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 Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma (NCT03370276), a non-randomized phase 1, phase 2 study. The primary outcome is Phase II: Overall Survival (OS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03370276 |
| Phase | Phase 1, Phase 2 |
| Condition | Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Oral Cavity |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 95 |
| Arms in the primary outcome | n/a |
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Results posted | Yes |
2. Clinical Question
Population
Participants with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC), including cancers of several head and neck sites. The primary endpoint population is described as evaluable participants. The registry record lists an enrollment of 95.
Intervention
Concurrent cetuximab and nivolumab. The study included a phase I component with cetuximab dose escalation and a phase II component using the recommended phase II dose of cetuximab with nivolumab.
Comparator
There is no randomized control group identified. The registry lists phase I and phase II cohorts, but the study is non-randomized, so cohort outcomes should not be treated as a like-for-like comparison of assigned treatments.
Primary question
The phase II primary endpoint is median overall survival, with a 90% confidence interval, for evaluable participants receiving the combination. The endpoint description also frames the objective as one-year overall survival. The registry record does not report the primary endpoint result.
The study concerns people with recurrent and/or metastatic HNSCC and evaluates the combination of cetuximab and nivolumab. Its phase I component addresses dose escalation, while its phase II component assesses the combination at the recommended phase II dose. The registry describes the treatments as having been used separately in this cancer, but that background does not establish what the combination achieved in this study.
The statistical question is whether the posted phase II overall-survival estimate is informative about survival after treatment in the evaluated participants, and how much uncertainty surrounds that estimate. Overall survival is defined in the registry as time from treatment start until death from any cause. However, no median, confidence interval, hazard ratio, or other primary endpoint result is reported in the registry record. Consequently, the clinical question cannot be answered from the outcome information recorded there.
The non-randomized design also matters to interpretation. Cohort outcomes describe the participants in those cohorts, but they do not create a controlled comparison. Differences between cohorts, if reported elsewhere, could reflect differences in who entered them or how they were treated, rather than an effect of treatment. The registry record does not identify a randomized comparator.
3. Trial Design
This is a phase I/II, parallel, non-randomized study with no masking. It evaluated concurrent cetuximab and nivolumab in participants with recurrent and/or metastatic HNSCC. The registry lists enrollment of 95 and a completed status. The listed study dates are 2017-12-20 for the start and 2021-09-04 for primary completion.
The phase I component is described as dose escalation of cetuximab with nivolumab. It has separate entries for affiliate sites and the Moffitt site. The phase II component is also listed separately by site, and both entries describe nivolumab and cetuximab at the recommended phase II dose. The registry text does not provide enough complete phase I dosing detail to describe all dose levels. It also does not report how participants were assigned to cohorts or sites.
Phase I and phase II serve different purposes in a development program. In general, a dose-escalation component explores dosing, while a later-phase component evaluates outcomes at a selected dose. Those broad purposes do not establish the exact decision rules used in this study. Details such as dose-escalation rules, stopping criteria, and the basis for selecting the recommended phase II dose are not reported in the registry record.
The registry identifies overall response rate, progression-free survival, and treatment-related adverse events as secondary outcomes. It lists five outcome measures overall, but does not report outcome analyses. There is no randomized allocation, masking, or like-for-like control comparison identified. The registry record does not report the statistical analysis plan, the sample-size justification, interim analyses, or the rules for assigning participants to analysis populations.
Because allocation was non-randomized, the study can describe outcomes among treated participants, but it cannot by itself provide the protection against confounding that random assignment is designed to offer. The phase I and phase II cohorts should therefore be understood as parts of a single-arm development study, not as treatment and control arms in a randomized trial.
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.
Before assignment: Participants in lead-in were included in Cohort A for outcome measure data.
