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 PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer (NCT04493619), a non-randomized phase 1, phase 2 study. The primary outcome is Phase 2a (PLX2853 Monotherapy): Number of Participants With Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04493619 |
| Phase | Phase 1, Phase 2 |
| Condition | Gynecologic Neoplasms, Epithelial Ovarian Cancer |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 37 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Opna Bio LLC |
| Results posted | Yes |
2. Clinical Question
Population
The monotherapy group was intended for participants with advanced gynecological malignancies and a known ARID1A mutation. The combination groups were for participants with platinum-resistant epithelial ovarian cancer. These are distinct clinical populations, so outcomes across the groups would not automatically answer the same question.
Intervention
The study evaluated PLX2853 as a single agent at 80 mg and in combination with carboplatin. The combination arm descriptions include PLX2853 at 40 mg and at 80 mg. The registry record describes the study purpose as evaluating safety, pharmacokinetics, pharmacodynamics and preliminary efficacy.
Comparator
No randomized control group is described. The study was nonrandomized, open-label and parallel, and the registry record cautions that its arms are not a like-for-like control comparison. Any differences between arms could reflect their distinct populations and treatment regimens, as well as other factors.
Primary question
The primary outcome listed for the Phase 2a monotherapy group was the number of participants with an overall response, assessed using RECIST v1.1. The record states that this outcome was not evaluated: early discontinuation meant continued collection of disease status did not occur. Thus, the registry record does not report an answer to the primary response question.
3. Trial Design
NCT04493619 was a multicenter, open-label, parallel study with Phase 1 and Phase 2 components. Its official title describes Phase 2a monotherapy with PLX2853 in advanced gynecological malignancies with a known ARID1A mutation, and Phase 1b/2a combination therapy with PLX2853 and carboplatin in platinum-resistant epithelial ovarian cancer. The registry lists the allocation as nonrandomized and masking as none.
The listed treatment groups include Phase 2a PLX2853 monotherapy at 80 mg, and combination therapy groups identified as Phase 1b PLX2853 at 40 mg plus carboplatin, Phase 1b PLX2853 at 80 mg plus carboplatin, and Phase 2a PLX2853 at 80 mg plus carboplatin. The monotherapy group and combination groups had different eligibility descriptions. The registry does not report participant counts by treatment group in the information available for this record.
The listed enrollment was 37. The study started on 2020-08-11, and primary completion was 2022-04-25. Its status is terminated. These dates describe the registry record and do not, on their own, explain the timing or reasons for discontinuation. A reason beyond the primary outcome description is not reported in the registry record.
Because treatment assignment was not randomized and no masking was used, the design is descriptive rather than a controlled comparison of treatments. In general, random assignment is used to make groups more comparable with respect to known and unknown factors. Without it, and especially where the groups have different diseases or treatment regimens, apparent differences cannot be attributed to treatment alone. The registry itself cautions that the arms are not a like-for-like control 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.
Overall Study
| Stage | Phase 2a | Phase 1b Combination | Phase 1b | Phase 2a Combination |
|---|---|---|---|---|
| STARTED | 14 | 3 | 7 | 13 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 14 | 3 | 7 | 13 |
Reasons for not completing this period:
| Reason | Phase 2a | Phase 1b Combination | Phase 1b | Phase 2a Combination |
|---|---|---|---|---|
| Death | 4 | 3 | 3 | 4 |
| Study discontinued early | 10 | 0 | 4 | 8 |
| Lost to Follow-up | 0 | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: This outcome measure was not evaluated. The study was discontinued early and continued collection of disease status, which is required to determine overall response rate (ORR), was not conducted, therefore this measure is not reportable.
