This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Phase I/II Trial to Evaluate a Peptide Vaccine Plus Ipilimumab in Patients With Melanoma (NCT02385669), a na phase 1, phase 2 study. The primary outcome is Safety (Adverse Event Profile).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02385669 |
| Phase | Phase 1, Phase 2 |
| Condition | Melanoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Craig L Slingluff, Jr |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned patients with melanoma. The primary outcome description identifies the population as eligible enrolled and treated patients. The registry record reports enrollment of 3; it does not give further participant characteristics in the information available for this analysis.
Intervention
The study evaluated 6MHP, a helper peptide vaccine, in combination with ipilimumab. The vaccine product is described as containing 6 class II MHC-restricted peptides derived from melanoma proteins, with 200 mcg of each peptide in each vaccine. The vaccine was mixed with Montanide ISA-51. The recorded description of administration is incomplete, so a full schedule is not reported in the registry record.
Comparator
There was no comparator arm: the registry describes a single-group study and gives allocation as NA. The posted safety counts therefore describe participants receiving the combination; they are not a randomized comparison with another treatment or with a control group.
Primary question
The primary endpoint asks about the safety profile of 6MHP plus ipilimumab, using adverse events and dose-limiting toxicities among eligible enrolled and treated patients. The specified observation timeframe is 30 days after the last vaccination. The study also set out to assess effects on the immune system, using laboratory tests on blood, a lymph node, and tumor samples. A secondary outcome concerns epitope spreading for CD8+ T cells in blood and the sentinel immunized node.
3. Trial Design
The registry classifies NCT02385669 as a Phase I/II trial with a single-group model. Allocation is listed as NA, and masking as NONE. With no control group, its posted results are descriptive: they report events among participants who received the combination, rather than estimating a treatment contrast between groups. The registry lists 3 enrolled participants and marks the study as terminated.
The intervention is the combination of ipilimumab and 6MHP. The vaccine is described as a product containing 6 melanoma-derived, class II MHC-restricted peptides, with 200 mcg of each peptide per vaccine. The vaccine solution is mixed with Montanide ISA-51 to form a water-in-oil emulsion. The registry's arm description ends before the administration schedule is complete; the full schedule is not reported in the registry record.
The primary outcome is an adverse-event profile, including adverse events and dose-limiting toxicities. Its stated timeframe is 30 days after the last vaccination, and its population is all eligible enrolled and treated patients. The registry also names an immune-response outcome concerning epitope spreading for CD8+ T cells. It states that the investigators would assess immune effects with laboratory tests on blood, a lymph node, and tumor samples.
The record lists 3 outcome measures but no analyses. It does not report a randomized design, a concurrent comparator, or masking. Those design features matter when interpreting what the observed counts can establish: a single-group safety profile can describe reported events in the treated group, but it cannot by itself distinguish events related to treatment from events that might otherwise occur. Details of the protocol beyond the recorded descriptions 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 | 6MHP and Ipilimumab |
|---|---|
| STARTED | 3 |
| COMPLETED | 1 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | 6MHP and Ipilimumab |
|---|---|
| Adverse Event | 2 |
Analysis population for the primary outcome, as defined in the registry: All eligible enrolled and treated patients. Partiipants analyzed for any adverse event (AE) and for dose limiting toxicities (DLT).
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 | 6MHP and Ipilimumab |
|---|---|---|
| Participants analysed | 3 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 |
| Age, Categorical: >=65 years | Participants | 1 |
| Age, Continuous | years | 54 (45 to 79) |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 2 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Safety (Adverse Event Profile), measured over 30 days after the last vaccination.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is Safety (Adverse Event Profile), measured as counts of participants. It concerns adverse events and dose-limiting toxicities in eligible enrolled and treated patients receiving 6MHP with ipilimumab. The stated timeframe is 30 days after the last vaccination. The posted results give participant counts for serious and other adverse events, along with a serious adverse-event term.
In general, a safety endpoint is used to characterize what adverse events are observed during a defined observation period. Counts of participants with events are directly interpretable as descriptions of the study group, but they do not alone establish why an event occurred. The endpoint description does not provide a grading system, a severity threshold for dose-limiting toxicity, or detailed rules for assigning events to categories; these details are not reported in the registry record.
