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 A Trial of FANG™ Vaccine for Participants With Ovarian Cancer (NCT01309230), a randomized phase 2 study. The primary outcome is Time to Recurrence (TTR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01309230 |
| Phase | Phase 2 |
| Condition | Ovarian Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 39 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Gradalis, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Women with ovarian cancer who underwent planned surgery, completed standard chemotherapy, and had no evidence of remaining cancer were considered for randomization if the study requirements were met and Vigil could be made from their cancer cells. The primary analysis included participants who achieved complete clinical response at study entry. The registry describes the intended population as people with high-risk stage III/IV ovarian cancer.
Intervention
Vigil, an investigational immunotherapy made using the participant’s removed tumor cells, was given as maintenance treatment after chemotherapy. Group A received intradermal injections monthly, starting at least three weeks after chemotherapy and no later than 2.5 months afterward. The planned course ranged from a minimum of 4 doses to a maximum of 12 doses.
Comparator
Group B received standard of care without maintenance therapy. The study summary describes this comparison as Vigil versus no further treatment after completion of standard chemotherapy, for participants who met the response and eligibility conditions.
Primary question
The main question was whether time to recurrence differed between the randomized groups. Recurrence was assessed using radiological tumor assessment and specified CA-125 criteria. The endpoint also counted death before documented recurrence as an event. The posted results give a median for each arm, but no estimable two-arm comparison is reported in the registry record.
3. Trial Design
This was a randomized, open-label, parallel-group Phase II trial sponsored by Gradalis, Inc. The registry lists enrollment of 39 participants and the trial status as completed. The registry title refers to a FANG vaccine, while the intervention and arm descriptions identify the product as Vigil. The record does not explain this difference in naming.
The treatment sequence began with planned surgery to remove cancerous tissue. Cells from the removed tumor were used in an attempt to manufacture the investigational product. Eligible participants then received standard chemotherapy. After chemotherapy, participants with no evidence of remaining cancer and complete clinical response could be randomly assigned to Vigil or the observational standard-of-care group, which did not receive maintenance therapy.
Vigil was administered monthly by intradermal injection. The registry describes a minimum of 4 doses and a maximum of 12 doses, beginning at least three weeks after chemotherapy and no later than 2.5 months afterward. The control arm received standard of care without maintenance therapy. Masking was listed as none, so the study was open-label; the registry does not describe blinded outcome assessment.
The primary outcome was time to recurrence, measured from treatment start to the first recurrence or to death if death occurred before recurrence. Its stated assessment period was approximately 3 years, with radiographic assessments at baseline, within one week before Cycle 4, at standard-of-care intervals, and when CA-125 was >35 U/mL. The registry does not report the method used to generate the random sequence or conceal treatment allocation.
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: Thirty-nine (39) subjects had product manufactured and consented to randomize on CL-PTL-105.
Overall Study
| Stage | Group A: Vigil™ Alone | Group B: Standard of Care |
|---|---|---|
| STARTED | 28 | 11 |
| COMPLETED | 28 | 7 |
| NOT COMPLETED | 0 | 4 |
Reasons for not completing this period:
| Reason | Group A: Vigil™ Alone | Group B: Standard of Care |
|---|---|---|
| Withdrawal by Subject | 0 | 2 |
| Observation arm closed | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: Participants who achieved complete clinical response (cCR) at the time of study entry were included in the analysis. After randomization, two participants from Group A were deemed unevaluable as they did not achieve cCR.
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 | Group A (Vigil™) | Group B (Observational - Standard of Care) | Total |
|---|---|---|---|---|
| Participants analysed | 28 | 11 | 39 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 18 | 7 | 25 |
| Age, Categorical: >=65 years | Participants | 10 | 4 | 14 |
| Sex: Female, Male: Female | Participants | 28 | 11 | 39 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 27 | 11 | 38 |
| 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 | 1 | 0 | 1 |
| 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 | 27 | 11 | 38 |
| 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 | 28 | 11 | 39 |
| CA-125 Level: CA-125 > 10 U/ML but ≤ 20 U/mL | Participants | 10 | 8 | 18 |
| CA-125 Level: CA-125 ≤ to 10 U/mL | Participants | 17 | 3 | 20 |
| CA-125 Level: CA-125 > 20 U/mL | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Recurrence (TTR), measured over Treatment start to the date of first recurrence or date of death if the participant died before recurrence. Radiographic assessment at baseline, </= 1 week prior to Cycle 4, at Standard of Care intervals, and when CA-125>35 U/mL, approximately 3 years..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Time to recurrence (TTR) measures the time from treatment start until the first documented recurrence. The registry also counts death before recurrence as an event. Recurrence was defined through radiological tumor assessment by local investigators using RECIST, Version 1.1, or through asymptomatic CA-125 levels >35 U/mL at two consecutive measurements at least one month apart.
