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-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer (NCT03695250), a na phase 1, phase 2 study. The primary outcome is Adverse Events (AE).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03695250 |
| Phase | Phase 1, Phase 2 |
| Condition | Metastatic Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8 |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Edward Kim |
| Results posted | Yes |
2. Clinical Question
Population
Patients with hepatocellular carcinoma, including metastatic or unresectable disease and the listed stage III and stage IV categories. The study title describes treatment in the first- or second-line setting. The registry record lists enrollment of 8.
Intervention
The study combined IDO1 inhibitor BMS-986205 with nivolumab. The treatment description specifies oral BMS-986205 once daily on days 1-14 and nivolumab by intravenous infusion over 30 minutes on day 1. Courses were scheduled to repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Comparator
No concurrent comparator is listed. The registry describes a single-group study with allocation recorded as not applicable, so the posted results do not offer a like-for-like control group for comparison.
Primary question
The primary outcome counts participants with adverse events graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, with a timeframe of up to 2 years. The broader phase I/II purpose also concerned side effects, dose, and how well the combination worked. However, efficacy results for the listed secondary outcomes are not reported in the registry record.
3. Trial Design
This was a phase I/II, single-group trial of BMS-986205 and nivolumab for hepatocellular carcinoma. The registry lists enrollment of 8 and identifies the study status as terminated. The listed start date is 2018-10-16, and the primary completion date is 2020-11-24. The reason for termination is not reported in the registry record.
Allocation is recorded as not applicable, and masking as none. There is no listed control arm. Participants in the treatment group were scheduled to receive BMS-986205 by mouth once daily on days 1-14 and nivolumab intravenously over 30 minutes on day 1; courses were to repeat every 14 days while disease progression or unacceptable toxicity did not prevent treatment. The registry record does not report whether every participant received the planned schedule or how long each participant was treated.
The primary outcome was the number of participants with adverse events, assessed for up to 2 years and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Secondary outcomes listed in the record are Disease Control Rate (DCR), Progression-free Survival (PFS), Duration of Response (DOR), and Overall Survival (OS). Although the record lists six outcome measures, it lists no analyses. Definitions, assessment schedules, and analysis details for the secondary outcomes are not reported in the registry record.
The single-group design can describe events observed during treatment, but does not provide a concurrent control for separating treatment-associated events from other causes or for estimating comparative efficacy. The registry record does not report a statistical analysis plan, a planned sample-size justification, or the reason the trial stopped.
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 | Treatment (BMS-986205 and Nivolumab) |
|---|---|
| STARTED | 8 |
| COMPLETED | 8 |
| NOT COMPLETED | 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 | Treatment (BMS-986205 and Nivolumab) |
|---|---|---|
| Participants analysed | 8 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 |
| Age, Categorical: >=65 years | Participants | 6 |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Adverse Events (AE), measured over Up to 2 years..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Its stated timeframe is up to 2 years. This endpoint is used to characterize safety and tolerability: counts can show how many participants in the treated group experienced events meeting the registry’s adverse-event reporting criteria during the specified period.
A participant count is a descriptive summary, not a measure of event severity by itself. The registry’s primary-outcome description does not provide a breakdown of the count by grade, event type, duration, or attribution to treatment. Those details therefore cannot be inferred from the primary endpoint definition alone. The separate serious adverse-event information lists affected participants and selected terms, but it does not replace the endpoint’s full assessment.
In general, safety counts are important in early-phase research because they describe observed harms and can inform further study. They do not establish that an event was caused by treatment. In this single-group study, there is no concurrent control group to help distinguish events arising during treatment from events that might occur for other reasons. The registry record also does not report how adverse-event observations were handled for participants with incomplete follow-up.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports adverse-event counts for the treatment group: 2 participants are listed as affected by serious adverse events, with 8 at risk. For other adverse events, the record lists 8 participants affected, with 8 at risk. The record also lists 4 deaths. It does not state that these deaths were caused by treatment, nor does it provide their causes or timing in the information. Counts describe what was recorded; they do not, by themselves, establish causation.
The listed serious adverse-event terms are diarrhea, AST increase, hyperglycemia, and pancreatitis, each reported as 12.5%. The registry record does not specify the denominator or counting rules for these term-level percentages in the posted information. They should therefore be read as registry-reported percentages, not as independently reconstructed estimates. A term appearing in this list does not reveal its severity, duration, recurrence, or relationship to study treatment.
