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 Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma (NCT06046482), a randomized phase 2 study. The primary outcome is Objective Response Rate (ORR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06046482 |
| Phase | Phase 2 |
| Condition | Head Neck, Squamous Cell Carcinoma of Head and Neck |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with recurrent or metastatic head and neck squamous cell carcinoma. The registry lists the conditions as Head Neck and Squamous Cell Carcinoma of Head and Neck. The record does not provide further eligibility details or a more specific description of the participants in the primary outcome population; those details are not reported in the registry record.
Intervention
Both cohorts were assigned magrolimab and cetuximab alongside another drug. Cohort A was described as receiving pembrolizumab with the combination; Cohort B was described as receiving docetaxel with the combination. The registry names all four drugs as interventions.
Comparator
The two described cohorts differ in whether pembrolizumab or docetaxel accompanies magrolimab and cetuximab. The record identifies randomized allocation, but also identifies the model as single group and provides no further account of the randomization or the intended comparison. The exact comparison structure is therefore not clear from the registry record.
Primary question
The primary outcome is objective response rate assessed per RECIST v1.1 at 140 days. It classifies target-lesion response using CT or MRI as complete response, partial response, stable disease, or progressive disease. The record does not provide a single numerical response result or a statistical comparison between the cohorts. The question can be described from the outcome definition, but an estimate of response or a comparative treatment effect cannot be interpreted from this record.
3. Trial Design
This is listed as a phase II trial of magrolimab and cetuximab with either pembrolizumab or docetaxel for recurrent or metastatic head and neck squamous cell carcinoma. The registry identifies the allocation as randomized and masking as none. It also lists the model as single group, while separately describing Cohort A and Cohort B. Those entries do not establish a clear statistical comparison structure, and the record does not explain how participants were allocated between the cohorts.
Cohort A is described as receiving magrolimab and cetuximab with pembrolizumab. Cohort B is described as receiving magrolimab and cetuximab with docetaxel. The registry records enrollment of 4 and lists the study status as terminated. The recorded start date is 2023-11-28, and the primary completion date is 2024-08-26. The reason for termination and details of the study's conduct are not reported in the registry record.
The primary outcome is objective response rate, with a 140 days timeframe. Secondary outcomes include treatment-emergent adverse events graded using NCI CTCAE v5.0, duration of response, and participants with progression-free survival and/or death. The record lists four outcome measures, but does not give a fuller account of their analysis populations, assessment schedule, or statistical methods. A protocol description, sample-size justification, and prespecified analysis plan are not reported in the registry record.
The combination of a randomized allocation label, a single-group model label, and two described cohorts warrants caution. These fields alone do not show whether the intended design was a randomized comparison, a single-arm study with cohorts, or another arrangement. Interpretations should follow the information explicitly recorded rather than assume a design that the registry does not clarify.
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 | Cohort A | Cohort B |
|---|---|---|
| STARTED | 1 | 3 |
| COMPLETED | 1 | 3 |
| NOT COMPLETED | 0 | 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 | Cohort A | Cohort B | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 3 | 4 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 2 | 2 |
| Age, Categorical: >=65 years | Participants | 1 | 1 | 2 |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 1 | 3 | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | 3 | 4 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 1 | 3 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Objective Response Rate (ORR), measured over 140 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
Objective response rate (ORR) is the primary outcome. The registry defines response using RECIST v1.1 for target lesions assessed by CT or MRI. Complete response means disappearance of all target lesions. Partial response requires at least a 30% decrease in the sum of the longest diameters of target lesions. Stable disease is neither enough shrinkage for partial response nor enough growth for progressive disease. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters, with an absolute increase of at least 5 mm, or the appearance of new lesions.
In general, ORR describes the frequency of participants classified as having a complete or partial response under the stated criteria. It is used to summarize tumor response, while the RECIST categories distinguish response from stable or progressive disease. The registry specifies the primary outcome unit as participants and the parameter as a count of participants. It does not provide a numerical ORR result, a breakdown of the response categories, or a comparison between Cohort A and Cohort B. The stated assessment timeframe is 140 days; further details about assessment timing are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record does not provide a numerical primary response result that can be interpreted as an estimate of ORR. It also does not provide a confidence interval, a hypothesis test, or a direct comparison between the two described cohorts. The primary outcome is defined using several response categories, and the available record does not reduce those categories and time points to one comparison. As a result, no conclusion about the magnitude or precision of a response estimate can be drawn from the primary outcome information in this record.