A time-to-event endpoint retains information about when an event occurs, rather than reducing follow-up to a simple count of participants with recurrence. Its median describes the central point of the observed time-to-event distribution, while a confidence interval conveys uncertainty around that estimate. The 95% confidence interval is not a range containing most individual participants’ recurrence times.
The posted median TTR was 18.2 months for Group A, with a 95% confidence interval from 14.7 to 43.4 months. For Group B, the median was 12.4 months, with a lower confidence limit of 10.2 months; an upper confidence limit was not reported. These arm-specific estimates alone do not establish the size or statistical certainty of a treatment contrast. The registry record does not report an estimable two-arm comparison for this median-time endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary results report a median time to recurrence of 18.2 months in Group A (Vigil), with a 95% confidence interval of 14.7 to 43.4 months. Group B (observational standard of care) had a median of 12.4 months, with a reported lower confidence limit of 10.2 months and no reported upper confidence limit. These are estimates for the individual arms; they are not themselves an estimate of the difference between arms.
The registry marks the two-arm comparison as unavailable or not estimable for this median time-to-event endpoint. No hazard ratio, confidence interval for a relative effect, or p-value for the primary comparison is posted. The registry record does not report an analysis that supports a formal claim about the comparative effect of assignment to Vigil. A comparison based only on the arm medians would omit uncertainty in the contrast and the timing of events, so it should not be substituted for a sponsor-reported comparative analysis.
The confidence intervals communicate uncertainty in the arm-specific median estimates. Group A’s interval extends from 14.7 to 43.4 months. Group B’s upper limit is not reported, which leaves its interval incompletely described in the registry. Confidence intervals do not identify the range of outcomes for individual participants, and their endpoints should not be interpreted as observed minimum and maximum recurrence times.
The primary analysis population was participants who achieved complete clinical response at study entry. After randomization, two participants from Group A were deemed unevaluable because they did not achieve complete clinical response. The posted primary arm counts are 26 for Group A and 11 for Group B. Enrollment was 39; these figures refer to different stages or analysis populations and should not be treated as interchangeable. The registry does not provide enough detail to reconstruct every participant’s path from enrollment through randomization and endpoint analysis.
Because the record does not give an estimable contrast, neither the arm medians nor their separate confidence intervals establish whether the groups differ beyond chance. The results describe the posted estimates and their precision, not a definitive comparative conclusion. Sponsor-reported comparative results take precedence when available; a comparative estimate is not reported in the registry record.
9. Statistical Methods Explained
Time-to-event methods are designed for outcomes where both whether an event occurs and when it occurs matter. In this trial, recurrence or death before recurrence was the event, and time began at treatment start. Participants whose event was not observed during their available follow-up may contribute information up to the end of that follow-up rather than being treated as if they had experienced recurrence. The registry record does not describe how censoring was handled in the analysis.
What does a median time-to-event estimate mean?
A median is a summary of the event-time distribution for an arm. It gives a central estimate of when events have accumulated in that group, subject to the follow-up and analysis methods. It does not say that every participant experienced recurrence at that time, and it does not describe the full distribution of event times. In this record, the median estimates are 18.2 months for Group A and 12.4 months for Group B.
A median can be estimated from a time-to-event curve even when not all participants have experienced the event, provided the data and follow-up support the estimate. If the curve does not provide enough information to estimate a median or one of its confidence limits, that quantity may be unavailable. Group B’s upper confidence limit is not reported. The registry record does not state why it is absent.
How should the confidence intervals be read?
