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 Lymphoma RadVax LYMPHOMA: A PHASE II TRIAL OF NIVOLUMAB + LOW DOSE RADIOTHERAPY FOR INCOMPLETE RESPONDERS (NCT03495713), a na phase 2 study. The primary outcome is Complete Response Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03495713 |
| Phase | Phase 2 |
| Condition | Hodgkin Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 7 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Abramson Cancer Center at Penn Medicine |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerns patients with relapsed or refractory Hodgkin lymphoma. Its summary describes the study question as focused on patients who do not achieve a complete response to nivolumab alone. Specific eligibility criteria are not reported in the registry record.
Intervention
Participants began treatment with nivolumab. After the first restaging scan, those without an anatomic complete response were to receive low-dose involved-site radiotherapy, described as 4 Gy x 2. Participants with an anatomic complete response were to continue nivolumab alone.
Comparator
There was no randomized control group or like-for-like comparison arm. The registry describes a single-group trial, so the design does not directly compare the combined approach with nivolumab alone in otherwise comparable groups.
Primary question
The primary endpoint was complete response rate, assessed by a restaging scan at 25 weeks. The study’s stated aim was to assess response in the context of adding radiotherapy for patients who had not achieved a complete response to nivolumab alone. The numerical endpoint result is not reported in the registry record.
Statistically, this is a question about the response observed under a treatment strategy in which radiotherapy depended on the restaging result. It is not a randomized test of the separate contribution of radiotherapy. The registry’s description identifies the intended treatment sequence, but does not report enough outcome information to quantify the complete response rate or its precision.
3. Trial Design
NCT03495713 is a phase II, single-group, open-label trial listed for Hodgkin lymphoma. The registry identifies Abramson Cancer Center at Penn Medicine as the sponsor and describes the study as single-site. Enrollment is listed as 7. The trial began on 2018-11-02, has a primary completion date of 2022-04-20, and is marked terminated. The reason for termination is not reported in the registry record.
The treatment strategy began with nivolumab. At the first restaging scan, patients with less than an anatomic complete response were to receive low-dose involved-site radiotherapy, described as 4 Gy x 2. Patients with an anatomic complete response were to continue nivolumab without radiotherapy. Thus, radiotherapy was assigned according to an observed response after treatment had begun, rather than being allocated randomly at the outset.
The registry lists no masking and no randomized allocation. The design therefore does not support a direct randomized comparison between nivolumab alone and nivolumab followed by radiotherapy. Differences in outcomes between patients who did and did not receive radiotherapy could reflect their response status or other differences, as well as any treatment effect.
The primary endpoint is complete response rate determined by a restaging scan at 25 weeks. The registry record does not report the response criteria, the analysis population, or the numerical endpoint result. It also does not report a sample-size justification or a detailed statistical analysis plan. The planning assumptions listed with the record are illustrations, not evidence of the trial’s original design.
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 | Single Arm |
|---|---|
| STARTED | 7 |
| COMPLETED | 7 |
| 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 | Single Arm |
|---|---|---|
| Participants analysed | 7 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | Years | 29 (20 to 51) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Complete Response Rate, measured over 25 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is complete response rate, with the unit recorded as participants. The registry describes it as an overall complete response rate determined by a restaging scan, with a timeframe of 25 weeks. In general, a binary endpoint classifies each assessed participant into a category such as complete response or not complete response. A response rate describes the proportion classified as having the outcome, while a participant count reports how many meet the endpoint definition.
A scan-based endpoint is used to assess whether the disease meets the study’s definition of complete response at the specified assessment. The endpoint description does not state the response criteria, the scan procedures, or who reviewed the scans. Those details are not reported in the registry record, so the reproducibility and assessment process cannot be evaluated from this entry.
The registry identifies the endpoint but does not report the observed complete-response count or rate. It also does not provide an interval estimate that would show the precision of the result. Consequently, the endpoint’s planned meaning can be described, but its numerical outcome cannot be interpreted from the registry record. The 25-week assessment is the stated endpoint timeframe; it should not be treated as a report of longer-term response or durability.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies complete response rate at 25 weeks as the primary endpoint, but does not report its numerical result. There is therefore no posted endpoint estimate to interpret, and the response count, response rate, and precision of that estimate are not reported in the registry record. The fact that an endpoint and an analysis are listed does not supply the outcome values needed to evaluate the result.