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 | PLX2853 Phase 2a Monotherapy | PLX2853 (40 mg) + Carboplatin Phase 1b | PLX2853 (80 mg) + Carboplatin Phase 1b | PLX2853 + Carboplatin Phase 2a Combination Therapy | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 14 | 3 | 7 | 13 | 37 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 10 | 2 | 4 | 9 | 25 |
| Age, Categorical: >=65 years | Participants | 4 | 1 | 3 | 4 | 12 |
| Sex: Female, Male: Female | Participants | 14 | 3 | 7 | 13 | 37 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 0 | 0 | 11 | 14 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 9 | 3 | 5 | 0 | 17 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 0 | 2 | 2 | 6 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 1 | 2 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 2 | 2 | 0 | 4 |
| Race (NIH/OMB): White | Participants | 11 | 1 | 4 | 11 | 27 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 | 0 | 0 | 0 | 3 |
| Region of Enrollment: Canada | participants | 0 | 0 | 0 | 3 | 3 |
| Region of Enrollment: United States | participants | 14 | 0 | 7 | 10 | 34 |
6. Primary Endpoint
The registry lists the primary outcome as Phase 2a (PLX2853 Monotherapy): Number of Participants With Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), measured over From 8 weeks of treatment for only PLX2853 (Cycle 3 Day 1; 28 days per cycle) until completion of long term follow-up, an average of 6 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 outcome listed for the Phase 2a PLX2853 monotherapy group is the number of participants with an overall response rate measured according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). The stated timeframe begins from 8 weeks of treatment, at Cycle 3 Day 1, with 28 days per cycle, and continues until completion of long term follow-up, described as an average of 6 months.
In general, an overall response endpoint uses defined disease-response criteria to describe whether participants meet a threshold for response during assessment. Such an endpoint can provide a structured way to summarize tumor response in a clinical study. The registry’s description does not provide response counts or a response estimate, however. It explicitly says the outcome was not evaluated because the study was discontinued early and continued disease-status collection, required to determine overall response rate, was not conducted.
Therefore, the endpoint is a planned measure, not a reported efficacy result. The registry record does not provide a response rate, an uncertainty interval, or an analysis of response for this primary outcome. The stated timeframe should not be mistaken for evidence that participants completed follow-up or that disease status was collected throughout that period.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the primary response outcome was not evaluated. The registry states that the study was discontinued early and that continued collection of disease status, required to determine overall response rate, was not conducted. As a result, there is no registry-reported primary response estimate to interpret. The record does not establish how often participants responded to PLX2853 monotherapy, nor does it report a precision estimate for that endpoint.
The registry lists enrollment of 37 and gives separate safety summaries for PLX2853 Phase 2a monotherapy and PLX2853 plus carboplatin Phase 1b/2a combination therapy. Those safety summaries are not substitutes for the missing primary outcome. The arms are nonrandomized and differ in their stated populations and regimens. The registry cautions that they are not a like-for-like control comparison. Comparisons between their counts would therefore not isolate a treatment effect.
The record lists 14 participants at risk for serious adverse events in the monotherapy group, with 6 affected, and 23 at risk in the combination group, with 10 affected. It also lists other adverse events and deaths by group. These are descriptive counts. They do not, by themselves, indicate whether events were caused by treatment, whether differences between groups are meaningful, or how complete event ascertainment was. The registry record does not report a causal assessment alongside these counts.
In general, a missing endpoint is not the same as an endpoint showing no response. Here, the stated reason for non-evaluation is that the necessary continued disease-status collection was not conducted. It would be inappropriate to interpret the absent response result as evidence either for or against activity. Similarly, absence of a reported comparison does not establish that treatments were equivalent or different.
The record reports no analyses in the analysis summary, and it does not report inferential results for the primary endpoint. It also does not report a statistical analysis plan, a sample-size justification, or interim analyses. The posted sample-size illustrations, where applicable, should be understood as planning calculations rather than observed power or evidence about the study’s results. Overall, the available registry information supports a description of design, status and reported safety counts, but not a conclusion about primary efficacy.
9. Statistical Methods Explained
Statistical interpretation depends on the distinction between a study plan and an analyzed outcome. The registry names overall response rate as the primary outcome for Phase 2a monotherapy, but also states that it was not evaluated. Naming an endpoint does not create an estimate: an endpoint requires collected outcome data and an analysis. In this record, the stated lack of continued disease-status collection prevented determination of response.
What an outcome estimate would describe
In general, an endpoint estimate summarizes the observed outcome in the participants analyzed for that endpoint. For a response endpoint, that means identifying participants who meet the stated response criteria and relating that count to the population defined for analysis. The registry does not report the response count, the denominator used for this endpoint, or an estimate. It therefore does not permit interpretation of response frequency or precision. The timeframe is described as beginning from 8 weeks of treatment and extending through long term follow-up, an average of 6 months; it is not evidence that all planned assessments occurred.