Overall Study
| Stage | Phase I - Lead in | Phase II- Cohort A | Phase II - Cohort B |
|---|---|---|---|
| STARTED | 3 | 44 | 48 |
| COMPLETED | 3 | 42 | 43 |
| NOT COMPLETED | 0 | 2 | 5 |
Reasons for not completing this period:
| Reason | Phase I - Lead in | Phase II- Cohort A | Phase II - Cohort B |
|---|---|---|---|
| Death | 0 | 2 | 5 |
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 | Phase I - Lead in | Phase II - Cohort A | Phase II - Cohort B | Total |
|---|---|---|---|---|---|
| Participants analysed | 3 | 44 | 48 | 95 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 24 | 32 | 58 |
| Age, Categorical: >=65 years | Participants | 1 | 20 | 16 | 37 |
| Sex: Female, Male: Female | Participants | 1 | 7 | 15 | 23 |
| Sex: Female, Male: Male | Participants | 2 | 37 | 33 | 72 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 2 | 2 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 | 41 | 45 | 89 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 3 | 3 | 6 |
| Race (NIH/OMB): White | Participants | 3 | 39 | 42 | 84 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 2 | 3 |
| Region of Enrollment: United States | participants | 3 | 44 | 48 | 95 |
6. Primary Endpoint
The registry lists the primary outcome as Phase II: Overall Survival (OS), measured over Up to 24 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 90% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The phase II primary endpoint is overall survival (OS), expressed as a median with a 90% confidence interval. The registry defines OS as the time from treatment start until death from any cause and names evaluable participants as the population. The timeframe is listed as up to 24 months. The endpoint description refers to one-year overall survival, while the measure itself is specified as median OS; these are related but distinct ways of summarizing survival.
In general, overall survival is a time-to-event endpoint: the event is death, and the analysis uses the time until that event rather than only whether it occurred by a fixed date. A median summarizes the time by which half of the relevant survival distribution has experienced the event, subject to the analysis method and follow-up. A confidence interval expresses uncertainty around an estimate; it is not a range containing a fixed proportion of individual participants’ survival times.
OS is used because death from any cause is a direct and clearly defined event. It does not require decisions about whether a particular clinical change represents disease progression. At the same time, interpretation depends on follow-up duration, censoring, and the analysis population. The registry record does not report the median, its 90% confidence interval, the number of deaths used in the endpoint analysis, or details of censoring. It therefore does not permit a numerical interpretation of the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a phase II primary endpoint but does not provide its result. No median overall survival or 90% confidence interval is reported. There is also no reported hazard ratio or primary endpoint analysis to interpret. The central statistical conclusion is therefore limited: the registry record describes what was intended to be measured, but does not show the estimate or its precision.
The endpoint description refers to one-year OS, whereas the listed measure is median OS with a 90% confidence interval and a timeframe of up to 24 months. These summaries answer different questions. A one-year survival proportion describes the estimated probability of being alive at a stated time; a median describes the time at which the survival estimate reaches a specified point in its distribution. The record does not provide either numerical result, so neither can be evaluated.
Overall survival is a time-to-event outcome. In general, participants who have not experienced the event by the end of their observed follow-up may contribute information up to that point and then be censored. Such data require methods that account for varying follow-up. The registry record does not describe the survival estimator, censoring rules, or follow-up distribution. Without those details and the outcome estimates, the precision and robustness of the OS result cannot be assessed.
The study is non-randomized and does not identify a randomized control group. Thus, even if cohort outcome estimates were available, they would describe outcomes in the enrolled participants and would not establish a causal difference from an assigned comparator. In general, non-randomized comparisons can be affected by differences in participant characteristics, treatment pathways, or follow-up. No adjustment methods or comparator analyses are reported in the registry record.
The registry lists five outcome measures and identifies secondary outcomes including overall response rate, progression-free survival, and treatment-related adverse events. It records zero analyses. That means the registry entry does not contain statistical analyses to examine for those outcomes. It does not establish that no analyses were conducted outside the registry, nor does it justify substituting unreported outcomes for the primary endpoint.
Safety information is recorded by study group, including numbers at risk and numbers with serious or other adverse events. Those counts describe event reporting in the listed groups; they do not by themselves establish whether an event was caused by treatment. The serious-event terms and their percentages also require care because the record does not provide event-level counts or explain whether participants could contribute more than one event. A percentage alone should not be read as an incidence comparison between treatments.
Overall, the posted registry information supports a description of the study’s design, endpoint, and some safety counts, but not an estimate of the primary outcome or a treatment-effect conclusion. The absence of a reported analysis is a limit on what can be inferred from this record, not evidence that the endpoint had a particular value.
9. Statistical Methods Explained
Several statistical ideas help frame the registry entry, but the specific analysis methods used by the investigators are not reported in the registry record. The following explanations describe general concepts rather than asserting that a particular method was used in this study.
What does a median survival time represent?
Overall survival records the time from treatment start until death from any cause. In time-to-event analysis, the median is the time at which the estimated survival distribution reaches the halfway point. It is a summary of the distribution, not the expected survival time for every participant and not a statement about an individual’s outcome. If the survival estimate does not reach that point during available follow-up, a median may not be estimable; whether that occurred in this study is not reported in the registry record.