The endpoint is not a measure of comparative benefit. Because this is a single-group study, the safety counts have no concurrent control group for comparison. The posted results therefore describe the recorded event experience in this group, not a causal difference between the combination and another treatment. The endpoint's limited follow-up window also means it concerns the specified period after the last vaccination; other follow-up periods are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted results report that 1 of 3 participants had a serious adverse event, while 3 of 3 had other adverse events. The serious adverse-event term listed most prominently is uveitis, reported as 33.3%. The record reports 0 deaths. These are descriptive counts from the combination group, not estimates from a controlled comparison.
The denominator is important. With 3 participants, each participant represents a substantial part of the observed group. A count can therefore change noticeably with the event status of a single participant, and the posted percentages and counts should not be read as precise estimates of how often events would occur in a broader population. In general, uncertainty intervals can communicate how imprecise an estimate is; the registry record does not report confidence intervals for these safety counts.
The record does not explain whether the serious and other adverse-event categories are mutually exclusive, how events were graded, or whether participants could contribute to multiple event terms. The serious adverse-event count and the count for other adverse events should thus be read as the categories in which the registry presents them, without assuming that they form a partition or can be combined. The reported uveitis percentage is attached to the serious adverse-event term; it should not be interpreted as a comparative risk estimate.
No inferential analyses are recorded. The data therefore do not include a reported hypothesis test, adjusted estimate, or formal comparison. In a single-group study, even a statistical test against a hypothetical benchmark would require a benchmark and analysis plan; neither is reported in the registry record. The counts alone do not establish that the combination caused any particular event or that the absence of deaths implies an absence of safety concerns.
The study's stated purpose also included assessing immune effects through laboratory testing, and a secondary outcome addressed epitope spreading for CD8+ T cells. The safety counts do not answer those immune-response questions. Numerical results for those outcomes are not reported in the registry record. Overall, the available safety information is a small-group description within a defined follow-up window, with no comparative or inferential result reported.
9. Statistical Methods Explained
The registry reports a binary participant-level safety outcome: whether participants experienced adverse events, including dose-limiting toxicities. For this kind of endpoint, counts describe how many participants in the analyzed group experienced an event. The posted safety data give counts for serious and other adverse events, as well as a listed serious adverse-event term. They do not report an inferential analysis or a confidence interval.
What does a participant count mean?
A participant count is a direct summary of observed event status in the recorded group. It answers a descriptive question: how many participants were recorded as having the event category? It does not, by itself, estimate a causal effect. In general, causal interpretation requires a design and assumptions that address what would have happened to comparable participants under another condition. This trial is listed as single-group, without a comparator arm, so its event counts do not provide that contrast.
The count is also tied to how the event is defined and collected. Details such as severity grading, event attribution, coding rules, and whether recurring events are counted once or repeatedly can affect interpretation. The registry identifies an adverse-event profile and dose-limiting toxicities as the primary safety focus, but those operational definitions are not reported in the registry record.
How should uncertainty be understood?
In general, a confidence interval expresses the range of values compatible with the observed data under a specified statistical method and assumptions. It helps distinguish a precise estimate from one that remains highly uncertain. For a binary outcome, an interval may be constructed around the observed proportion using a method appropriate to the sample size and analysis plan. No interval method or confidence interval is reported for the posted safety results, so no interval should be inferred from the counts.
With a small group, the uncertainty around an event frequency is typically substantial. This is a general statistical point, not an additional estimate for this trial. A count observed in a small study can describe what happened among its participants, while still being a weak guide to the frequency in a larger or different population. A lack of a reported event in a small group would not establish that the event cannot occur.
Why does the study design matter?
In a randomized comparative trial, groups can be compared using an effect measure chosen in advance, with uncertainty quantified under a prespecified analysis. Here, there is one treatment group. The registry lists allocation as NA and masking as NONE. The posted data therefore support a description of events in the treated group but not an estimate of the difference between treatment conditions. There is no control-group event rate in the record against which to interpret the counts.
Blinding can matter in safety assessment because awareness of treatment may influence reporting or assessment of some events. The registry records no masking. This alone does not show that event reporting was biased, but it is relevant context when considering how outcomes were ascertained. Information on independent review or blinded event adjudication is not reported in the registry record.
What is the role of sample-size planning?