These results come from a single-group study with enrollment of 8 and no concurrent comparator. The adverse-event counts can describe events in the treatment group, but they cannot show how those counts compare with an untreated group or another treatment. They also cannot establish whether the regimen caused an event. The record lists no analyses, and inferential estimates such as confidence intervals or hypothesis tests are not reported in the registry record.
The study’s broader stated purpose included examining how well the combination worked, and the record names DCR, PFS, DOR, and OS as secondary outcomes. Results for those outcomes are not reported in the registry record. Accordingly, the adverse-event figures do not answer efficacy questions. Nor can the status “terminated” be interpreted as evidence of benefit, lack of benefit, or a particular safety concern: the reason for termination is not reported in the registry record.
Overall, the posted figures are descriptive observations from a limited, uncontrolled study. They provide a record of reported adverse events and deaths, but the information available does not support a comparative estimate or a causal conclusion. Uncertainty is substantial when a study has few participants, and the registry does not report interval estimates that would quantify that uncertainty for these counts.
9. Statistical Methods Explained
What does a participant count describe? The primary outcome is a count of participants with adverse events, rather than a continuous measurement or a time-to-event estimate. For a binary outcome, each participant is classified according to whether the event definition was met during the stated observation period. The resulting count is straightforward to interpret descriptively, but its meaning depends on the event definition, follow-up, and completeness of outcome collection. The registry record states the grading system and timeframe, but does not report detailed rules for handling incomplete follow-up or repeated events for this endpoint.
Counts need a denominator to convey how many people were observed and considered at risk. The adverse-event information reports at-risk counts for the treatment group alongside affected counts. Those figures describe the recorded group; they do not supply a comparison with a separate control group. A count also differs from an event rate: a participant may experience more than one event, while a participant count records whether that participant was affected according to the measure’s rules. The registry record does not provide the event-level details needed to reconstruct such rates.
What does uncertainty mean for these counts? A confidence interval is a statistical range that expresses uncertainty around an estimate under a specified method and assumptions. In general, estimates from small groups tend to be less precise than estimates from larger groups, because each participant’s outcome has more influence on the result. No confidence interval for the primary outcome is reported in the registry record. Without one, the posted counts remain descriptive and do not quantify the range of values compatible with sampling variability under a particular model.
In general, a hypothesis test evaluates how compatible data are with a specified null hypothesis under its assumptions. A p-value is not a measure of the probability that a treatment works, nor does it measure the size or clinical importance of an effect. The registry record lists no analyses, and no test or p-value for the primary outcome is reported. The absence of a reported test should not be replaced with a reconstructed significance claim.
Why does the design matter? This study has a single treatment group and no concurrent control. In general, observed events in a treated group can reflect the underlying illness, other care, chance, or treatment, and a single-group design cannot separate these explanations in the way a suitable comparison may help to do. Similarly, an uncontrolled outcome cannot establish how the outcome would have differed under another treatment. The registry record does not report a comparative estimate for efficacy.
The treatment schedule is described, but the record does not report adherence, individual exposure, or participant-level follow-up. These details can matter when interpreting safety counts: observation time may differ among participants, and exposure can affect opportunities to record events. The stated primary timeframe is up to 2 years; this does not establish that every participant was observed for the full timeframe.
How should secondary outcomes be understood? The registry lists DCR, PFS, DOR, and OS. In general, time-to-event outcomes such as PFS, DOR, and OS require information about when an event occurred and how follow-up ended. Participants who have no recorded event by the end of observation are commonly handled as censored under a defined analysis approach. The registry record does not report endpoint definitions, censoring rules, analysis methods, estimates, or results for these outcomes. DCR is also listed without its operational definition or a reported result.
The record lists six outcome measures but no analyses. This means the posted record does not describe how outcomes were evaluated statistically; it does not establish that no analyses occurred outside the record. Adjustment for baseline characteristics, handling of missing data, and analysis populations are not reported in the registry record. In general, these decisions can affect both estimates and their interpretation, especially when data are incomplete or outcomes are assessed at different times.