The recorded enrollment is 4. That total is a limited basis for describing outcomes, and the safety counts are likewise sparse. Counts from a small observed group can change substantially with the experience of an individual participant. In general, a confidence interval expresses uncertainty around an estimate; no interval for ORR is reported in the registry record. Without an estimate and its uncertainty, the outcome cannot be assessed for precision or compared statistically across cohorts.
The registry describes two treatment cohorts, but its design fields are not fully aligned: allocation is listed as randomized, while the model is listed as single group. The descriptions do not provide enough detail to resolve that tension. In addition, the record says the study was terminated, but does not state why. These limitations mean that the cohort descriptions should not be treated as proof of a particular randomized comparison or of the reasons for stopping.
Safety entries show that serious adverse events were recorded among the participants in the cohorts, while no deaths are listed in either cohort. The entries are counts, not estimates of comparative risk. The serious-event counts are based on 1 participant at risk in Cohort A and 3 in Cohort B, so they cannot support a stable comparison. The registry lists Colitis at 33.3% among the top serious terms, but the record does not give enough context to infer a causal relationship or to generalize that figure.
Overall, the posted information supports a description of the study's stated purpose, cohorts, outcomes, and a few event counts. It does not support a quantitative conclusion about response, comparative efficacy, or the relative safety of the cohort regimens. Missing statistical details and the absence of a reported primary outcome estimate further limit interpretation.
9. Statistical Methods Explained
Statistical methods describe how investigators turn participant observations into estimates and how they quantify uncertainty. The registry record gives the primary outcome definition and several design labels, but it does not report a complete statistical analysis plan. The distinctions below help separate what the outcome means from what can be concluded using the available record.
What does the primary outcome count?
The primary outcome is objective response rate per RECIST v1.1, recorded as a count of participants, with a timeframe of 140 days. RECIST classifies target-lesion findings assessed using CT or MRI. Complete and partial response are response categories; stable and progressive disease are separate categories. In general, a rate summarizes the share of an analyzed group in specified response categories. A count alone is not a rate unless the relevant denominator and analysis population are also defined. The record supplies neither a numerical primary count nor a primary denominator, so an ORR cannot be reconstructed from the posted information.
What would a comparison require?
A comparison would need a clearly stated estimand: the outcome being compared, the groups included, the time point, and the way participants are handled in the analysis. Here, the two cohort descriptions distinguish pembrolizumab from docetaxel as the additional drug. However, the registry also labels the model single group, while labeling allocation randomized. It does not explain how these entries relate or specify a primary cohort contrast. Consequently, the comparative question is not sufficiently defined in the record to identify an analysis or interpret a treatment-effect estimate.
In general, randomization can support comparisons by distributing known and unknown baseline factors across groups, but the registry's allocation label alone does not give details of the procedure or analysis. Masking is listed as none. The record does not report whether outcome assessment had safeguards against knowledge of cohort assignment, nor does it describe any adjustment for baseline characteristics. No adjusted or unadjusted primary analysis is reported in the registry record.
How should uncertainty be understood?
In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of the analysis. Its width reflects precision, and its interpretation depends on the model and data. No primary estimate or confidence interval is reported. With enrollment recorded as 4, even a descriptive outcome count would be based on very few observations. The posted record does not provide enough information to assess uncertainty in ORR or to determine whether any difference between cohorts is distinguishable from random variation.
In general, a hypothesis test evaluates data against a specified null hypothesis, using a prespecified analysis and significance threshold. The registry does not report a primary hypothesis test, p-value, or statistical comparison. It is therefore not possible to treat the lack of a reported test as evidence for either similarity or difference. The registry record does not report an interim analysis plan or stopping rule.
What do the planning assumptions mean?