Why design matters for comparisons
In general, randomization helps balance prognostic characteristics across treatment groups, while masking can reduce the influence of expectations on assessment. This trial is listed as nonrandomized and unmasked. Its monotherapy population has advanced gynecological malignancies with a known ARID1A mutation; the combination population has platinum-resistant epithelial ovarian cancer. The interventions also differ. Those design features make an across-group contrast unsuitable as a simple treatment comparison. Even a numerical difference in outcome counts could reflect population composition, treatment context, follow-up or other factors.
The parallel structure means the treatment groups are described as separate groups rather than as repeated treatment periods within the same participants. The registry lists Phase 1 and Phase 2 components and several treatment-group descriptions, but it does not report a randomized comparison. The registry’s warning that the arms are not like-for-like is important: group counts should be read descriptively and not as an estimate of relative benefit or harm.
What uncertainty can and cannot be assessed
In general, a confidence interval expresses the range of estimates reasonably compatible with the observed data under the statistical model used. It helps readers judge precision, rather than simply whether a result crosses a threshold. No confidence interval or primary response estimate is reported for this study. Thus, precision for the principal efficacy question cannot be assessed from the registry record.
In general, statistical significance tests evaluate data against a specified null hypothesis under assumptions. Their interpretation depends on a prespecified analysis, the endpoint, the analysis population and the handling of missing observations. The record reports zero analyses in its analysis summary and does not report a primary endpoint test. It does not state the planned significance threshold or whether any testing strategy was specified. A nonsignificant finding should not be inferred; no primary response test is reported.
The record includes sample-size assumptions for planning illustrations: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. These are assumptions for illustrations, not a description of the trial’s own design justification. In general, a planning sample size describes the number of participants needed under chosen assumptions. It is not a measure of observed power after results, and it cannot recover the unreported response data. The registry does not report the trial’s sample-size justification.
Safety counts and event distributions
The safety summaries report participant counts for serious and other adverse events and deaths within the listed groups. In general, counts provide an account of events recorded in the study, but interpretation also depends on definitions, exposure, follow-up, attribution and completeness of reporting. The registry lists serious adverse event terms with percentages, but the denominator and the basis for those percentages are not reported in the registry record. The percentages should therefore be read as registry-listed values, not recalculated or treated as directly comparable group risks.
Over-dispersion is a general issue when variability in count outcomes exceeds what a simple count model assumes. It can make model-based uncertainty too narrow if the model does not account for extra variability. No count-model analysis or modeling assumptions are reported for this study, so this concept cannot be used to infer a trial result. More broadly, statistical methods can clarify uncertainty only when the relevant data and analysis specifications are available; they cannot replace the primary response information that was not collected.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a multiplicity strategy. Multiplicity is a general concern when a study tests several outcomes, doses, groups or time points: repeated testing can increase the chance of at least one apparently positive result by chance. Statistical plans may address this through a prespecified hierarchy or adjustment, but whether either approach was planned for this study is not reported in the registry record. No conclusion about multiplicity control should be inferred from the listed outcomes alone.
The analysis summary reports zero analyses. The record does not report an analysis plan, a prespecified analysis population, or details about which participants would have been included in an efficacy analysis. It consequently is not possible to determine whether the planned analysis was based on all enrolled participants, participants who received treatment, or another defined group. Those distinctions matter in general because different analysis populations can answer different questions.
For the primary response outcome, the registry gives a specific reason the measure was not reportable: early discontinuation meant continued collection of disease status required to determine overall response rate was not conducted. This is an endpoint-specific data limitation, not a response value of zero. The record does not describe other missing-data patterns, the number of participants with incomplete assessments, or any planned method for handling missing observations. Those details are not reported in the registry record.
In general, missing outcome data can affect both the estimate and its precision, and the effect depends on why data are missing and how missingness relates to outcomes. Without the missingness pattern and analysis approach, the direction or size of any potential bias cannot be established. Here, the registry’s explicit explanation supports the conclusion that the primary response endpoint cannot be interpreted, not an assumption about what the unobserved responses would have been.