Time-to-event data can include participants whose event has not occurred by the end of their observation. General survival methods can use their observed follow-up without treating them as if they had died at the end of that period. This requires censoring assumptions and a clearly defined analysis. The registry record does not report the censoring rules or the method used to estimate OS.
How should a confidence interval be read?
A confidence interval communicates uncertainty around an estimated quantity. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. It does not describe the spread of individual survival times. The registry specifies a 90% confidence interval for the primary endpoint, but does not report the interval limits or the method used to calculate it. Therefore, the stated confidence level alone cannot show how precise the estimate was.
The registry describes the endpoint as median OS and also refers to one-year OS in the endpoint description. These are not interchangeable summaries. A survival probability at a fixed time focuses on the estimated proportion still alive at that time; a median focuses on the time corresponding to the midpoint of the survival distribution. Neither numerical summary is present in the registry record.
What can a non-randomized design establish?
Randomization is a design method intended to make treatment groups comparable on average with respect to measured and unmeasured characteristics. This study is listed as non-randomized and no control group is identified. Its cohorts can be described, but they should not be interpreted as randomized treatment comparisons. General statistical adjustment can address some measured differences in some settings, but it cannot automatically remove all confounding. The registry record does not report adjusted comparisons or the methods used to account for participant differences.
The phase I and phase II components also have different roles in a development program. In general, dose escalation is used to explore dosing, while a phase II component evaluates outcomes at a selected dose. This broad distinction does not reveal the actual dose-escalation algorithm or decision thresholds used. Those details are not reported in the registry record. The available arm descriptions identify cetuximab dose escalation in phase I and the recommended phase II dose in phase II, without complete phase I dosing information.
What do planning sample sizes mean?
Sample-size planning illustrations are not observed trial outcomes and are not a measure of observed power. General planning calculations depend on assumptions about the effect to detect, significance level, allocation, and statistical model. The registry record does not report the trial’s own sample-size justification or design assumptions. Any planning illustration based on an observed effect is conditional on that effect and on the stated assumptions; it does not show that the trial had a given probability of finding a result after the fact.
For time-to-event outcomes, planning often concerns the number of events needed under specified assumptions, rather than only the number enrolled. Follow-up and the timing of events matter to the information available. The number enrolled alone does not establish the precision of a survival estimate. The registry record does not report the primary endpoint event count or the assumptions used to plan the study.
Why does over-dispersion matter in general?
Over-dispersion occurs when observed variability is greater than a model assumes. If a model does not account for that extra variation, standard errors may be too small and confidence intervals too narrow. This is a general concern for some count outcomes; it should not be taken to mean that over-dispersion was present or that a count model was used in this study. The registry record does not report model diagnostics or a statistical plan for count outcomes.
What can be inferred from the analysis record?
The registry lists five outcome measures and zero analyses. No sponsor-reported hazard ratios or primary outcome estimates are available in this record. General recalculations from summary statistics, when available, would be unadjusted and would not replace an analysis specified by the sponsor. There are no such posted primary endpoint summary statistics to recalculate. The record does not report interim analyses, multiplicity procedures, missing-data methods, or the handling of participants who were not evaluable.
These distinctions separate the endpoint that was registered from the analysis needed to estimate it. Knowing that OS was the primary endpoint does not reveal the result, its precision, the analysis population actually used, or whether an analysis followed a prespecified plan. Those items are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies OS as the phase II primary endpoint and lists secondary outcomes of overall response rate, progression-free survival, and treatment-related adverse events. It lists five outcome measures overall and records zero analyses. The registry record does not report how many statistical hypotheses were tested, whether any multiplicity adjustment was planned, or which outcomes were intended to support formal claims.
In general, multiplicity arises when several outcomes, comparisons, time points, or subgroups are examined. Without a prespecified strategy, repeated testing can increase the chance of an apparently notable result arising by chance. This general concern does not establish that the study used an inappropriate strategy; the relevant plan is not reported in the registry record.
The endpoint population is described as evaluable participants, but the registry does not define evaluability or report the number included in the OS analysis. It also does not describe missing-data procedures, censoring rules, or how participants with incomplete follow-up were handled. For a time-to-event endpoint, loss of follow-up and censoring assumptions can affect interpretation. The record does not provide enough information to assess those issues.
The registry also does not report interim analyses, subgroup analyses, a statistical analysis plan, or a sample-size justification. Their absence from the registry entry should be read as missing reporting in that record, not proof that no such work occurred elsewhere. With no posted endpoint analyses, there is no basis to assess multiplicity control or analysis-population sensitivity.