The planning illustration is described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. These are assumptions for planning illustrations, not evidence of the trial's original design or its observed performance. The record does not report the protocol's sample-size justification. Any sample-size outputs should be read as planning illustrations rather than observed power, and should not be taken as an account of the trial's planned enrollment unless that is separately documented.
In general, over-dispersion means that observed variability exceeds what a model assumes. It matters because a model that understates variability can give misleading uncertainty estimates. The registry does not report a dispersion estimate or a model addressing over-dispersion. Since the primary outcome is presented as a participant count and no inferential analysis is reported, there is no basis in this record to evaluate such a model choice.
What analyses are available in the record?
The registry record contains no analysis entries. It also does not report the analysis population, handling of participants who did not complete assessments, missing outcome data, or a method for addressing incomplete follow-up. Those omissions prevent assessment of whether an analysis would use all randomized participants, participants who received treatment, or another defined group. They also prevent checking whether the outcome definition and analysis population align.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome and secondary outcomes that include treatment-emergent adverse events, duration of response, and progression-free survival and/or death. It does not report how testing across multiple outcomes, cohorts, response categories, or assessment times would be handled. A multiplicity adjustment or a hierarchy of hypotheses is not reported in the registry record.
In general, testing many outcomes or comparisons can increase the chance of obtaining an apparently notable finding by chance. Prespecified rules for which outcomes are confirmatory and how comparisons are controlled help readers interpret that risk. The outcome information available does not specify such rules, so no multiplicity-adjusted interpretation can be made.
The record does not describe missing-data handling, reasons for missing assessments, or the number of participants contributing to each outcome. It also does not define the primary analysis population or state how discontinuation, incomplete follow-up, or unevaluable response assessments would be treated. Those items are not reported in the registry record.
These omissions matter because the primary outcome depends on imaging assessments and a stated time frame, and because the recorded enrollment is 4. Without participant-level disposition and analysis-population details, the relationship between enrollment and outcome counts cannot be checked. No conclusion about the direction or impact of missing data is possible from this 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 |
|---|---|---|---|
| Cohort A | 0 | 1 | 0.0% |
| Cohort B | 1 | 3 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort A | 0 of 1 |
| Cohort B | 0 of 3 |
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 |
|---|---|
| Cohort A | 1 of 1 |
| Cohort B | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort A | Cohort B |
|---|---|---|---|
| Colitis | Gastrointestinal disorders | 0 of 1 | 1 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort A | Cohort B |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 1 of 1 | 3 of 3 |
| Mucositis oral | Gastrointestinal disorders | 1 of 1 | 3 of 3 |
| Rash Acneiform | Skin and subcutaneous tissue disorders | 1 of 1 | 3 of 3 |
| Hyponatremia | Metabolism and nutrition disorders | 1 of 1 | 2 of 3 |
| White blood cell decreased | Investigations | 1 of 1 | 2 of 3 |
| Abdominal Pain | Gastrointestinal disorders | 0 of 1 | 2 of 3 |
| Alanine aminotransferase increased | Investigations | 1 of 1 | 1 of 3 |
| Alkaline phosphatase increased | Investigations | 1 of 1 | 1 of 3 |
| Aspartate aminotransferase increased | Investigations | 1 of 1 | 1 of 3 |
| Constipation | Gastrointestinal disorders | 1 of 1 | 1 of 3 |
Serious events with the highest arm-level rate: colitis (33.3%).
The serious adverse event entries are reported by cohort as numbers of participants at risk and numbers affected. Cohort A lists 1 participant at risk and 0 affected; Cohort B lists 3 at risk and 1 affected. Deaths are listed as 0 for each cohort. Other adverse-event entries list 1 participant at risk and 1 affected in Cohort A, and 3 at risk and 3 affected in Cohort B.
The registry lists Colitis at 33.3% among the top serious terms. This figure should be read alongside the limited cohort counts and the registry's brief reporting. The record does not provide further details about event timing, duration, severity beyond the serious-event classification, or attribution to a particular drug. It also does not report a comparative safety analysis. These entries describe reported events in the recorded groups; they are not by themselves estimates of comparative risk or evidence that an event was caused by a treatment.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II study was registered to examine magrolimab and cetuximab with pembrolizumab or docetaxel in recurrent or metastatic head and neck squamous cell carcinoma. It describes two cohorts and names objective response rate as the primary outcome, assessed per RECIST v1.1 within a 140 days timeframe. The study status is terminated and recorded enrollment is 4.