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 |
|---|---|---|---|
| PLX2853 Phase 2a Monotherapy | 6 | 14 | 42.9% |
| PLX2853 + Carboplatin Phase 1b/2a Combination Therapy | 10 | 23 | 43.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| PLX2853 Phase 2a Monotherapy | 5 of 14 |
| PLX2853 + Carboplatin Phase 1b/2a Combination Therapy | 11 of 23 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| PLX2853 Phase 2a Monotherapy | 14 of 14 |
| PLX2853 + Carboplatin Phase 1b/2a Combination Therapy | 20 of 23 |
Most frequent serious adverse event terms
| Event term | Organ system | PLX2853 Phase 2a Monotherapy | PLX2853 + Carboplatin Phase 1b/2a Combination Therapy |
|---|---|---|---|
| anemia | Blood and lymphatic system disorders | 2 of 14 | 1 of 23 |
| obstruction gastric | Gastrointestinal disorders | 2 of 14 | 1 of 23 |
| small intestinal obstruction | Gastrointestinal disorders | 1 of 14 | 1 of 23 |
| dehydration | Metabolism and nutrition disorders | 0 of 14 | 2 of 23 |
| sepsis | Infections and infestations | 1 of 14 | 0 of 23 |
| abdominal pain | Gastrointestinal disorders | 1 of 14 | 0 of 23 |
| thrombocytopenia | Blood and lymphatic system disorders | 1 of 14 | 0 of 23 |
| hepatic hematoma | Hepatobiliary disorders | 1 of 14 | 0 of 23 |
| fatigue | General disorders | 1 of 14 | 0 of 23 |
| large intenstinal obstruction | Gastrointestinal disorders | 1 of 14 | 0 of 23 |
Most frequent non-serious adverse event terms
| Event term | Organ system | PLX2853 Phase 2a Monotherapy | PLX2853 + Carboplatin Phase 1b/2a Combination Therapy |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 11 of 14 | 18 of 23 |
| Fatigue | General disorders | 7 of 14 | 13 of 23 |
| Platelet count decreased | Investigations | 4 of 14 | 16 of 23 |
| Vomiting | Gastrointestinal disorders | 6 of 14 | 10 of 23 |
| Abdominal pain | Gastrointestinal disorders | 5 of 14 | 8 of 23 |
| Anemia | Blood and lymphatic system disorders | 6 of 14 | 6 of 23 |
| Diarrhea | Gastrointestinal disorders | 4 of 14 | 7 of 23 |
| Decreased appetite | Metabolism and nutrition disorders | 2 of 14 | 7 of 23 |
| Constipation | Gastrointestinal disorders | 1 of 14 | 7 of 23 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 2 of 14 | 6 of 23 |
Serious events with the highest arm-level rate: anemia (14.3%), obstruction gastric (14.3%), dehydration (8.7%), sepsis (7.1%), abdominal pain (7.1%).
The registry reports serious adverse event counts separately for the PLX2853 Phase 2a monotherapy group and the PLX2853 plus carboplatin Phase 1b/2a combination group. The monotherapy group has 14 participants at risk and 6 affected; the combination group has 23 at risk and 10 affected. Other adverse event counts are 14 at risk and 14 affected for monotherapy, and 23 at risk and 20 affected for combination therapy. The record also lists 5 deaths in the monotherapy group and 11 in the combination group.
These are descriptive group-level figures, not a randomized comparison. The groups differ in stated population and regimen, so their counts should not be read as demonstrating a difference caused by treatment. The registry does not report whether the listed deaths were attributed to treatment. The percentages attached to the listed serious-event terms include anemia, obstruction gastric, dehydration, sepsis, abdominal pain and thrombocytopenia; the denominator and basis for these percentages are not reported in the registry record.
In general, adverse event counts describe events recorded under a study’s reporting process. Their interpretation depends on event definitions, follow-up, exposure and attribution. The counts alone do not establish causation or comparative risk.
12. What the Result Does, and Does Not, Mean
The record establishes that this study evaluated PLX2853 as monotherapy and with carboplatin in distinct clinical populations, and that it was terminated. It also establishes that the primary response outcome for Phase 2a monotherapy was not evaluated because continued disease-status collection was not conducted after early discontinuation. Consequently, the record does not provide a primary response estimate or its precision.
This does not mean that the response rate was zero, that no participant responded, or that the treatment had no activity. It also does not support the opposite claim. The necessary response data are not reported. A missing endpoint is an absence of an estimate, not a negative estimate. The registry’s explanation identifies why this particular endpoint could not be determined, but does not describe what the unobserved outcomes would have been.
