenoid cystic carcinoma (ACC), and recurrent or metastatic salivary gland cancer of any histology except ACC (Non ACC). Both group descriptions specify the same nivolumab and ipilimumab regimen. The registry does not describe a separate comparator regimen or a random allocation process.
Because the groups differ by histology and participants were not randomized between treatments, a comparison between their outcomes would not isolate a treatment effect. Differences could reflect the group definitions or other factors; details needed to assess such factors are not reported in the registry record. The groups are best understood as distinct cohorts receiving the same combination, not as treatment and control arms in a randomized comparison.
The primary outcome is Best Overall Response Rate, with a 2 years timeframe and response determined using the revised RECIST guideline, version 1.1. The registry lists one outcome measure and no analyses. It does not report a primary endpoint result, analysis population, statistical analysis plan, or confidence interval. The study’s sample-size justification and any planned interim analyses are not reported in the registry record.
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 | R/M Adenoid Cystic Carcinoma (ACC) | R/M SGC of Any Histology, Except ACC (Non ACC) |
|---|---|---|
| STARTED | 32 | 32 |
| COMPLETED | 32 | 32 |
| 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 | R/M Adenoid Cystic Carcinoma (ACC) | R/M SGC of Any Histology, Except ACC (Non ACC) | Total |
|---|---|---|---|---|
| Participants analysed | 32 | 32 | 64 | |
| Age, Continuous | years | 58 (30 to 88) | 64 (57 to 88) | 64 (30 to 88) |
| Sex: Female, Male: Female | Participants | 19 | 12 | 31 |
| Sex: Female, Male: Male | Participants | 13 | 20 | 33 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 0 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 30 | 29 | 59 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 3 | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 28 | 26 | 54 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 4 | 5 |
| Region of Enrollment: United States | Participants | 32 | 32 | 64 |
6. Primary Endpoint
The registry lists the primary outcome as Best Overall Response Rate, measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
Best Overall Response Rate is a binary participant-level endpoint: each participant either meets the response definition or does not. The registry describes the measure as a count of participants and specifies use of the revised Response Evaluation Criteria in Solid Tumors guideline, version 1.1. The assessment timeframe is 2 years. The registry does not give additional operational details about assessment timing, confirmation requirements, or how missing assessments were handled.
In general, a response endpoint is used to describe whether participants meet prespecified tumor-response criteria during the assessment period. Counting participants who meet the criteria can provide a direct summary of observed response in a study cohort. To interpret a response rate, however, readers need the number meeting the criteria, the relevant denominator, and an indication of uncertainty. Those results are not reported in the registry record, so the endpoint’s observed value and precision cannot be assessed from this record.
The endpoint does not by itself establish a comparative treatment effect. In this study, the two cohorts are not randomized treatment groups and both receive the combination. Without an appropriate comparator and a reported analysis, the primary endpoint can only be interpreted as a planned measure of response in the enrolled groups, not as evidence of a causal difference between treatments.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically relevant descriptive question: how many participants with recurrent or metastatic salivary cancer meet the specified response criteria during the 2 years assessment timeframe while receiving nivolumab plus ipilimumab. It does not post the primary endpoint result. There is therefore no response count, rate, confidence interval, or primary endpoint test to interpret from the registry record.
The record lists one outcome measure and no analyses. This does not establish that no analyses were conducted; it means an analysis result is not reported in the registry record. The posted safety information includes counts of participants affected by serious adverse events, other adverse events, and deaths in each histology group, along with selected serious adverse event terms. Those figures describe recorded events and do not supply the missing primary response result.
The study’s non-randomized structure is important when considering any comparison between its two groups. They are defined by histology, not by competing randomized treatments. Consequently, a difference between group summaries would not demonstrate that the combination caused a difference. The record also does not provide adjusted comparisons or information that would establish comparability between the cohorts.
General statistical interpretation: an estimate is more informative when presented with an uncertainty interval, because the interval shows the range of values reasonably compatible with the observed data under the stated method. No primary endpoint interval is reported. Without the numerator, denominator, and uncertainty estimate, readers cannot judge how precisely the response outcome was measured or whether the observed result is compatible with a wide range of underlying response probabilities.