In general, sample-size planning uses a target effect, variability or event-rate assumptions, a significance level, and a desired power to estimate how much information a study might need. Such calculations are planning illustrations, not observed evidence and not a measure of the power achieved after a study is completed. The registry record does not report the trial's sample-size justification or the assumptions used for its design. Numerical planning results are not reported in the registry record.
The record lists no analyses. It consequently does not identify a statistical model, a method for handling repeated or multiple events, an approach to missing data, or an adjustment for multiple outcomes. These omissions mean that the posted counts can be read descriptively, but there is no reported analysis plan with which to assess model-based claims. General statistical methods can explain how safety data might be analyzed, but they should not be mistaken for methods used in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures and identifies safety as the primary endpoint. It also names epitope spreading for CD8+ T cells in blood and the sentinel immunized node as a secondary outcome. The record lists no analyses, so it does not report how outcomes were prioritized in statistical testing, whether any multiplicity adjustment was planned, or how results across outcomes would be interpreted together. A multiplicity strategy is not reported in the registry record.
In general, testing multiple outcomes can increase the chance of at least one apparently unusual result when each is considered separately. A prespecified hierarchy or adjustment can address that issue, but no such approach is reported. The presence of multiple outcomes does not establish that formal hypothesis tests were performed; the registry records no analyses.
The primary outcome population is described as all eligible enrolled and treated patients. That defines the stated population for the safety assessment, but it does not specify how participants who were eligible or enrolled but not treated would be handled, or how missing event information would be addressed. Rules for missing data, exclusions, and analysis populations beyond the stated description are not reported in the registry record.
For safety outcomes, missingness can affect interpretation if an event was not assessed or recorded for a participant. In general, transparent reporting describes the amount and reasons for missing data and the methods used to handle them. Those details are not reported in the registry record. The posted counts should therefore be understood as the registry's recorded results, without assuming additional participants, imputations, or sensitivity analyses.
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 |
|---|---|---|---|
| 6MHP and Ipilimumab | 1 | 3 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 6MHP and Ipilimumab | 0 of 3 |
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 |
|---|---|
| 6MHP and Ipilimumab | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | 6MHP and Ipilimumab |
|---|---|---|
| uveitis | Eye disorders | 1 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 6MHP and Ipilimumab |
|---|---|---|
| skin induration | Skin and subcutaneous tissue disorders | 3 of 3 |
| Nausea | Gastrointestinal disorders | 2 of 3 |
| Vomiting | Gastrointestinal disorders | 2 of 3 |
| Fatigue | General disorders | 2 of 3 |
| Injection site reaction | General disorders | 2 of 3 |
| Pruritis | Skin and subcutaneous tissue disorders | 2 of 3 |
| skin hypopigmentation | Skin and subcutaneous tissue disorders | 2 of 3 |
| adrenal insufficiency | Endocrine disorders | 1 of 3 |
| blurred vision | Eye disorders | 1 of 3 |
| Other | Eye disorders | 1 of 3 |
Serious events with the highest arm-level rate: uveitis (33.3%).
The safety results report 1 of 3 participants with a serious adverse event and 3 of 3 with other adverse events. The most prominent serious adverse-event term is uveitis, reported as 33.3%. The record reports 0 deaths. These figures describe the group receiving 6MHP and ipilimumab; they are not a comparison with an untreated group or another treatment.
In general, a serious adverse event is a category distinct from an event's specific medical term, but the registry's detailed classification rules are not reported. The record also does not say whether serious and other event categories overlap, whether participants experienced multiple events, or how severity and attribution were assessed. The listed percentage for uveitis should therefore be read as the registry's reported figure for that term, not as evidence about comparative risk or causation.
The small group makes the counts sensitive to each participant's event status. The absence of reported deaths does not establish that the combination has no safety risks, and the counts do not establish that treatment caused any event. The primary endpoint's stated observation period is 30 days after the last vaccination; safety beyond that timeframe is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The result supports a narrow descriptive statement: the registry records serious and other adverse events among participants treated with 6MHP plus ipilimumab, with a specified safety timeframe of 30 days after the last vaccination. It also records uveitis as the most prominent serious adverse-event term and reports 0 deaths. Those observations are relevant to the stated safety objective, but they are not a complete characterization of safety beyond the recorded outcomes and follow-up.