The safety entries document reported counts for serious and other adverse events and deaths in the listed groups. These figures can describe what the registry records, but do not establish that an event was caused by PLX2853 or carboplatin. Nor do they allow a direct comparison of treatment regimens: allocation was nonrandomized, masking was absent, and the groups had different eligibility descriptions. The record itself cautions against treating the arms as like-for-like controls.
In general, a clinical trial’s interpretation depends on its design, endpoint data, analysis population, statistical plan and follow-up. Several of those details are not reported in the registry record. There are no reported primary analyses from which to assess a treatment contrast or quantify uncertainty. Any planning illustration is not observed power and does not supply missing clinical outcome data.
The defensible conclusion is limited: the registry describes the study’s aims and design, gives certain safety counts, and states that the primary overall response outcome was not reportable. Efficacy, comparative safety and causal claims cannot be established from these registry results.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it distinguishes an endpoint specified in a study record from an endpoint that was actually evaluated. Overall response rate was named as the primary outcome for Phase 2a monotherapy, but the record states that the disease-status collection needed to determine it did not continue after early discontinuation. The absence of an estimate is therefore central to interpretation, not a minor reporting detail.
The design also shows why a treatment-group label is not enough to justify a comparison. The study was nonrandomized and open-label. Monotherapy was studied in advanced gynecological malignancies with a known ARID1A mutation, while combination therapy was studied in platinum-resistant epithelial ovarian cancer. Different populations and regimens make an across-group contrast difficult to interpret as a treatment effect. The registry explicitly cautions that the groups are not like-for-like controls.
The safety summaries remain useful as descriptions of the counts recorded for each group, but they do not remove these design limitations. Without treatment attribution, comparable groups and an inferential analysis, the counts cannot establish causal or comparative conclusions. Similarly, planning calculations based on assumptions are not a substitute for an observed endpoint estimate, and cannot be interpreted as observed power.
In general, sound statistical interpretation requires keeping distinct the intended question, the data collected, and the analysis actually reported. This record makes that distinction visible: it documents a primary question but does not provide the outcome needed to answer it. That is an important limit on what readers can conclude, even when other descriptive information is available.
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 specific to this trial is that its listed primary endpoint was not evaluated. The registry states that early discontinuation stopped continued disease-status collection required to determine overall response rate. It does not report the response count, estimate, or precision. The stated endpoint timeframe, from 8 weeks of treatment through long term follow-up with an average of 6 months, does not establish that the planned assessments were completed.
The study was nonrandomized, open-label and parallel. The monotherapy and combination populations were distinct, and the treatment regimens differed. The registry cautions that the arms are not a like-for-like control comparison. Therefore, differences in descriptive counts cannot be interpreted as isolated treatment effects. The record does not report separate participant counts by treatment group in the information.
The registry reports safety counts, but it does not report event attribution, a denominator or basis for the percentages attached to serious-event terms, or a comparative statistical analysis. Counts of deaths are listed, but their relationship to treatment is not reported. Other details relevant to interpreting safety, including the full follow-up and event-collection context, are not reported in the registry record.
The record also does not report the trial’s statistical analysis plan, sample-size justification, interim analyses, analysis populations, multiplicity approach, or methods for handling missing outcomes. The number of analyses listed is zero. These omissions limit evaluation of the intended inferential strategy and the precision of any potential findings. The listed planning assumptions do not establish the trial’s actual design justification, nor do they provide evidence of observed power.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer — NCT04493619.
- Registry record last updated 2024-11-04; status last verified 2024-10.
- Results first posted 2024-11-04.
- 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
NCT04493619 is a terminated, multicenter, open-label, nonrandomized parallel study with Phase 1 and Phase 2 components. It evaluated PLX2853 monotherapy in advanced gynecological malignancies with a known ARID1A mutation and PLX2853 with carboplatin in platinum-resistant epithelial ovarian cancer. Listed enrollment was 37; the study started on 2020-08-11, with primary completion on 2022-04-25.
The primary outcome listed for Phase 2a monotherapy was overall response measured by RECIST v1.1. The registry states that it was not evaluated because continued disease-status collection was not conducted after early discontinuation. Safety counts are reported for the monotherapy and combination groups, but the record cautions that the nonrandomized arms are not like-for-like controls. No primary efficacy analysis is reported.