Any sample-size calculations based on an observed effect are planning illustrations, not observed power and not evidence that the study had a particular probability of detecting an effect. In general, such illustrations depend on assumptions about the effect, allocation, significance level, and statistical model. The registry record does not report the trial’s own sample-size justification or statistical plan, so an illustrative calculation should not be mistaken for the design rationale or a planned analysis.
10. Multiplicity, Missing Data and Analysis Populations
The record names several outcomes: adverse events as the primary outcome, and DCR, PFS, DOR, and OS as secondary outcomes. Testing or interpreting multiple outcomes can raise a multiplicity issue. In general, the more statistical questions examined, the greater the chance that at least one apparently notable result may arise by chance if all are treated as confirmatory. Researchers may address this through a prespecified testing hierarchy, adjustment, or a clear distinction between confirmatory and exploratory analyses. The registry record does not report a multiplicity strategy or statistical analysis plan.
The record lists six outcome measures and no analyses. Efficacy results and analysis details for the named secondary outcomes are not reported in the registry record. Their definitions, assessment schedules, and any intended priority among them are also not reported. It is therefore not possible to determine which outcomes, if any, were formally tested or how multiplicity was handled.
Missing-data handling is not reported in the registry record. This matters because participants may have different follow-up durations, and an outcome may be unavailable even when a participant entered the study. In general, the way missing observations are handled can influence estimates, particularly when missingness is related to health status, treatment discontinuation, or the outcome itself. The record does not describe imputation, censoring, or sensitivity analyses.
Analysis populations are likewise not reported. The registry does not specify which participants were included in each outcome analysis or how treatment exposure and protocol deviations were handled. These omissions limit assessment of how the posted counts relate to the planned study objectives. They should not be filled with assumptions about an intention-to-treat, per-protocol, or safety population.
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 |
|---|---|---|---|
| Treatment (BMS-986205 and Nivolumab) | 2 | 8 | 25.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment (BMS-986205 and Nivolumab) | 4 of 8 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Treatment (BMS-986205 and Nivolumab) | 8 of 8 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment (BMS-986205 and Nivolumab) |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | 1 of 8 |
| AST increase | Investigations | 1 of 8 |
| Hyperglycemia | Metabolism and nutrition disorders | 1 of 8 |
| Pancreatitis | Gastrointestinal disorders | 1 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment (BMS-986205 and Nivolumab) |
|---|---|---|
| AST increased | Investigations | 3 of 8 |
| ALT increased | Investigations | 3 of 8 |
| Diarrhea | Gastrointestinal disorders | 2 of 8 |
| Maculopapular rash | Skin and subcutaneous tissue disorders | 2 of 8 |
| Alk phos increased | Investigations | 2 of 8 |
| Oral pain | Gastrointestinal disorders | 1 of 8 |
| Flatulance | Gastrointestinal disorders | 1 of 8 |
| Pruritus | Skin and subcutaneous tissue disorders | 1 of 8 |
| Fatigue | General disorders | 1 of 8 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 8 |
Serious events with the highest arm-level rate: diarrhea (12.5%), ast increase (12.5%), hyperglycemia (12.5%), pancreatitis (12.5%).
The registry lists 2 participants affected by serious adverse events and 8 at risk in the treatment group. For other adverse events, it lists 8 affected participants and 8 at risk. These are descriptive participant counts. They do not indicate that every reported event was caused by the study treatment, and the record does not provide a concurrent control group for comparison.
The serious adverse-event terms listed are diarrhea, AST increase, hyperglycemia, and pancreatitis, each reported as 12.5%. The denominator and term-level counting rules are not reported in the registry record, so these percentages should be read as reported rather than used to infer additional counts. The term list does not show event grade, duration, recurrence, or treatment attribution.
The registry also lists 4 deaths. The information in the record does not establish when these deaths occurred, their causes, or whether they were related to treatment. A death reported in a trial record is not, by itself, evidence of a treatment-caused death. The record’s primary adverse-event timeframe is up to 2 years, but it does not establish that all participants had the same duration of follow-up.
12. What the Result Does, and Does Not, Mean
The record supports a descriptive reading of adverse events observed in the single treatment group. It reports 2 participants affected by serious adverse events, 8 affected by other adverse events, and 4 deaths. It also lists selected serious adverse-event terms, each with a reported percentage. These figures are observations recorded in the registry; they are not comparative treatment effects.
