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 Pembrolizumab and External Beam Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NCT03210662), a na phase 2 study. The primary outcome is Overall Response Rate of Pembrolizumab With Concurrent Fractionated External Beam Radiotherapy (EBRT) Among Patients With Relapsed and Refractory Non-Hodgkin Lymphoma (NHL).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03210662 |
| Phase | Phase 2 |
| Condition | Primary Mediastinal (Thymic) Large B-Cell Lymphoma, Recurrent Aggressive Non-Hodgkin Lymphoma, Recurrent Mature T- Cell and NK-Cell Non-Hodgkin Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients with relapsed or refractory non-Hodgkin lymphoma were the intended population. The listed conditions include several lymphoma subtypes, recurrent or refractory disease, and transformed lymphoma. The registry record gives an enrollment of 17, but does not report a fuller description of the participants who entered the primary endpoint analysis or how many had each listed condition.
Intervention
The study evaluated pembrolizumab together with fractionated external beam radiation therapy (EBRT). According to the treatment description, EBRT began on day 1 and was given daily for 5 consecutive days a week for up to 12 or 22 treatments. Pembrolizumab was given intravenously on day 2, with treatment repeating every 21 days for up to 35 cycles. The recorded stopping-condition text is incomplete.
Comparator
This was a single-group study, not a randomized comparison. The registry record does not describe a separate control group receiving pembrolizumab alone, radiation alone, or another treatment. Consequently, the study’s design does not make a like-for-like estimate of how the combination compares with either component or with another treatment.
Primary question
The primary endpoint was the overall response rate of pembrolizumab with concurrent fractionated EBRT among patients with relapsed or refractory non-Hodgkin lymphoma. Response was assessed using the revised Lugano classification, with PET-CT assessment for FDG-avid disease and Deauville scoring described in the record. The primary response result and its analysis are not reported in the registry record, so the response rate and its precision cannot be stated.
3. Trial Design
This was a phase II, single-group, open-label study sponsored by M.D. Anderson Cancer Center. The registry record lists enrollment of 17. Allocation is recorded as not applicable, and masking as none. These features describe a study without randomized assignment or blinding; they do not establish how participants were selected or whether the enrolled group represents patients beyond this trial.
The treatment combined pembrolizumab with fractionated external beam radiation therapy. EBRT was scheduled to begin on day 1 and to be administered daily for 5 consecutive days a week, for up to 12 or 22 treatments. Pembrolizumab was administered intravenously over 1 hour on day 2, with cycles repeating every 21 days for up to 35 cycles. The recorded description of treatment stopping conditions ends incompletely, so the full protocol rule is not reported in the registry record.
The study began on 2018-02-01. Its primary completion date is 2025-10-28, and its status is completed. The primary response endpoint was assessed every 3 months until withdrawal of consent, loss to follow-up, or death; the recorded timeframe gives an average of 14 months. This is a planned assessment schedule and timeframe, not a reported duration for every participant.
Secondary outcomes listed in the registry record include progression-free survival, overall survival, response in irradiated versus non-irradiated lesions, and safety of pembrolizumab with fractionated EBRT. Although the record lists five outcome measures, it reports no analyses. The primary response result and details such as the analysis population and statistical testing plan 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 | Total |
|---|---|
| STARTED | 17 |
| COMPLETED | 0 |
| NOT COMPLETED | 17 |
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 | Total |
|---|---|---|
| Participants analysed | 17 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 |
| Age, Categorical: >=65 years | Participants | 9 |
| Age, Continuous | years | 59.9 (24 to 83) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 12 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 14 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| 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 | 13 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 17 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Response Rate of Pembrolizumab With Concurrent Fractionated External Beam Radiotherapy (EBRT) Among Patients With Relapsed and Refractory Non-Hodgkin Lymphoma (NHL), measured over Every 3 months until withdrawal of consent, becoming lost to follow-up, or death (an average of 14 months)..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is named as the overall response rate for pembrolizumab with concurrent fractionated EBRT. In general, an overall response endpoint summarizes whether participants meet prespecified criteria for tumor response during an assessment period. It is used to describe observed antitumor activity in the population studied; it does not, by itself, establish how an intervention compares with another treatment.
The registry record says disease response was assessed using the revised Lugano classification for Hodgkin and non-Hodgkin lymphoma. For patients with FDG-avid disease, the end-of-treatment assessment was based on PET-CT, and Deauville criteria were used for PET-CT scoring. The record describes a 5 point 5-point scale, with scores of 1-3 considered negative and scores of 4-5 considered positive for active lymphoma. These assessment details identify how imaging findings were interpreted, but the record does not provide the primary endpoint result.