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 |
|---|---|---|---|
| Phase I - Lead in | 3 | 3 | 100.0% |
| Phase II- Cohort A | 19 | 44 | 43.2% |
| Phase II - Cohort B | 19 | 48 | 39.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Phase I - Lead in | 2 of 3 |
| Phase II- Cohort A | 35 of 44 |
| Phase II - Cohort B | 33 of 48 |
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 |
|---|---|
| Phase I - Lead in | 3 of 3 |
| Phase II- Cohort A | 43 of 44 |
| Phase II - Cohort B | 45 of 48 |
Most frequent serious adverse event terms
| Event term | Organ system | Phase I - Lead in | Phase II- Cohort A | Phase II - Cohort B |
|---|---|---|---|---|
| Aspiration | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 5 of 44 | 7 of 48 |
| Neoplasms benign, malignant and unspecified-Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 3 | 6 of 44 | 3 of 48 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 5 of 44 | 1 of 48 |
| Sepsis | Infections and infestations | 0 of 3 | 2 of 44 | 2 of 48 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 1 of 44 | 3 of 48 |
| Vomiting | Gastrointestinal disorders | 0 of 3 | 0 of 44 | 3 of 48 |
| Pericardial effusion | Cardiac disorders | 0 of 3 | 0 of 44 | 3 of 48 |
| Death, NOS | General disorders | 0 of 3 | 2 of 44 | 0 of 48 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 2 of 44 | 0 of 48 |
| Atrial fibrilation | Cardiac disorders | 0 of 3 | 1 of 44 | 1 of 48 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Phase I - Lead in | Phase II- Cohort A | Phase II - Cohort B |
|---|---|---|---|---|
| Rash acneiform | Skin and subcutaneous tissue disorders | 3 of 3 | 21 of 44 | 31 of 48 |
| Fatigue | General disorders | 2 of 3 | 17 of 44 | 15 of 48 |
| Dry Skin | Skin and subcutaneous tissue disorders | 1 of 3 | 9 of 44 | 23 of 48 |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | 0 of 3 | 9 of 44 | 19 of 48 |
| Hypomagnesemia | Metabolism and nutrition disorders | 1 of 3 | 8 of 44 | 16 of 48 |
| Constipation | Gastrointestinal disorders | 0 of 3 | 16 of 44 | 7 of 48 |
| Hypophosphatemia | Metabolism and nutrition disorders | 2 of 3 | 7 of 44 | 14 of 48 |
| Anemia | Blood and lymphatic system disorders | 2 of 3 | 5 of 44 | 14 of 48 |
| Diarrhea | Gastrointestinal disorders | 1 of 3 | 8 of 44 | 12 of 48 |
| Nausea | Gastrointestinal disorders | 1 of 3 | 9 of 44 | 11 of 48 |
Serious events with the highest arm-level rate: skin infection (33.3%), fall (33.3%), back pain (33.3%), anemia (33.3%), fatigue (33.3%).
The safety entries are grouped as Phase I - Lead in, Phase II- Cohort A, and Phase II - Cohort B. The numbers at risk for serious and other adverse events are 3, 44, and 48, respectively. The corresponding numbers with serious adverse events are 3, 19, and 19; the numbers with other adverse events are 3, 43, and 45. The recorded deaths are 2, 35, and 33, respectively. These are descriptive counts for the listed groups, not a randomized comparison.
The registry lists Skin infection, Fall, Back pain, Anemia, Fatigue, and Sinus tachycardia as serious adverse event terms, each with a reported percentage of 33.3%. The record does not provide event-level counts for these terms or explain whether a participant could have more than one event. The percentages should therefore be read as reported term frequencies, not as evidence about relative risk or treatment causation.
General safety interpretation also depends on how events were defined, collected, graded, and attributed, as well as duration of exposure and follow-up. Those details are not reported in the registry record. A count of participants with an event is not the same as a count of events, and a serious adverse event is not necessarily treatment-related. The registry separately lists treatment-related adverse events as a secondary outcome, but does not report its analysis.
Because the study is non-randomized, these group counts cannot establish that one cohort had more or fewer events because of treatment. The figures describe what the registry records for each group and do not support a controlled safety comparison.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, non-randomized phase I/II study evaluated concurrent cetuximab and nivolumab in recurrent and/or metastatic HNSCC. It identifies phase II median OS as the primary endpoint, specifies a 90% confidence interval, and names evaluable participants as the population. It also records safety counts for three groups and lists secondary outcomes.
