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 Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer (NCT02853604), a randomized phase 3 study. The primary outcome is Disease Free Survival (DFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02853604 |
| Phase | Phase 3 |
| Condition | High Risk Cervical Cancer, Advanced Cervical Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 110 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Advaxis, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with high-risk locally advanced cervical cancer following cisplatin-based combination chemotherapy and radiation therapy with curative intent. The registry describes this group as being at higher risk for recurrence.
Intervention
ADXS11-001 administered after chemoradiation. The arm description specifies intravenous infusion, with an initial schedule every 3 weeks for 3 doses and subsequent doses every 8 weeks.
Comparator
Matching placebo administered after chemoradiation. The registry describes an intravenous infusion schedule corresponding to the ADXS11-001 schedule.
Primary question
Would disease-free survival, defined as time from randomization until recurrence or death, differ between the ADXS11-001 and placebo groups? The registry record states that the endpoint was not reported because the study was terminated early for business reasons and no efficacy data were collected.
The study was intended to examine adjuvant treatment after chemoradiation, rather than treatment during the initial chemoradiation course. Its stated purpose was to compare disease-free survival in participants with high-risk locally advanced cervical cancer. The registry’s background summary describes an estimated probability of recurrence or death within 4 years of diagnosis of 50%; this is background context, not an outcome measured in this trial.
The record identifies the study as randomized, quadruple-masked, and parallel-group. It lists ADXS11-001 and placebo as the interventions. However, the efficacy comparison needed to address the clinical question is unavailable: the primary endpoint was not reported, and the record explicitly says no efficacy data were collected. Consequently, the intended question remains unanswered by the posted trial results.
3. Trial Design
The registry describes a randomized, quadruple-masked, parallel-group Phase 3 study of ADXS11-001 versus placebo. Both study treatments were intended to follow cisplatin-based combination chemotherapy and radiation therapy given with curative intent. The stated enrollment was 110. The record lists the study start as 2015-12-15 and primary completion as 2019-07-31; its overall status is terminated.
The intervention descriptions specify intravenous infusions. ADXS11-001 was described at a dose of 1x10^9 colony forming units (CFU), with infusions approximately 60 minutes long, initially every 3 weeks for 3 doses and thereafter every 8 weeks for 5 doses. The placebo description gives the same infusion duration and schedule. The available ADXS11-001 arm description is truncated after referring to treatment until disease-related circumstances, so the complete stopping instructions are not reported in the registry record.
Randomization indicates that assignment was intended to be made using a chance-based process, but the specific method for generating or concealing the allocation is not reported in the registry record. The record labels masking as quadruple, but does not identify which groups of people were masked or explain how masking was maintained. The planned allocation ratio is not reported in the registry record.
The study was terminated early due to business reasons. The registry explicitly states that no efficacy data were collected and that disease-free survival was not reported. Thus, although the design was intended to support a comparison between treatment groups, the posted record does not contain the primary outcome results required to evaluate that comparison.
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 completed cisplatin-based combination chemotherapy and radiation (CCRT) before enrollment into the study.
Overall Study
| Stage | Placebo | ADXS11-001 |
|---|---|---|
| STARTED | 37 | 73 |
| Treated | 37 | 72 |
| COMPLETED | 9 | 21 |
| NOT COMPLETED | 28 | 52 |
Reasons for not completing this period:
| Reason | Placebo | ADXS11-001 |
|---|---|---|
| Withdrawal by Subject | 12 | 35 |
| Lost to Follow-up | 4 | 8 |
| Death | 1 | 5 |
| Miscellaneous | 11 | 2 |
| Progressive Disease | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: This endpoint was not reported as the study was terminated early due to business reasons, therefore, no efficacy data was collected.
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.