The result does not establish whether the combination caused an event. Without a comparator group, there is no concurrent estimate of event frequency under another condition. It also does not show whether the observed counts differ from a prespecified threshold, because a threshold and inferential analysis are not reported in the registry record. No confidence intervals or hypothesis tests are reported.
The small enrolled group limits precision and generalizability. Counts from this group may not represent event frequencies among other patients with melanoma or in other settings. The record does not provide participant characteristics that would allow readers to assess how closely the enrolled patients resemble a broader population. It also does not provide detailed event definitions, ascertainment procedures, or missing-data handling.
The study's immune-system aims are separate from the safety counts. The registry describes laboratory assessment using blood, a lymph node, and tumor samples, and lists epitope spreading for CD8+ T cells as a secondary outcome. Numerical findings for these immune outcomes are not reported in the registry record, so the safety results do not answer whether such immune changes were observed.
In general, a small early-phase study can provide descriptive information and inform questions for further study, but the record does not report a design-based estimate of comparative benefit or harm. The posted results should be read as observations in this group, not as a conclusion about treatment effectiveness or the expected experience of patients outside the study.
13. Why This Trial Matters Statistically
This trial is statistically notable for the gap between the breadth of its aims and the limited information available for quantitative interpretation. It is a Phase I/II study designed to assess safety and immunogenicity, but the registry results available for this analysis consist of safety counts in a single group. The record lists 3 enrolled participants and no analyses.
Small-group safety data are useful as descriptions of what was recorded, but they offer limited precision. With only a few observations, the event status of an individual participant has substantial influence on the group summary. In general, uncertainty intervals and careful event definitions help readers understand the limits of such estimates; neither intervals nor detailed classification rules are reported in the registry record.
The lack of a comparator is also central. Counts from a single group cannot be interpreted as a relative effect against another treatment or against no treatment. This is not a flaw in every descriptive safety objective: a single-group study can still record events. It does, however, set a clear boundary on the claims that the posted data can support.
The registry also shows why outcome reporting matters. Safety is identified as the primary endpoint, and an immune outcome is named, but the record does not include inferential analyses or numerical immune-response results. Without those details, readers cannot assess estimates, uncertainty, multiplicity handling, or the relationship between the stated immune aims and the posted safety counts.
The most defensible statistical reading is therefore deliberately restrained: these data document adverse-event counts in the recorded treatment group and a defined follow-up period. They do not establish comparative effects, provide precise population event rates, or resolve the study's immune-response questions.
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 is the small enrolled group: the registry reports 3 participants. This restricts precision and makes the descriptive counts highly sensitive to individual observations. The record does not report confidence intervals or other uncertainty estimates for the safety results.
The single-group design has no concurrent control arm, and allocation is listed as NA. Consequently, the posted safety counts cannot estimate a difference between treatment conditions. Masking is listed as NONE; details of event assessment, independent review, or attribution are not reported in the registry record.
The registry states that the primary endpoint concerns adverse events and dose-limiting toxicities in eligible enrolled and treated patients, with assessment through 30 days after the last vaccination. It does not report detailed definitions, severity grading, event-coding rules, or how repeat events and overlapping categories were handled. The complete vaccination schedule is also not reported in the registry record.
The record lists 3 outcome measures but no analyses. It does not report the statistical analysis plan, sample-size justification, multiplicity approach, missing-data methods, or sensitivity analyses. Participant characteristics and numerical results for the stated immune-response outcomes are not reported in the registry record. These gaps limit assessment of generalizability and prevent a fuller quantitative interpretation of the study's stated objectives.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase I/II Trial to Evaluate a Peptide Vaccine Plus Ipilimumab in Patients With Melanoma — NCT02385669.
- Registry record last updated 2020-05-05; status last verified 2020-04.
- Results first posted 2019-06-26.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02385669 is a terminated Phase I/II, single-group study of 6MHP plus ipilimumab in patients with melanoma. The registry reports enrollment of 3 participants, no masking, and no comparator arm. The primary endpoint is a safety profile covering adverse events and dose-limiting toxicities through 30 days after the last vaccination.
The posted results report 1 of 3 participants with a serious adverse event, 3 of 3 with other adverse events, uveitis at 33.3% as the most prominent serious adverse-event term, and 0 deaths. The registry lists 3 outcome measures and no analyses. Numerical immune-response results, confidence intervals, a comparator-based estimate, and detailed analysis methods are not reported in the registry record.