Enrollment is listed as 7, but the record does not state how many participants were assessed for the primary endpoint or how missing assessments were handled. Enrollment alone cannot establish the endpoint denominator. It would be inappropriate to infer a response count or rate from enrollment, or to assume that every enrolled participant completed the assessment.
The design also limits what a response result could establish. This was a single-group, open-label trial without randomized allocation. Radiotherapy was planned for patients who had less than an anatomic complete response after nivolumab, while those with an anatomic complete response were to continue nivolumab alone. Because the treatment groups would be formed according to response status, their outcomes would not constitute a like-for-like comparison of radiotherapy versus no radiotherapy. Any difference between those groups could not be attributed to radiotherapy alone on the basis of this design.
General statistical context: an estimate from a small study can be imprecise, and a confidence interval expresses the range of values compatible with the observed data under the interval method’s assumptions. The registry record does not give an endpoint estimate or confidence interval, so neither the magnitude nor the precision of the primary result can be assessed. The absence of a reported estimate is not evidence that the endpoint was met or not met.
The record is marked terminated, but the reason is not reported in the registry record. Termination status by itself does not explain whether the study stopped for administrative, recruitment, safety, efficacy, or other reasons. No conclusion about the reason for termination or its effect on the analysis can be drawn from this entry.
9. Statistical Methods Explained
The registry identifies a binary primary endpoint: complete response rate, assessed by a restaging scan at 25 weeks. It does not report the endpoint result or detailed methods for its analysis. The following explains relevant statistical concepts in general; it does not describe unreported procedures as though they were used in this trial.
What does a binary endpoint represent?
General explanation: a binary endpoint records whether each assessed participant meets a stated outcome definition. A count reports the number meeting that definition. A rate relates that count to the number of participants assessed, using a clearly specified denominator. Interpretation depends on knowing both the numerator and denominator, along with the rules used to classify outcomes.
For this trial, the registry names complete response and a scan-based assessment, but does not report the response criteria, observed count, rate, or assessment denominator. It also does not say how participants without an evaluable scan were treated. These missing details prevent a reader from reconstructing the endpoint analysis.
Why does precision matter?
General explanation: a point estimate is an estimate based on the observed study data. A confidence interval describes statistical uncertainty around that estimate under a specified method. Wider intervals indicate less precision; narrow intervals indicate greater precision, although neither interval width nor the estimate alone resolves limitations in study design.
The registry record does not report a primary endpoint estimate or confidence interval. No numerical claim about the response rate or its precision can therefore be made. With enrollment listed as 7, the amount of information available may be limited, but the endpoint denominator is not stated, and no precision measure is posted.
What does a single-group design allow?
General explanation: a single-group study can describe outcomes among participants treated under the study strategy. Without a comparable control group, it generally cannot separate the treatment strategy’s effect from other explanations, such as the natural course of disease, participant characteristics, assessment practices, or changes over time.
This trial’s strategy also made radiotherapy conditional on the result of the first restaging scan. Participants who did not have an anatomic complete response were to receive radiotherapy, while those who did have one were to continue nivolumab alone. A comparison between these groups would start with participants who differed in response status. It would not be a randomized comparison of radiotherapy with no radiotherapy.
What do the planning assumptions describe?
The registry includes sample-size assumptions for a planning illustration based on an observed effect. The stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. These assumptions are described as a planning illustration, not as the trial’s own design. They do not turn this single-group trial into a two-arm comparison, and they are not observed power or evidence about the primary endpoint result.
General explanation: sample-size planning explores how much information a future study might need under specified assumptions. Such calculations depend on the target effect, error rates, allocation, and analysis method. A planning illustration is conditional on those choices; it does not establish that the assumed effect is real or that a study will achieve a particular result. The registry record does not report a trial-specific sample-size justification.
What analysis details remain unknown?
The registry lists one analysis but does not provide its statistical method, an estimate, or an uncertainty interval. The analysis population, handling of missing assessments, and any adjustment for other factors are not reported in the registry record. It is also not reported whether scans were reviewed independently or whether endpoint classification was blinded. These omissions limit assessment of both reproducibility and potential sources of bias.