The completion status and enrollment count describe the study record, not the magnitude or certainty of an endpoint result. Similarly, a planning illustration based on an observed effect is not an observed-power calculation and cannot substitute for a reported endpoint analysis. The registry record does not report the observed effect for the primary endpoint, the protocol’s sample-size justification, or a statistical analysis plan. The central interpretation is therefore limited: the trial design and endpoint are described, but the posted record does not give the primary outcome result needed to quantify response.
9. Statistical Methods Explained
What kind of endpoint is being measured?
The registry classifies the primary outcome as a count of participants and describes it as Best Overall Response Rate. In statistical terms, response status is binary at the participant level: a person either meets the stated response criteria or does not. A count alone is not a rate; a rate also needs a denominator. The registry record does not report either the number meeting the criteria or the denominator used for an endpoint analysis.
The response criteria are identified as the revised Response Evaluation Criteria in Solid Tumors guideline, version 1.1, and the timeframe is 2 years. The record does not provide further details about how response assessments were scheduled, whether responses needed confirmation, or what rules were used when assessments were unavailable. These details can matter because endpoint classification depends on the assessment process as well as the criteria.
How should uncertainty be understood?
General explanation: an estimate from a finite group of participants is subject to sampling variability. A confidence interval conveys uncertainty around an estimate under a specified statistical method. A narrower interval generally indicates greater precision; a wider interval indicates that the data are compatible with a broader range of values. An interval does not resolve bias from study design or measurement, and it does not turn an association into a causal effect.
No response estimate or confidence interval is reported in the registry record. The size of the enrolled study alone cannot establish the precision of the primary outcome. Precision depends on the actual endpoint data and the analysis method, neither of which is posted for the primary endpoint.
What does the study design permit?
The study is non-randomized and has parallel histology groups. Both group descriptions specify nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks, with 1 cycle= 6 weeks. As the groups are formed by cancer histology rather than randomized assignment, a comparison between them is not a randomized treatment comparison. General explanation: randomization is one way to balance prognostic factors across treatment groups on average. Without it, group differences may reflect factors other than treatment. The registry does not report an adjusted analysis that could address such differences.
The absence of masking is recorded as none. The record does not give further information about who assessed response or whether assessment procedures included safeguards against assessment bias. Those details are not reported in the registry record.
What do the planning assumptions mean?
The record describes a sample-size planning illustration based on an observed effect, not the trial’s own design. Its stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Any sample-size values based on these assumptions are planning illustrations, not observed power, and they do not show that the study was designed with those assumptions. The protocol’s sample-size justification is not reported in the registry record.
General explanation: a significance level is a threshold used in a specified testing procedure, while a normal approximation is a mathematical method for estimating or testing quantities. Their use in a planning illustration does not mean those methods were the trial’s prespecified analysis. The record lists no analyses, and the statistical analysis plan is not reported in the registry record. No recalculated primary endpoint analysis can be interpreted without the observed response data and the sponsor’s analysis.
Why does over-dispersion matter in general?
General explanation: over-dispersion occurs when observed variability is greater than a model assumes. If a model underestimates variability, standard errors may be too small and uncertainty intervals may be too narrow. Whether over-dispersion is relevant depends on the endpoint and the statistical model. The registry record does not identify a model for the primary endpoint, so there is no basis to determine whether an over-dispersion adjustment was planned or used.
For a binary participant outcome, interpretation ordinarily depends on the response count, denominator, and method used to estimate uncertainty. These are not reported for the primary outcome. The posted record therefore supports description of the endpoint and design, but not reconstruction of the primary statistical result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure and no analyses. It does not describe a statistical analysis plan, a hierarchy of endpoints, adjustment for multiple testing, or rules for choosing among analyses. Multiplicity handling is therefore not reported in the registry record. The listing of one outcome does not establish whether other analyses were planned or conducted.
The record also does not report the analysis population for the primary endpoint. It does not specify whether participants were analyzed according to enrollment, treatment received, availability of response assessments, or another rule. The record gives no details about exclusions from the endpoint analysis or the handling of participants who did not complete assessments.
Missing-data methods are not reported in the registry record. For a binary response endpoint, missing assessments can affect classification and the denominator; general methods may treat missing outcomes differently, so the chosen rule matters to interpretation. No method can be assumed from the endpoint name or study status.