Those details do not establish a response benefit or lack of benefit. The registry record does not report a numerical primary response result, an ORR estimate, uncertainty around an estimate, or a comparison of the cohorts. It also does not resolve the design labels that identify both randomized allocation and a single-group model. No treatment effect can be inferred from the cohort descriptions alone.
The safety entries document serious and other adverse events among the recorded participants, as well as zero deaths listed in each cohort. Because the participant counts are limited and no comparative analysis is reported, these observations cannot establish relative safety. The listed serious-event term Colitis should not be interpreted as proof of a treatment-related cause.
In general, a trial result must be interpreted in light of its population, design, endpoint, analysis methods, and uncertainty. Several of those details are not reported in the registry record. The status of terminated does not itself explain why the study ended, and the record does not state the reason. The information supports a cautious account of what was planned and what event counts were posted, but not a conclusion about treatment efficacy, comparative effects, or broad applicability.
13. Why This Trial Matters Statistically
This record illustrates why statistical interpretation depends on more than an outcome label. Objective response rate is a recognizable clinical endpoint, but a usable estimate also requires a reported numerator, denominator, assessment population, and a clear time point. The registry defines response categories and a 140 days timeframe, yet does not provide a numerical primary result. Readers therefore cannot quantify the response experience from the primary outcome entry.
The design labels also matter. A randomized allocation label and a single-group model label appear alongside descriptions of two cohorts. Without an explanation of that structure, the intended contrast is uncertain. A statistical comparison depends on knowing which groups were compared and how assignment and analysis were conducted; the cohort descriptions alone do not settle those questions.
The recorded enrollment of 4 makes the scale of the available safety counts important. Event counts can be described, but they should not be mistaken for stable estimates of risk or for a comparative safety result. The registry also gives no primary confidence interval or inferential analysis to communicate uncertainty.
Finally, the terminated status and absent analysis details show the value of transparent reporting. A record that states why a study ended, how missing outcomes were handled, and which analysis population was used would help distinguish study conduct from outcome interpretation. In this case, those details are not reported in the registry record, so conclusions must remain closely bounded by the information that is recorded.
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 that the registry record does not report a numerical result for the primary outcome. Although ORR is defined using RECIST v1.1 and a 140 days timeframe, there is no reported count breakdown, denominator, estimate, or confidence interval. The primary response information therefore cannot support a quantitative outcome interpretation.
Design details are also incomplete. The record describes Cohort A and Cohort B, identifies allocation as randomized, and identifies the model as single group, without explaining how these descriptions fit together. It does not provide randomization procedures, detailed eligibility criteria, baseline characteristics, or a primary cohort comparison. The reason for termination is not reported in the registry record.
The enrollment is recorded as 4, limiting the descriptive scope of the reported event counts. The safety entries do not provide detailed event timing, attribution, or a comparative analysis. The registry does not report the primary analysis population, missing-data handling, sample-size justification, interim analyses, or the statistical plan. These gaps limit assessment of precision, potential bias, and generalizability.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma — NCT06046482.
- Registry record last updated 2025-10-22; status last verified 2025-10.
- Results first posted 2025-10-22.
- 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
The registry record describes a phase II study of magrolimab and cetuximab with pembrolizumab or docetaxel for recurrent or metastatic head and neck squamous cell carcinoma. It lists randomized allocation, no masking, a single-group model, enrollment of 4, and a terminated status. Cohort A is described with pembrolizumab and Cohort B with docetaxel.
The primary outcome is objective response rate per RECIST v1.1 at 140 days, assessed with CT or MRI. Secondary outcomes include treatment-emergent adverse events, duration of response, and progression-free survival and/or death. The record includes limited adverse-event counts, but no numerical primary response result or analysis entries. The reason for termination, sample-size justification, analysis populations, missing-data methods, and statistical plan are not reported in the registry record.