The endpoint’s unit is participants and its recorded parameter is a count of participants. The response count, denominator used to calculate a rate, handling of missing assessments, and confidence interval are not reported in the registry record. Without those results, neither the size of the observed response nor the precision of an estimated rate can be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive limitation is that the registry record does not report the primary response result. It identifies overall response rate as the primary endpoint and describes the response assessment, but it gives no response count, rate, confidence interval, or analysis. Therefore, the posted record does not establish the magnitude or precision of response in this study population. No conclusion about how well the treatment worked can be drawn from the listed endpoint title or assessment rules alone.
The study’s single-group design also limits interpretation. Any reported response within a treated group would describe outcomes among participants receiving the combination, but without a randomized comparison it could not isolate the contribution of pembrolizumab, radiation, or their combination. Differences in patient characteristics, disease course, or other care could not be balanced against a concurrent control by random assignment. The registry record does not list a control group.
The registry describes a planned repeated response assessment every 3 months until withdrawal of consent, loss to follow-up, or death, with an average timeframe of 14 months. This does not show how many assessments occurred or whether participants were followed for the same duration. The primary completion date of 2025-10-28 is a registry milestone, not a substitute for individual follow-up results.
The record lists secondary outcomes for progression-free survival, overall survival, lesion response by irradiated status, and safety. It does not report analyses for these outcomes. Their presence in a registry entry should not be mistaken for findings. In particular, no comparative effect between irradiated and non-irradiated lesions, or survival estimate, can be inferred from the outcome names.
Safety information is reported as counts of participants with serious and other adverse events, along with selected serious adverse-event terms. These figures describe events recorded in the trial and should be read separately from efficacy. The record does not give event attribution, timing, duration, or severity grades for these summaries. The deaths count also does not establish that deaths were caused by treatment. Overall, the record provides design and selected safety counts but not the response or secondary-outcome analyses needed to characterize efficacy or its uncertainty.
9. Statistical Methods Explained
In general, a single-group phase II study can describe outcomes observed after participants receive a treatment regimen. It does not use random assignment to create a concurrent comparison group. In this study, the regimen combined pembrolizumab with fractionated EBRT, so an outcome in the treated group would pertain to the combination as administered. Without a control arm, it cannot cleanly separate effects attributable to one component from those attributable to the other, or distinguish treatment effects from other explanations for outcomes.
The registry record lists allocation as not applicable and masking as none. In general, masking means keeping participants, clinicians, or outcome assessors unaware of assigned treatment. With no masking recorded, subjective decisions and reporting can potentially be influenced by knowledge of treatment, although imaging-based criteria may provide structured assessment rules. The record does not state whether image reviewers were independently masked, so that detail is not reported in the registry record.
The primary measure is a count of participants for an endpoint titled overall response rate. In general, a rate expresses the share of an eligible analysis group that meets the response definition. Interpretation requires both the numerator and a clear denominator, along with rules for participants who lack a response assessment. The registry record does not report those primary results or denominator rules. The revised Lugano classification and PET-CT/Deauville assessment description explain the response framework, but they cannot replace the missing outcome data.
In general, a confidence interval expresses uncertainty around an estimate under the assumptions of its statistical method. A narrow interval indicates greater statistical precision than a wide interval, while neither interval alone resolves design limitations or possible bias. No interval for the primary response result is reported in the registry record. A p-value, if reported, would address compatibility with a specified statistical hypothesis under model assumptions; it would not by itself quantify the clinical importance of a result. No primary p-value or statistical test is reported.
The record lists an average of 14 months for the response assessment timeframe and says assessments were scheduled every 3 months until withdrawal of consent, loss to follow-up, or death. These details concern when outcome assessments were intended to occur. In general, repeated assessment may show how an outcome evolves over time, but interpretation depends on actual assessment completion and timing. Those participant-level details are not reported in the registry record.
The record also lists planning illustrations based on an observed effect, 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. For time-to-event calculations, the stated planning quantity is total events; other planning quantities are participants per arm. These are hypothetical design illustrations, not observed power and not the trial’s own single-group design. In general, sample-size planning asks how much information a proposed design might need to detect a chosen effect under stated assumptions. Such calculations depend on the effect and assumptions used, and do not show that the study actually had that probability of detecting an effect. The registry record does not report its own sample-size justification or statistical plan.
Over-dispersion is a general statistical concern when outcomes vary more than a model’s assumptions allow. It can make standard errors too small if ignored and can make confidence intervals or tests misleading. The posted primary outcome is a participant count, but the registry record does not report a model, variance assumption, or analysis that would permit assessment of over-dispersion. It would be inappropriate to infer a particular count model from the endpoint’s unit alone.