Because no primary response count, rate, or uncertainty estimate is posted, readers cannot assess how missing information or multiplicity might influence the endpoint result. These omissions limit reproducibility and make it impossible to connect any planning assumptions to a reported primary analysis.
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 |
|---|---|---|---|
| R/M Adenoid Cystic Carcinoma (ACC) | 18 | 32 | 56.2% |
| R/M SGC of Any Histology, Except ACC (Non ACC) | 9 | 32 | 28.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| R/M Adenoid Cystic Carcinoma (ACC) | 6 of 32 |
| R/M SGC of Any Histology, Except ACC (Non ACC) | 7 of 32 |
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 |
|---|---|
| R/M Adenoid Cystic Carcinoma (ACC) | 11 of 32 |
| R/M SGC of Any Histology, Except ACC (Non ACC) | 14 of 32 |
Most frequent serious adverse event terms
| Event term | Organ system | R/M Adenoid Cystic Carcinoma (ACC) | R/M SGC of Any Histology, Except ACC (Non ACC) |
|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 6 of 32 | 1 of 32 |
| Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 of 32 | 1 of 32 |
| Aspartate aminotransferase increased | Investigations | 2 of 32 | 1 of 32 |
| Diarrhea | Gastrointestinal disorders | 2 of 32 | 1 of 32 |
| Fatigue | General disorders | 2 of 32 | 1 of 32 |
| Anemia | Blood and lymphatic system disorders | 1 of 32 | 1 of 32 |
| Hyponatremia | Metabolism and nutrition disorders | 1 of 32 | 1 of 32 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 1 of 32 | 1 of 32 |
| Non-cardiac chest pain | General disorders | 2 of 32 | 0 of 32 |
| Pain | General disorders | 2 of 32 | 0 of 32 |
Most frequent non-serious adverse event terms
| Event term | Organ system | R/M Adenoid Cystic Carcinoma (ACC) | R/M SGC of Any Histology, Except ACC (Non ACC) |
|---|---|---|---|
| Lymphocyte count decreased | Investigations | 11 of 32 | 14 of 32 |
| Hyponatremia | Metabolism and nutrition disorders | 4 of 32 | 5 of 32 |
| Aspartate aminotransferase increased | Investigations | 4 of 32 | 2 of 32 |
| Anemia | Blood and lymphatic system disorders | 4 of 32 | 1 of 32 |
| Neutrophil count decreased | Investigations | 2 of 32 | 3 of 32 |
| Hyperglycemia | Metabolism and nutrition disorders | 0 of 32 | 4 of 32 |
| Hypophosphatemia | Metabolism and nutrition disorders | 2 of 32 | 2 of 32 |
| White blood cell decreased | Investigations | 1 of 32 | 3 of 32 |
| Alanine aminotransferase increased | Investigations | 2 of 32 | 0 of 32 |
Serious events with the highest arm-level rate: dyspnea (18.8%), neoplasms ben/mal/unk (inc cyst/polyp) other, spec (9.4%), aspartate aminotransferase increased (6.2%), diarrhea (6.2%), fatigue (6.2%).
The registry reports serious adverse event counts by histology group. In the ACC group, 32 participants were at risk and 18 were affected; in the Non ACC group, 32 were at risk and 9 were affected. For other adverse events, the corresponding counts are 11 of 32 in the ACC group and 14 of 32 in the Non ACC group. Deaths are listed as 6 and 7, respectively. These are counts within the stated groups, not a randomized comparison of treatment strategies.
The registry also lists Dyspnea at 18.8% among the top serious adverse event terms. Other listed terms are Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec at 9.4%, and Aspartate aminotransferase increased, Diarrhea, Fatigue, and Non-cardiac chest pain, each at 6.2%. The record does not state in these entries whether an event was judged related to treatment, nor does it provide further context for interpreting the terms.
General explanation: an adverse event recorded during a study is not necessarily caused by the study treatment. Serious adverse event counts describe events meeting serious-event reporting criteria, but the label alone does not establish causality. The registry figures should be read as descriptive safety data; they do not establish comparative risks between the histology groups.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II, non-randomized study evaluated a combination of nivolumab and ipilimumab in recurrent or metastatic salivary cancers, with separate histology groups. It identifies Best Overall Response Rate as the primary outcome, assessed over 2 years using the revised RECIST guideline, version 1.1. The study is listed as completed with enrollment of 64.