The study has no listed concurrent comparator, so the data do not show how the event counts would differ under another treatment or without the study combination. The record also does not establish that an event or death was caused by BMS-986205 or nivolumab. The serious-event term percentages lack a reported denominator and counting description in the posted information, which limits interpretation of those entries.
The trial’s title and summary describe a phase I/II investigation of side effects, dose, and treatment activity. However, efficacy results for DCR, PFS, DOR, and OS are not reported in the registry record. No analyses are listed. Thus, the adverse-event information cannot answer whether the combination improved outcomes, and no efficacy conclusion can be drawn from these figures.
The terminated status is a registry status, not an explanation. The reason for termination is not reported in the registry record. It should not be treated as proof that the treatment was ineffective, unsafe, or stopped for any particular reason. The registry also does not report the statistical plan, missing-data procedures, or analysis populations, so the precision and completeness of the reported outcomes cannot be fully assessed.
In general, a small uncontrolled study can provide descriptive information and help identify questions for further investigation, while leaving substantial uncertainty about rates and causality. The posted counts should therefore be understood as a limited account of outcomes in this study group, not as a forecast for other patients or a comparison between treatment options.
13. Why This Trial Matters Statistically
This trial illustrates the distinction between observing events and estimating a treatment effect. The registry reports adverse-event counts for a single treatment group, but no concurrent comparator. That design can document what was recorded during the study, while leaving open whether similar events would have occurred under another treatment or without the study combination.
The case also shows why endpoint definitions and analysis details matter. The primary outcome is a participant count for adverse events graded using a named criteria version and assessed for up to 2 years. Yet the registry record does not report a detailed event-counting method, analysis population, missing-data approach, or confidence interval. Without such information, readers can describe the recorded counts but have limited ability to assess precision or reproduce the analysis.
The record names secondary efficacy outcomes but does not report their results or analyses. Listing an outcome is not the same as reporting an estimate. This distinction is especially important when a study has several outcomes: interpretation depends on which questions were planned, how they were analyzed, and how multiplicity was addressed. Those details are not reported in the registry record.
Finally, the trial’s terminated status has no stated reason in the record. Statistical interpretation should separate that administrative status from evidence about safety or efficacy. Taken together, these features make the study a useful example of how design, reporting completeness, and uncertainty constrain what can be concluded from clinical-trial data.
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 registry record describes enrollment of 8 in a single-group study, with no concurrent comparator. As a result, the adverse-event figures are descriptive and cannot support a controlled comparison. The record does not report a reason for termination, so the study status cannot be used to infer why enrollment or follow-up ended.
The primary adverse-event outcome is stated as a participant count over a timeframe of up to 2 years. The record does not report individual follow-up durations, treatment exposure, adherence, detailed event-level data, or how incomplete observation was handled. The stated timeframe therefore should not be interpreted as uniform follow-up for every participant.
Although serious adverse-event terms are reported with percentages, the posted information does not identify the denominator or term-level counting rules. The record also does not report causes or timing for the listed deaths, or establish their relationship to treatment. This limits interpretation beyond the descriptive entries themselves.
The registry lists six outcome measures and no analyses. Definitions and results for the named secondary outcomes are not reported, nor are a statistical analysis plan, confidence intervals, multiplicity procedures, missing-data methods, or analysis populations. These gaps prevent evaluation of the intended inferential approach and the precision of outcome estimates. The registry record also does not report a sample-size justification or the reason the study was terminated.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer — NCT03695250.
- Registry record last updated 2026-07-29; status last verified 2026-07.
- Results first posted 2023-08-22.
- 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
NCT03695250 is a phase I/II, single-group study of BMS-986205 with nivolumab in hepatocellular carcinoma. The registry lists enrollment of 8, status as terminated, a start date of 2018-10-16, and a primary completion date of 2020-11-24. No comparator is listed.
The primary outcome counts participants with adverse events graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, with a timeframe of up to 2 years. The record lists 2 participants with serious adverse events, 8 with other adverse events, and 4 deaths. Four serious-event terms are reported at 12.5% each.
DCR, PFS, DOR, and OS are listed as secondary outcomes, but their results and analyses are not reported in the registry record. The reason for termination, statistical plan, and missing-data methods are also not reported.