For time-to-event outcomes, general methods account for both event times and censoring, when a participant’s event time is not observed during follow-up. The record lists progression-free and overall survival as secondary outcomes, but no outcome estimates, event counts, censoring details, or analysis methods are reported. The stated planning convention for total events does not provide trial results. Likewise, a planned comparison of irradiated and non-irradiated lesion response would require its own analysis details; none are reported.
The registry lists five outcome measures and zero analyses. This means the record does not supply statistical analyses to interpret for these outcomes. It does not establish whether analyses were performed outside the registry. The statistical test choices, adjustment strategy, analysis populations, missing-data procedures, and sensitivity analyses are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists five outcome measures, including the primary overall response endpoint and secondary survival, lesion-response, and safety outcomes. When a study assesses multiple endpoints or conducts multiple tests, the chance of at least one apparently unusual result can rise. In general, a prespecified multiplicity strategy can define which outcomes are confirmatory and how statistical error is controlled. The statistical plan and any multiplicity adjustment are not reported in the registry record. Since no analyses are listed, the record also does not show whether any tests were conducted or how their results were interpreted.
Missing outcome data can affect both the estimated response and its precision. In general, interpretation depends on how many participants had evaluable assessments, why data were missing, and how missing participants were handled. For this trial, the response assessment timeframe ends at withdrawal of consent, loss to follow-up, or death, but the record does not report the number of missing or unevaluable assessments or the analysis rules for them. The response denominator and analysis population are also not reported in the registry record.
The registry lists enrollment of 17, but enrollment alone does not specify how many participants contributed to each outcome analysis. The adverse-event group records 17 at risk for its listed safety summaries; that does not identify the efficacy analysis population. The record does not report whether all enrolled participants were included in the primary analysis, or whether any participants were excluded and why. No imputation method, missing-data sensitivity analysis, or analysis population definition is reported in the registry record.
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 |
|---|---|---|---|
| Total | 10 | 17 | 58.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Total | 14 of 17 |
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 |
|---|---|
| Total | 16 of 17 |
Most frequent serious adverse event terms
| Event term | Organ system | Total |
|---|---|---|
| Lung Infection | Infections and infestations | 2 of 17 |
| Platelet Count Decreased | Blood and lymphatic system disorders | 2 of 17 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 17 |
| Hypoxia | Investigations | 1 of 17 |
| Delirium | General disorders | 1 of 17 |
| Abdominal pain | Gastrointestinal disorders | 1 of 17 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 17 |
| Flank pain | Musculoskeletal and connective tissue disorders | 1 of 17 |
| Tumor pain | Infections and infestations | 1 of 17 |
| Lymph node pain | Blood and lymphatic system disorders | 1 of 17 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Total |
|---|---|---|
| Fatigue | General disorders | 11 of 17 |
| Radiation Dermatitis | Skin and subcutaneous tissue disorders | 5 of 17 |
| Anemia | Blood and lymphatic system disorders | 4 of 17 |
| Prutirus | Skin and subcutaneous tissue disorders | 4 of 17 |
| Pain | General disorders | 3 of 17 |
| Diarrhea | Gastrointestinal disorders | 3 of 17 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 3 of 17 |
| Nausea | Gastrointestinal disorders | 3 of 17 |
| Lung infection | Infections and infestations | 3 of 17 |
| Platelet Count Decreased | Investigations | 2 of 17 |
Serious events with the highest arm-level rate: lung infection (11.8%), platelet count decreased (11.8%), dyspnea (5.9%), hypoxia (5.9%), delirium (5.9%).
The registry’s safety summary lists 17 participants at risk for the serious and other adverse-event categories. It records 10 participants affected by serious adverse events and 16 affected by other adverse events. These are participant counts, not event counts: a participant may have experienced more than one event, and the record does not describe how repeated events were handled in the summary.
The most frequently listed serious adverse-event terms are Lung Infection and Platelet Count Decreased, each reported as 11.8%. Dyspnea, Hypoxia, Delirium, and Abdominal pain are each reported as 5.9%. These percentages are registry figures; the record does not provide further detail on event timing, duration, severity grading, or whether events were considered related to study treatment.