Population: The As Treated (AT) Population included all participants who received any dose of the study treatment.
| Characteristic | Unit | Placebo | ADXS11-001 | Total |
|---|---|---|---|---|
| Participants analysed | 37 | 72 | 109 | |
| Age, Continuous | years | 46.0 (SD 10.34) | 49.3 (SD 10.61) | 48.2 (SD 10.59) |
| Sex: Female, Male: Female | Participants | 37 | 72 | 109 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 8 | 15 | 23 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 28 | 57 | 85 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 2 | 9 | 11 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 2 | 5 |
| Race (NIH/OMB): White | Participants | 30 | 53 | 83 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 7 | 9 |
6. Primary Endpoint
The registry lists the primary outcome as Disease Free Survival (DFS), measured over From the time of randomization to recurrence or death (Maximum duration: 44.7 months).
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was disease-free survival (DFS), defined as the time from randomization until recurrence or death. It is a time-to-event measure: the outcome depends both on whether a participant experiences an event and on the time at which it occurs. The registry’s timeframe describes follow-up from randomization to recurrence or death, with a maximum duration of 44.7 months.
The record defines recurrence as the first time point at which disease recurrence was determined. Recurrence was to be confirmed by definitive pathologic tissue evidence, such as biopsy or fine needle aspirate. If obtaining tissue was not medically feasible, radiographic evidence confirmed by independent radiology review could be used. The record does not provide observed DFS times, event counts for this endpoint, or a treatment-effect estimate.
In general, DFS is used in cancer studies to capture recurrence or death within a single time-to-event outcome. It can therefore reflect more than one type of event, and its interpretation depends on the endpoint definition, follow-up, and the analysis plan. Here, the endpoint is clearly defined in the registry, but the study’s early termination means that no efficacy data were collected. The posted record therefore cannot show how DFS compared between ADXS11-001 and placebo.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical finding is the absence of an efficacy result. The registry states that the study was terminated early due to business reasons and that no efficacy data were collected. It consequently does not report the primary DFS endpoint. There is no posted treatment-effect estimate, confidence interval, or efficacy test result to interpret.
This is not evidence that the treatment groups had the same DFS, nor is it evidence that one group had better DFS. A comparison requires observed outcome information from the groups. Without those data, the direction and size of any difference are unknown, and the precision of an estimate cannot be assessed. In particular, no conclusion about a clinically meaningful benefit or lack of benefit can be drawn from the missing endpoint.
The registry record does report adverse-event information. It lists serious adverse events for the placebo group as 3 affected among 37 participants at risk, and for the ADXS11-001 group as 10 affected among 72 at risk. It also lists other adverse events and deaths. These are descriptive safety counts, not substitutes for the missing DFS comparison. The record does not provide an efficacy analysis relating these safety figures to disease-free survival.
The registry lists enrollment as 110, but enrollment alone does not establish how much information was available for the primary endpoint. For a time-to-event outcome, interpretation depends on observed events and follow-up, not simply on the enrollment figure. Because the primary outcome was not reported, neither the event experience nor the resulting statistical precision can be assessed from this record.
The registry indicates no recorded analyses. It does not report an analysis population, a statistical model for DFS, or an inferential result. The study’s stated purpose and design identify the intended comparison, but the record cannot answer that question. The defensible interpretation is therefore limited: the registry documents the trial design, early termination, and some adverse-event counts, while the primary efficacy outcome remains unavailable.
9. Statistical Methods Explained
What would a time-to-event analysis describe?
DFS is a time-to-event endpoint. In general, a time-to-event analysis uses information about both the timing of an event and whether the event was observed during follow-up. It can also account for participants whose event has not been observed by the time their available follow-up ends. Such participants are commonly described as censored: their observed time contributes information up to the point follow-up ends, but their later outcome is unknown. This is a general explanation, not a description of an analysis reported for this study.
The registry defines the event as recurrence or death and gives rules for determining recurrence. It does not report the number of DFS events, the follow-up distribution, censoring information, or an estimated DFS curve. As a result, readers cannot evaluate how much event information would have supported an efficacy analysis or how follow-up differed between groups.
What would a treatment-effect estimate and confidence interval convey?