General explanation: methods should be interpreted alongside the data they analyze. A stated endpoint does not reveal the analysis population; an enrollment figure does not reveal the number with an evaluable outcome; and a planning assumption does not substitute for an observed estimate. Here, the design and endpoint can be described, but the missing endpoint result means the primary statistical finding cannot be evaluated.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Single Arm | 7 | 7 | 100.0% | 59.0% to 100.0% | 64.6% to 100.0% | 63.1% to 99.7% |
R code and output
arm <- c("Single Arm")
n <- c(7)
events <- c(7)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Single Arm 7 7 100.0 59.0 100.0 64.6 100.0 63.1 99.711. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and one analysis. It does not report whether additional outcomes or exploratory analyses were conducted, whether there were multiple comparisons, or whether any adjustment for multiplicity was planned. The multiplicity strategy is not reported in the registry record.
General explanation: when an analysis makes multiple statistical comparisons, the chance of at least one apparently notable finding can increase. Prespecified priorities and an appropriate multiplicity strategy help clarify how results should be interpreted. The number of outcomes listed in a registry entry does not, by itself, establish the full set of analyses performed.
The record identifies the primary endpoint timeframe as 25 weeks but does not state how missing scans, withdrawals, or participants without an evaluable assessment were handled. It does not report whether outcomes were imputed, whether participants were excluded from the endpoint analysis, or what denominator was used. These missing-data procedures are not reported in the registry record.
The analysis population is also not specified. It is therefore unclear from this entry whether the analysis included all enrolled participants or a defined subset. Enrollment is listed as 7, but that figure does not establish how many contributed to the primary endpoint analysis. No assumptions about missingness or analysis populations should be attributed to the study without a reported method.
These gaps matter because analysis choices can affect both the estimate and its uncertainty. Without an analysis population, missing-data approach, and multiplicity information, the completeness and interpretability of the reported analysis cannot be assessed. In this case, the numerical primary endpoint result is also not reported in the registry record.
12. 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 |
|---|---|---|---|
| Single Arm | 2 | 7 | 28.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Single Arm | 0 of 7 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Single Arm | 2 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Single Arm |
|---|---|---|
| Non-cardiac chest pain | Cardiac disorders | 1 of 7 |
| Pregnancy loss | Pregnancy, puerperium and perinatal conditions | 1 of 7 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Single Arm |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | 1 of 7 |
| Anaphylaxis | Blood and lymphatic system disorders | 1 of 7 |
Serious events with the highest arm-level rate: non-cardiac chest pain (14.3%), pregnancy loss (14.3%), dyspnea (14.3%).
The registry’s serious adverse-event fields list 7 at risk and 2 affected in the single-arm group. The other adverse-event fields also list 7 at risk and 2 affected. The record lists 0 deaths. These are the figures recorded for the group; the registry entry does not provide further detail about event timing, duration, severity grading, or the observation period used for safety reporting.
The listed serious adverse-event terms are non-cardiac chest pain, pregnancy loss, and dyspnea, each reported as 14.3%. The record does not explain whether these terms occurred in the same or different participants, or whether a participant could contribute more than one event term. The percentages should therefore be read as the registry’s reported term-level figures, not as evidence that the terms are mutually exclusive.
General explanation: safety counts describe events recorded under a study’s reporting definitions and monitoring period. They do not, on their own, establish that a treatment caused an event. Interpretation depends on the definitions, follow-up, and context, some of which are not reported in the registry record. The listed counts should not be compared with another study unless the populations and reporting methods are sufficiently comparable.
13. What the Result Does, and Does Not, Mean
The registry record describes a phase II, single-group study of a treatment strategy beginning with nivolumab and adding low-dose radiotherapy for participants without an anatomic complete response at the first restaging scan. Its primary endpoint is complete response rate at 25 weeks. However, the numerical primary endpoint result is not reported in the registry record, so the observed response rate and its precision cannot be stated.
The design is not a randomized comparison. Radiotherapy was to be given according to response after nivolumab, rather than assigned at random between comparable groups. Therefore, the study design cannot isolate the effect of radiotherapy by comparing participants who received it with those who continued nivolumab alone. Their response status already distinguished the groups.
General explanation: an observed response in a single-group study describes what happened among participants treated under that study’s strategy. It does not by itself establish what would have happened to the same participants under a different strategy. A randomized comparison can help address that counterfactual question, but this trial is not described as randomized.