Those details do not establish the numerical OS result. The median, its confidence interval, and any hazard ratio are not reported in the registry record. The registry also does not report analyses for the listed outcome measures. Without those results, the primary endpoint’s magnitude and precision cannot be assessed from this entry.
Even if outcome estimates were available, the non-randomized design would limit causal interpretation. The study does not identify a randomized comparator, so observed outcomes would describe the enrolled participants rather than show what would have happened to comparable participants under another assigned treatment. Cohort differences cannot be interpreted as treatment effects without appropriate design and analysis, and no such comparative analysis is reported.
The safety counts can describe the recorded number of participants with serious or other adverse events in the listed groups. They cannot, on their own, establish that treatment caused an event or support a controlled comparison. The listed serious-event terms and percentages likewise do not supply event-level context or a causal analysis.
Accordingly, the registry supports a description of the research question, design, endpoint, and some recorded safety information. It does not support a conclusion about the size, direction, or precision of the primary survival outcome, nor a conclusion that the combination did or did not produce a clinical benefit. Those judgments require outcome analyses and context not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable for the difference between a registered endpoint and a reported result. The record gives a clear primary endpoint framework—phase II median overall survival, a 90% confidence interval, and an evaluable-participant population—but does not give the estimate or its interval. This distinction is important: an endpoint definition describes what investigators intended to measure, while an analysis is needed to show what the data estimated.
The non-randomized design is another central statistical feature. It is suitable for describing outcomes in the study cohorts, but it does not create a randomized control comparison. Readers should not interpret the phase I and phase II groups as if treatment had been assigned at random between comparable arms. Design determines which comparisons can be interpreted, regardless of how precisely an outcome might be estimated.
The record also illustrates why time-to-event outcomes require more than an enrollment count. OS depends on event times, follow-up, and censoring. The registry does not report the primary endpoint event count, survival estimate, or analysis methods, so enrollment of 95 alone cannot establish the endpoint’s precision.
Finally, the safety figures call for careful distinction between participant counts, event terms, and causality. Serious and other adverse events are recorded by cohort, but no randomized comparison or detailed event analysis is reported. The statistical value of the record is therefore chiefly descriptive: it identifies the study structure and the intended outcome, while leaving the primary outcome analysis 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 main limitation for statistical interpretation is that the registry record does not report the primary OS result. It gives no median, 90% confidence interval limits, hazard ratio, or primary endpoint analysis. The stated endpoint population is evaluable participants, but the number included and the definition of evaluability are not reported.
The design is non-randomized and no control group is identified. This prevents a like-for-like randomized comparison and limits causal interpretation of cohort outcomes. The registry record does not describe how participants entered cohorts or whether analyses adjusted for differences among them.
Important survival-analysis details are not reported, including the censoring rules, analysis method, follow-up distribution, and primary endpoint event count. The endpoint description refers to one-year OS, while the listed measure is median OS; neither numerical summary is available to resolve how the outcome was reported.
The registry identifies five outcome measures but records zero analyses. It does not report a statistical analysis plan, multiplicity procedures, missing-data methods, interim analyses, or the trial’s sample-size justification. Safety reporting includes group counts and selected serious-event terms, but event-level detail, collection methods, grading, and treatment attribution are not reported.
These are limitations of the information available in the registry record. They do not establish that the study lacked analyses or methods outside the registry, and they do not permit reconstruction of unreported results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma — NCT03370276.
- Registry record last updated 2026-04-02; status last verified 2026-03.
- Results first posted 2022-12-20.
- 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
NCT03370276 is a completed, phase I/II, non-randomized, parallel study with no masking. It evaluated concurrent cetuximab and nivolumab in recurrent and/or metastatic HNSCC and lists enrollment of 95. The phase I component involved cetuximab dose escalation; the phase II component used cetuximab at the recommended phase II dose with nivolumab.
The phase II primary endpoint is median overall survival with a 90% confidence interval, in evaluable participants, over a timeframe listed as up to 24 months. The endpoint description also refers to one-year OS. Secondary outcomes include overall response rate, progression-free survival, and treatment-related adverse events.
The registry record does not report the primary endpoint estimate or analyses for the listed outcomes. It includes safety counts by group and selected serious adverse event terms. Because the study is non-randomized and does not identify a control group, the cohort figures do not constitute a randomized treatment comparison.