A confidence interval represents uncertainty around an estimated quantity under the statistical method used. The 95% confidence interval for Group A’s median is 14.7 to 43.4 months. For Group B, the reported lower confidence limit is 10.2 months, while the upper limit is not reported. The interval is not a prediction interval for individual participants and does not mean that the true median is known to lie within the printed bounds with certainty.
Separate arm-specific confidence intervals do not provide the confidence interval for a difference or relative effect. A formal two-arm comparison requires a comparison method that uses the relevant event and follow-up information. The registry indicates that values are missing or not estimable for a two-arm comparison for this median-time endpoint. No comparative hazard ratio or test result is reported in the registry record.
Why does event timing matter?
Two groups can have similar overall event counts but different patterns in when events occur, or have different counts despite similar timing among those who experience events. Time-to-event analysis uses the timing information, while also accounting for participants whose event status is not observed throughout the full follow-up. For that reason, an arm median is only one summary; a relative comparison may use another measure, such as a hazard ratio. No hazard-ratio value for this primary comparison is reported in the registry record.
In general, a hazard ratio summarizes the relative event rate over follow-up under the assumptions of the chosen model. It is not a ratio of median times. Its interpretation depends on the analysis model and whether its assumptions are reasonable. The registry record does not report the model, its assumptions, or a sponsor-reported hazard ratio for this comparison. A new hazard ratio cannot be inferred from the posted medians.
What do the recurrence criteria contribute?
The endpoint used radiological tumor assessment by local investigators under RECIST, Version 1.1, and also allowed recurrence to be identified through specified CA-125 findings. The CA-125 criterion was asymptomatic levels >35 U/mL at two consecutive measurements at least one month apart. Using explicit criteria can make event definitions more consistent, although local assessment and the combination of radiological and laboratory criteria can affect how events are recorded. The registry does not describe independent central review or further procedures for resolving disagreements.
The assessment schedule included baseline imaging, an assessment within one week before Cycle 4, assessments at standard-of-care intervals, and assessment when CA-125 was >35 U/mL. The timeframe was approximately 3 years. The registry does not give further detail about visit completion, the amount of follow-up available for each participant, or the handling of missed assessments.
The registry also includes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations are planning calculations rather than evidence about trial performance or observed power. The posted record does not report the trial’s own sample-size justification or an interim-analysis plan. Those design details should not be inferred from the planning assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three secondary outcomes: the number of participants positive for T-cell and immune activation markers, the predictive potential of tumor-infiltrating lymphocyte and tumor-associated macrophage phenotypes, and Vigil-related adverse events. It lists four outcome measures overall. The record does not report a multiplicity adjustment, a hierarchy among outcomes, or a plan for controlling the chance of false-positive findings across multiple tests. It also does not provide posted comparative analyses for the secondary outcomes.
Multiplicity matters when several outcomes or analyses are tested, because interpreting each result independently can make chance findings more likely across the collection of tests. Without the analysis plan and adjustment details, the extent to which secondary findings were confirmatory or exploratory is not reported in the registry record. No such classification should be inferred from the outcome names alone.
The primary analysis population consisted of participants who achieved complete clinical response at study entry. Two participants from Group A were later deemed unevaluable because they did not achieve complete clinical response. The registry does not provide a full accounting of missing endpoint information, withdrawals, censoring, or reasons for unavailable assessments. It also does not report an intention-to-treat analysis or a detailed method for handling missing data.