The safety group also records 14 deaths. The record does not attribute these deaths to treatment, nor does it give causes or timing. A death count should not be interpreted as a treatment-caused death count. In general, serious adverse events are a regulatory seriousness category and are not interchangeable with the most severe grade of an event. The record does not report event grades, so severity cannot be reconstructed from these figures.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a phase II, single-group study evaluated pembrolizumab with fractionated EBRT in relapsed or refractory non-Hodgkin lymphoma. It records enrollment of 17 and describes a response-assessment framework based on revised Lugano criteria, with PET-CT and Deauville scoring for FDG-avid disease. It also supplies selected adverse-event counts and terms. These details describe the design and some recorded safety information.
They do not establish the primary response rate. The primary endpoint result, its denominator, and any estimate of precision are not reported in the registry record. The listed response criteria indicate how disease response was to be assessed, not what responses were observed. The record also does not report analyses for the secondary outcomes, including survival and comparisons of irradiated with non-irradiated lesions.
Even if response outcomes were available, a single-group design would support description of outcomes under the combination rather than a controlled estimate of its effect relative to another treatment. There is no randomized comparator in the registry record. The design therefore cannot establish whether any observed outcome was due to pembrolizumab, radiation, their combination, or other influences.
The adverse-event summaries show participants affected and selected event terms, but do not establish causal attribution. The death count is not a count of deaths attributed to treatment. Further information about event timing, grading, and attribution is not reported in the registry record. The study’s listed outcomes and its completed status likewise do not substitute for posted results. The appropriate interpretation is therefore limited: the record describes what the trial set out to assess and gives selected safety counts, while leaving the primary response findings and their uncertainty unreported.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between a registered endpoint and a reported result. The registry names overall response rate as the primary endpoint and describes its assessment criteria, but does not report the response count or rate. Without the outcome estimate and its denominator, readers cannot assess either the observed response magnitude or the precision of that estimate.
The single-group design is also important to interpretation. A treated-group outcome can describe what happened in the study population, but the absence of a randomized comparator prevents a direct, balanced estimate of how outcomes differ under another treatment. This matters particularly when the treatment combines two components: a response in the group would not by itself identify the contribution of each component.
The entry also illustrates why enrollment and outcome denominators should not be conflated. Enrollment is listed as 17, and the safety summary gives its own at-risk count. The primary response analysis population and denominator are not reported. In general, an estimate’s interpretation depends on who contributed data and how missing assessments were handled.
Finally, the listed secondary outcomes and safety terms demonstrate that a registry can contain substantial design information without presenting statistical analyses. Registered outcomes are not equivalent to results, and a completed study status does not resolve the absence of endpoint estimates. The statistical value of the record lies in its account of the intended question, treatment structure, timing, and selected safety counts, while the principal efficacy evidence remains unavailable in the registry record.
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 primary limitation is missing efficacy reporting: the registry record does not report the primary response count or rate, its denominator, confidence interval, or statistical analysis. It also reports no analyses for the listed outcomes. As a result, the principal efficacy question cannot be answered from this record, and the precision of any primary estimate cannot be evaluated.
The single-group, unmasked design limits comparative interpretation. There is no randomized control group in the registry record, so outcomes cannot be directly contrasted with another treatment under balanced assignment. Since pembrolizumab and EBRT were given together, the design would not isolate their separate contributions. The registry does not report whether outcome assessors were masked.
The record describes varied lymphoma conditions, but does not report how enrollment was distributed across the listed subtypes or provide a fuller account of participants contributing to each analysis. It does not state the primary analysis population, handling of unevaluable response assessments, or missing-data methods. These omissions matter when interpreting a participant count or response rate.
The treatment description’s stopping-condition text is incomplete. Although assessment was scheduled every 3 months until withdrawal of consent, loss to follow-up, or death, the record does not give actual follow-up or assessment completion for participants. Safety information is also limited: event attribution, timing, duration, and grading are not reported, and the deaths count has no stated cause or treatment relationship. Sample-size justification, interim analyses, and the statistical plan are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pembrolizumab and External Beam Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma — NCT03210662.
- Registry record last updated 2026-01-13; status last verified 2026-01.
- Results first posted 2026-01-13.
- 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
This completed phase II study evaluated pembrolizumab with fractionated external beam radiation therapy in patients with relapsed or refractory non-Hodgkin lymphoma. It was single-group and unmasked, with enrollment of 17. The primary endpoint was overall response rate, assessed using revised Lugano criteria and, for FDG-avid disease, PET-CT with Deauville scoring.
The registry record describes treatment scheduling and lists secondary outcomes for progression-free survival, overall survival, lesion response, and safety. It reports selected adverse-event counts and terms, including 10 participants with serious adverse events and 14 deaths, without establishing treatment attribution. The primary response result and analyses of the listed outcomes are not reported in the registry record. Accordingly, efficacy magnitude, precision, and comparative effects cannot be assessed from the posted results.