The enrollment figure of 7 does not reveal the number assessed for the primary endpoint, and the record does not report its analysis population or missing-data handling. The safety fields and listed adverse-event terms provide separate safety information, but they do not supply the missing primary endpoint result. The terminated status likewise does not explain why the trial stopped; the reason is not reported in the registry record.
Accordingly, the record supports a description of the trial’s design, treatment sequence, endpoint, and listed safety figures. It does not support a numerical conclusion about the primary response outcome, a causal estimate for radiotherapy, or a conclusion about the reason for termination.
14. Why This Trial Matters Statistically
This trial raises a useful statistical issue: the treatment strategy is response-adaptive. Participants began with nivolumab, and the planned use of radiotherapy depended on the first restaging result. That structure matters when interpreting outcomes because treatment exposure and prior response status are linked. A simple comparison of those receiving radiotherapy with those not receiving it would not represent a randomized treatment contrast.
The study also illustrates the distinction between an endpoint being registered and an endpoint result being available in the registry record. Complete response rate at 25 weeks is clearly identified as the primary endpoint, but its numerical result and precision are not reported. Without those values, readers cannot assess the observed response pattern or how uncertain an estimate might be.
Enrollment is listed as 7, and the study is single-group and open-label. Those design features make careful attention to uncertainty, assessment procedures, and analysis populations especially important. Yet the registry record does not report the endpoint denominator, scan criteria, missing-data method, or detailed analysis plan. These are not minor substitutes for results; they are information needed to understand how a result would have been obtained and how much confidence to place in it.
Finally, the record’s terminated status and safety figures should be read separately from the efficacy question. The reason for termination is not reported, and safety listings do not provide the missing complete response estimate. The statistical value of the record is therefore chiefly in clarifying the intended design and the limits of what can be concluded from the posted information.
15. 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.
Several trial-specific details needed to judge the primary endpoint are not reported in the registry record. These include the complete-response criteria, scan procedures, the endpoint analysis denominator, and the handling of participants without an evaluable scan. The record also does not specify the analysis population or provide the statistical method used for the listed analysis.
The trial is described as single-site, open-label, and single-group, with no randomized allocation. The treatment sequence makes radiotherapy conditional on response after nivolumab. This prevents a like-for-like randomized comparison of radiotherapy versus no radiotherapy and leaves the contribution of radiotherapy indistinguishable from differences in response status in any such group comparison.
Enrollment is listed as 7, but the number assessed at the primary endpoint is not reported. The registry does not provide a numerical complete response result or an interval estimate. Its terminated status is recorded, but the reason for termination and any implications for follow-up or analysis are not reported. The primary endpoint timeframe is 25 weeks; longer-term response outcomes are not reported in the registry record.
For safety, the record lists affected and at-risk figures, serious adverse-event terms, and deaths, but does not report the safety observation period or further event-level context. The summary of the arm description does not provide complete eligibility details, and specific inclusion and exclusion criteria are not reported. These limits restrict assessment of outcome measurement, generalizability, and the completeness of the reported analysis.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Lymphoma RadVax LYMPHOMA: A PHASE II TRIAL OF NIVOLUMAB + LOW DOSE RADIOTHERAPY FOR INCOMPLETE RESPONDERS — NCT03495713.
- Registry record last updated 2024-01-17; status last verified 2023-12.
- Results first posted 2023-06-28.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT03495713 is a phase II, single-group, open-label, single-site trial concerning relapsed or refractory Hodgkin lymphoma. The sponsor is Abramson Cancer Center at Penn Medicine. Enrollment is listed as 7; the trial began on 2018-11-02, has a primary completion date of 2022-04-20, and is marked terminated.
The planned strategy began with nivolumab, with low-dose involved-site radiotherapy described as 4 Gy x 2 for patients without an anatomic complete response after the first restaging scan. The primary endpoint is complete response rate by restaging scan at 25 weeks. The numerical primary endpoint result, analysis population, missing-data methods, and reason for termination are not reported in the registry record.
The safety record lists 2 affected and 7 at risk in the serious adverse-event fields, 0 deaths, and three serious adverse-event terms reported at 14.3% each. These figures do not replace the missing primary endpoint result.