In general, an effect estimate expresses the observed contrast between treatment groups according to a chosen statistical measure. A confidence interval describes the uncertainty around that estimate under the assumptions of the analysis. A narrower interval indicates greater statistical precision, while a wider interval indicates greater uncertainty. Neither an estimate nor its interval is reported for DFS in this registry record. There is therefore no value to interpret for the magnitude, direction, or precision of the primary comparison.
A confidence interval is not a guarantee that the true effect lies within its limits. It is a statistical summary whose interpretation depends on the model and data. This general distinction matters because a missing result cannot be treated as an estimate centered at no difference, and it cannot be interpreted as a precise null finding. In this study, the record says the endpoint was not reported and no efficacy data were collected.
What can a significance test establish?
In general, a significance test evaluates how compatible the observed data are with a specified null hypothesis under the test’s assumptions. A p-value does not describe the size or importance of an effect, and it cannot replace an effect estimate with an interval. No DFS test result or p-value is reported in the registry record. The record also does not report the statistical analysis plan, including the test or model intended for the primary endpoint.
Randomization can support a fair comparison by balancing factors in expectation, but it does not itself supply an outcome result. The registry identifies the allocation as randomized without reporting its sequence-generation method or allocation concealment. The study is labelled quadruple-masked, but the masked roles and operational details are not reported. These design labels are informative, but they do not allow reconstruction of the missing efficacy analysis.
How should planning assumptions be understood?
In general, sample-size calculations are planning exercises based on assumptions about the effect to detect, the variability or event process, the allocation, and the significance level. The registry’s planning description specifies a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It also describes planning illustrations based on fractions of an observed effect. These are planning assumptions, not observed trial results and not a measure of the trial’s observed power.
The primary DFS outcome has no reported observed effect in this record. Therefore, no endpoint-based observed effect can be evaluated from the posted results, and a planning illustration tied to an observed effect cannot replace the missing clinical comparison. The registry does not report the trial’s own sample-size justification or the assumptions used in its original design. Whether any interim efficacy analyses were planned or performed is not reported in the registry record.
Why does early termination matter statistically?
Early termination can limit the amount of outcome information available, especially for a time-to-event endpoint that depends on events and follow-up. The impact depends on the reason for stopping, the timing, the data collected, and the analysis procedures. The registry attributes termination to business reasons and states that no efficacy data were collected. It does not report whether any efficacy data were gathered before termination and then excluded, or whether any analysis was undertaken outside the registry record. No conclusion about the consequences for statistical power or bias can be made from the information recorded.
The registry reports no analyses for the listed outcomes. It gives no DFS effect estimate, confidence interval, p-value, or analysis model. Any statistical description beyond the study design and the posted safety counts would therefore require information not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity concerns arise when a study tests several outcomes, treatment contrasts, subgroups, or time points. In general, conducting multiple tests without an appropriate strategy can increase the chance of a false-positive result. A prespecified hierarchy or adjustment can help control that risk. The registry lists DFS as the primary outcome and also lists overall survival and treatment-emergent adverse events among secondary outcomes. However, the statistical plan for managing multiplicity is not reported in the registry record.
The record does not report an analysis of DFS, and no efficacy data were collected. It therefore does not show whether any multiplicity procedure was applied or whether secondary outcomes were analyzed. The registry’s outcome listings alone do not establish how the study would have prioritized or interpreted multiple results.
Missing-data methods and analysis populations are also not reported in the registry record. The record does not specify whether the intended efficacy analysis would use all randomized participants, a modified group, or another population, nor does it describe how missing outcome assessments or incomplete follow-up would be handled. For time-to-event outcomes, censoring rules and follow-up information are important parts of interpreting an analysis; beyond the endpoint definition, these details are unavailable.
The fact that the outcome was not reported should not be treated as a missing value that can be statistically imputed from the posted record. There are no efficacy data in the registry record from which to reconstruct the intended comparison. The missing analysis plan and population definitions further limit what can be inferred about how results would have been estimated.