These gaps affect interpretation because the analysis population and the treatment of incomplete follow-up can influence time-to-event estimates. Randomization helps balance groups at assignment, but conclusions depend on how randomized participants are included and how incomplete outcome information is treated. The record does not contain enough information to assess these choices fully. The sponsor’s statistical analysis plan, including the prespecified analysis population and missing-data procedures, is not 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 |
|---|---|---|---|
| Group A (Vigil™) | 3 | 28 | 10.7% |
| Group B (Observational - Standard of Care) | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Group A (Vigil™) | 20 of 28 |
| Group B (Observational - Standard of Care) | 7 of 11 |
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 |
|---|---|
| Group A (Vigil™) | 28 of 28 |
| Group B (Observational - Standard of Care) | 9 of 11 |
Most frequent serious adverse event terms
| Event term | Organ system | Group A (Vigil™) | Group B (Observational - Standard of Care) |
|---|---|---|---|
| Urinary tract infection | Infections and infestations | 2 of 28 | 0 of 11 |
| Opiate withdrawal symptoms | General disorders | 1 of 28 | 0 of 11 |
| Bronchitis viral | Infections and infestations | 1 of 28 | 0 of 11 |
| Upper respiratory infection | Infections and infestations | 1 of 28 | 0 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group A (Vigil™) | Group B (Observational - Standard of Care) |
|---|---|---|---|
| Injection site reaction | General disorders | 20 of 28 | 0 of 11 |
| Abdominal pain | Gastrointestinal disorders | 7 of 28 | 4 of 11 |
| Fatigue | General disorders | 8 of 28 | 1 of 11 |
| Constipation | Gastrointestinal disorders | 4 of 28 | 1 of 11 |
| Diarrhea | Gastrointestinal disorders | 5 of 28 | 0 of 11 |
| Back pain | Musculoskeletal and connective tissue disorders | 4 of 28 | 1 of 11 |
| Urinary tract infection | Infections and infestations | 4 of 28 | 0 of 11 |
| Anxiety | Psychiatric disorders | 1 of 28 | 3 of 11 |
| Abdominal bloating | Gastrointestinal disorders | 3 of 28 | 0 of 11 |
| Abdominal discomfort | Gastrointestinal disorders | 3 of 28 | 0 of 11 |
Serious events with the highest arm-level rate: urinary tract infection (7.1%), opiate withdrawal symptoms (3.6%), bronchitis viral (3.6%), upper respiratory infection (3.6%).
For serious adverse events, the registry reports 3 affected participants among 28 at risk in Group A and 0 among 11 at risk in Group B. These are counts of participants affected, not necessarily counts of individual serious events. The record also reports other adverse events affecting 28 of 28 participants in Group A and 9 of 11 in Group B. The safety denominators differ from the primary analysis counts and should be read as the stated safety populations.
Deaths are listed for 20 participants in Group A and 7 in Group B. These counts do not, by themselves, show that deaths were caused by treatment or occurred as a result of an adverse event. The registry record does not report a causal attribution for these deaths in the information.
The listed serious adverse event terms include urinary tract infection at 7.1%, opiate withdrawal symptoms at 3.6%, bronchitis viral at 3.6%, and upper respiratory infection at 3.6%. The record does not specify the denominator for each listed percentage in the information available. These terms and percentages should not be interpreted as a complete description of safety, nor as a comparative risk estimate between groups. Differences in group size and exposure also matter when interpreting raw counts.
12. What the Result Does, and Does Not, Mean
The posted primary outcome describes the median time to recurrence in each randomized arm. The estimate for Group A was 18.2 months, with a 95% confidence interval from 14.7 to 43.4 months. For Group B, the estimate was 12.4 months, with a reported lower confidence limit of 10.2 months and no reported upper limit. Those arm-level results are descriptive estimates with uncertainty.
They do not establish a statistically reliable difference between the groups. The registry does not report an estimable two-arm comparison for the primary median-time endpoint, and no primary comparative hazard ratio, confidence interval, or p-value is reported. A contrast cannot be recovered by comparing the two medians alone. The registry record therefore does not support a claim about the size or statistical certainty of a relative treatment effect based on the posted primary results.
The findings also apply to the analysis population and endpoint definition described in the record. The primary analysis included participants achieving complete clinical response at study entry, and two Group A participants were deemed unevaluable after randomization because they did not achieve complete clinical response. Recurrence was defined using local radiological assessment under RECIST, Version 1.1, or specified CA-125 criteria. Different analysis populations, assessment practices, or definitions could produce different estimates.
The registry results do not establish whether Vigil should be used in clinical care, and they should not be treated as medical advice. They describe what was posted for this trial. The study was randomized and open-label, but details of allocation procedures, analysis methods, missing-data handling, and multiplicity control are not reported in the registry record. These omissions limit independent evaluation of the estimates and their robustness.