The record does not report the primary response count, response rate, confidence interval, or analysis. It therefore does not quantify the observed response or its precision. The absence of a posted result should not be interpreted as a result in either direction. It means that the registry record does not supply the primary endpoint information needed to evaluate the outcome statistically.
The two groups do not function as randomized treatment and control arms. Both are described as receiving the same combination, and their distinction is histology. A contrast between group outcomes, even if one were posted, would not by itself estimate the causal effect of treatment. The record does not report an adjusted analysis or other information that would support a causal interpretation.
General explanation: statistical estimates describe the observed data under specified analysis assumptions. Their precision and validity depend on data completeness, measurement, and design. A response count without an appropriate denominator would not establish a rate; a rate without an uncertainty estimate would provide limited information about precision. None of these primary endpoint quantities is reported in the registry record.
The safety counts describe recorded adverse events and deaths in the two cohorts, but do not establish that treatment caused those events or permit a randomized comparison. Thus, the posted record describes the study question, treatment regimen, design, and selected safety summaries, while leaving the primary efficacy result and its statistical uncertainty unreported.
13. Why This Trial Matters Statistically
This study illustrates why a clearly named endpoint is not enough to support a statistical conclusion. The registry identifies Best Overall Response Rate, its assessment criteria, and a 2 years timeframe, but does not report the response count, denominator, rate, or uncertainty. Without those elements, the main outcome cannot be evaluated for magnitude or precision.
It also illustrates the distinction between parallel cohorts and randomized comparison groups. Although the study has two histology groups, they are not assigned to competing treatments. Both groups receive the described combination. The group structure can support descriptive reporting by histology, but it does not by itself create a control condition for estimating a treatment effect.
The record’s safety summaries and completed status provide useful context about what was registered, but they do not replace the primary endpoint analysis. Likewise, a planning illustration is not an observed result and cannot show how precisely the trial estimated its outcome. The protocol’s sample-size justification and analysis plan are not reported in the registry record.
For clinical researchers and statisticians, the central lesson is to separate design, outcome definition, observed data, and inference. The design identifies the limits on comparisons; the endpoint definition specifies what was meant to be measured; the posted result would quantify what was observed; and an uncertainty estimate would show precision under a stated method. In this record, the first two are described, while the primary result and its inferential details are not reported.
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 principal limitation for statistical interpretation is that the primary endpoint result is not reported in the registry record. There is no response count, rate, denominator, confidence interval, or analysis to assess. The record also lists no analyses, so the primary outcome cannot be independently interpreted from the posted information.
The non-randomized design limits treatment comparisons. The two cohorts are distinguished by histology and both receive nivolumab plus ipilimumab; neither serves as a randomized control group. The registry does not report adjusted comparisons or sufficient information to assess whether the groups are comparable on other characteristics.
Important analytic details are not reported in the registry record, including the analysis population, missing-data rules, response assessment schedule, sample-size justification, and statistical analysis plan. The record does not describe interim analyses or multiplicity procedures. These gaps limit assessment of how the endpoint would be analyzed and how robust any result might be to alternative analytic choices.
The safety counts are descriptive and do not establish causality. The registry entries do not provide further attribution details for the adverse events, and the figures do not form a randomized treatment comparison. These limitations do not change what the record reports, but they constrain the conclusions that can be drawn from it.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer — NCT03172624.
- Registry record last updated 2025-12-18; status last verified 2024-12.
- Results first posted 2025-12-18.
- 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
NCT03172624 is a completed phase II, non-randomized, unmasked, parallel study sponsored by Memorial Sloan Kettering Cancer Center. It enrolled 64 participants with recurrent or metastatic salivary cancers, separated into ACC and Non ACC groups. Both group descriptions specify nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks.
The primary outcome is Best Overall Response Rate over 2 years, assessed using the revised RECIST guideline, version 1.1. The registry record does not report the primary endpoint result or an analysis. It lists adverse event counts by group and selected serious adverse event terms. The two histology cohorts are not randomized treatment and control groups, so their safety or outcome counts should not be read as a like-for-like treatment comparison.