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 |
|---|---|---|---|
| Placebo | 3 | 37 | 8.1% |
| ADXS11-001 | 10 | 72 | 13.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 1 of 37 |
| ADXS11-001 | 5 of 72 |
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 |
|---|---|
| Placebo | 30 of 37 |
| ADXS11-001 | 62 of 72 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | ADXS11-001 |
|---|---|---|---|
| Cytokine release syndrome | Immune system disorders | 0 of 37 | 2 of 72 |
| Colitis | Gastrointestinal disorders | 1 of 37 | 0 of 72 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 0 of 37 | 1 of 72 |
| Intestinal obstruction | Gastrointestinal disorders | 0 of 37 | 1 of 72 |
| Rectal haemorrhage | Gastrointestinal disorders | 0 of 37 | 1 of 72 |
| Chest discomfort | General disorders | 1 of 37 | 0 of 72 |
| Cholecystitis acute | Hepatobiliary disorders | 0 of 37 | 1 of 72 |
| Kidney infection | Infections and infestations | 1 of 37 | 0 of 72 |
| Urinary tract infection | Infections and infestations | 0 of 37 | 1 of 72 |
| Radiation proctitis | Injury, poisoning and procedural complications | 1 of 37 | 0 of 72 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | ADXS11-001 |
|---|---|---|---|
| Pyrexia | General disorders | 1 of 37 | 27 of 72 |
| Headache | Nervous system disorders | 7 of 37 | 20 of 72 |
| Nausea | Gastrointestinal disorders | 4 of 37 | 20 of 72 |
| Chills | General disorders | 0 of 37 | 23 of 72 |
| Hypotension | Vascular disorders | 5 of 37 | 14 of 72 |
| Anaemia | Blood and lymphatic system disorders | 3 of 37 | 14 of 72 |
| Fatigue | General disorders | 4 of 37 | 13 of 72 |
| Abdominal pain | Gastrointestinal disorders | 6 of 37 | 8 of 72 |
| Cytokine release syndrome | Immune system disorders | 1 of 37 | 11 of 72 |
| Vomiting | Gastrointestinal disorders | 1 of 37 | 10 of 72 |
Serious events with the highest arm-level rate: cytokine release syndrome (2.8%), colitis (2.7%), chest discomfort (2.7%), kidney infection (2.7%), radiation proctitis (2.7%).
The registry lists serious adverse event counts by group. For placebo, it reports 37 participants at risk and 3 affected; for ADXS11-001, it reports 72 participants at risk and 10 affected. These are descriptive counts in the registry record. They do not establish that an event was caused by the assigned treatment, and the record does not provide a comparative statistical analysis of these counts.
The record also lists other adverse events: 30 affected among 37 at risk for placebo and 62 affected among 72 at risk for ADXS11-001. The listed deaths are 1 for placebo and 5 for ADXS11-001. The record does not provide additional context for interpreting the deaths as treatment-related or unrelated. These counts should not be read as a causal comparison.
Serious adverse event terms listed with percentages include cytokine release syndrome (2.8%), colitis (2.7%), chest discomfort (2.7%), kidney infection (2.7%), radiation proctitis (2.7%), and gastrooesophageal reflux disease (1.4%). The denominator and group-specific context for these percentages are not reported in the registry record. They should therefore be read as listed terms and percentages, not as directly comparable group-specific rates. The safety information does not fill the gap in the missing DFS results.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized Phase 3 study was intended to compare ADXS11-001 with placebo after chemoradiation in participants with high-risk locally advanced cervical cancer. It defines DFS as time from randomization to recurrence or death and describes how recurrence was to be confirmed. It also documents termination for business reasons and states that no efficacy data were collected.
Those details do not show whether ADXS11-001 changed DFS relative to placebo. The record contains no primary efficacy estimate, no confidence interval, and no efficacy test result. A missing result is not a finding of no difference. It also cannot be used to claim that a difference exists. The direction, size, and precision of the intended treatment comparison are unknown from the posted results.