Safety counts should also be interpreted as reported, without assuming that an adverse event or death was caused by the intervention. The record presents participants affected and deaths by group, but the listed counts alone do not quantify comparative risk or establish causality. Overall, the record offers arm-specific endpoint estimates and selected safety counts, while leaving the central comparative question unresolved in the posted primary analysis.
13. Why This Trial Matters Statistically
This trial illustrates a common distinction in clinical-trial reporting: an estimate for each arm is not the same as an estimate of the treatment contrast. The median TTR is reported for both groups, but the record does not report an estimable two-arm comparison. Statistical interpretation therefore needs to separate the descriptive results from evidence about a comparative effect.
Time-to-event outcomes also highlight why follow-up and censoring information matter. The endpoint depends on both whether recurrence or death occurs and when it occurs. The registry states an approximate assessment period of 3 years and describes assessment procedures, but does not report the completeness of follow-up or its censoring method. Without those details, readers cannot fully assess how much event-time information underlies the estimates.
The trial also makes the analysis population consequential. Participants were randomized after chemotherapy under eligibility and response conditions, and the primary analysis was limited to participants achieving complete clinical response at study entry. Two Group A participants were deemed unevaluable after randomization. Clear reporting of who was randomized, who was analyzed, and why participants were excluded helps readers assess whether the reported estimates represent the randomized comparison.
Finally, the registry distinguishes the trial’s posted endpoint results from the information needed to reproduce or fully appraise the statistical analysis. The record does not report the comparative model, multiplicity approach, missing-data procedures, or trial-specific sample-size justification. These omissions do not invalidate the arm estimates, but they constrain the conclusions that can be drawn from them. The key statistical lesson is to match the strength of interpretation to the level of analysis actually reported.
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 interpretation is that the registry does not report an estimable two-arm comparison for the primary endpoint. Arm-specific medians are available, but there is no reported comparative hazard ratio, confidence interval for a treatment contrast, or p-value. This leaves the primary comparative question unanswered in the posted results.
Uncertainty is incompletely reported for Group B: its lower confidence limit is 10.2 months, but its upper confidence limit is not reported. The record does not explain why that limit is absent. The precision of the Group B median therefore cannot be reviewed from a complete interval.
The endpoint analysis population and safety populations are not identical as reported. The primary analysis included participants who achieved complete clinical response at study entry, and two Group A participants were deemed unevaluable after randomization. Safety counts use 28 participants at risk in Group A and 11 in Group B. The registry does not provide a complete participant flow to reconcile enrollment, randomization, endpoint analysis, and safety reporting.
Important analysis details are also not reported in the registry record: the statistical model for the primary comparison, handling of censoring and missing assessments, the analysis plan for multiplicity, and whether outcome assessment was independently reviewed. The record does not state the trial-specific sample-size justification or interim-analysis plan. As an open-label study with local investigator radiological assessments, the design may be susceptible to differences in assessment or follow-up practices; the registry does not give information to evaluate the extent of any such effect.
The safety summary provides participant counts and selected serious adverse event terms, but does not give event-level detail or causal attribution for deaths in the information summarized. Consequently, those counts should not be treated as a complete comparative safety analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Trial of FANG™ Vaccine for Participants With Ovarian Cancer — NCT01309230.
- Registry record last updated 2025-06-08; status last verified 2025-06.
- Results first posted 2023-03-24.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry describes a completed, randomized, open-label Phase II trial of Vigil after standard chemotherapy for ovarian cancer. The comparator was standard of care without maintenance therapy. The registry title uses FANG, while the intervention and arm descriptions use Vigil.
The primary outcome was time to recurrence, including death before recurrence. The posted medians were 18.2 months for Group A, with a 95% confidence interval of 14.7 to 43.4 months, and 12.4 months for Group B, with a lower confidence limit of 10.2 months and no reported upper limit. The record does not report an estimable two-arm comparison.
The record lists serious adverse events affecting 3 of 28 participants in Group A and 0 of 11 in Group B, and deaths of 20 and 7 participants, respectively. The posted information does not establish causality or provide a complete comparative analysis. Important statistical details, including missing-data procedures, multiplicity handling, and the trial’s sample-size justification, are not reported in the registry record.