The safety counts provide limited descriptive information about reported adverse events and deaths in the groups. They do not establish treatment causation, and they do not provide a substitute measure of efficacy. The serious adverse event percentages are listed without the denominator and group-specific context needed for a direct comparison. Any stronger conclusion about relative safety would require details not reported in the registry record.
The trial’s status and stated reason for termination also matter when interpreting the record. The registry says the study ended early for business reasons, rather than reporting a completed efficacy comparison. It does not give the rationale for stopping beyond that description, nor does it report whether planned analyses were conducted elsewhere. The most accurate conclusion is that the intended clinical question is unanswered in the registry record, while the listed design features and adverse-event counts remain descriptive information.
13. Why This Trial Matters Statistically
This study is statistically important because it illustrates the distinction between a trial’s planned question and an available result. A randomized design and a clearly defined primary endpoint can support a comparative analysis when outcome data are collected and reported. Here, the registry documents those intentions but states that the primary endpoint was not reported and no efficacy data were collected.
That distinction is especially important for time-to-event outcomes. Enrollment by itself does not indicate how many recurrences or deaths occurred, how long participants were followed, or how precisely a treatment effect could be estimated. The registry gives an enrollment figure and a maximum duration for the stated endpoint timeframe, but it does not provide the observed event experience or a DFS analysis. Readers therefore cannot infer the amount of information available for the planned comparison.
The record also underscores the value of transparent reporting about trial status and missing outcomes. It identifies business reasons for termination, but it does not report the statistical plan, analysis populations, or a primary efficacy result. That absence limits both clinical interpretation and statistical appraisal: the intended comparison cannot be checked against a reported estimate and its uncertainty.
Finally, safety counts and efficacy outcomes answer different questions. Adverse-event information can describe events recorded during the study, but it cannot establish a DFS effect. Keeping these evidence types separate helps avoid treating the presence of a study, or a set of descriptive safety counts, as an efficacy conclusion.
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 principal limitation is that the registry explicitly states that DFS was not reported because the study was terminated early due to business reasons, and that no efficacy data were collected. The intended primary comparison therefore has no reported outcome estimate. There is no reported confidence interval or efficacy test result, and no basis in this record for assessing the size, direction, or precision of a DFS difference.
The registry does not report the statistical analysis plan, including the intended DFS model, test, handling of censoring, analysis population, or any approach to missing data. It also does not report whether interim analyses were planned or performed. The method of randomization and the identities of the masked parties are not specified. These omissions prevent detailed assessment of the planned or executed efficacy methods.
Safety reporting is also limited in context. The registry gives counts for serious and other adverse events and lists deaths, but does not provide a comparative statistical analysis or additional information establishing causality. For the serious adverse event terms with percentages, the denominator and group-specific context are not reported in the registry record. The counts should therefore be interpreted descriptively.
The registry records enrollment as 110, while the adverse-event listings give group-specific at-risk counts. The record does not explain the relationship between these figures or provide a participant disposition account. The available arm descriptions are truncated, limiting detail on treatment discontinuation instructions. These limitations do not alter the stated absence of efficacy data, but they further restrict interpretation of the study record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer — NCT02853604.
- Registry record last updated 2023-03-14; status last verified 2023-02.
- Results first posted 2023-03-14.
- 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 randomized, quadruple-masked, parallel-group Phase 3 study was designed to compare ADXS11-001 with placebo after cisplatin-based combination chemotherapy and radiation therapy in high-risk locally advanced cervical cancer. The primary endpoint was DFS, defined as time from randomization until recurrence or death, with recurrence determined by pathologic confirmation or, when tissue sampling was not medically feasible, independently reviewed radiographic evidence.
The registry lists enrollment as 110, gives the study status as terminated, and states that termination was due to business reasons. It explicitly says no efficacy data were collected and that DFS was not reported. The record includes descriptive adverse-event counts and selected serious adverse event terms, but no efficacy analysis. The intended treatment comparison therefore remains unanswered in the registry record.