Trial · NCT02915523
Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer
NCT02915523, Phase 1, Phase 2, Completed, Syndax Pharmaceuticals; results first posted 2024-01-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer. Trials, record NCT02915523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02915523
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer
- NCT number
- NCT02915523
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 140 participants, actual
- Lead sponsor
- Syndax Pharmaceuticals
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Interventions
- entinostat, avelumab, Placebo
- First posted
- 2016-09-27
- Last updated
- 2024-01-10
- Results first posted
- 2024-01-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 2: Progression Free Survival (PFS), as Determined by the Local Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days]) | PFS was defined as the number of months from randomization to progressive disease (PD) or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm); the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. |
| Primary | Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE) | Day 1 through Day 28 (Cycles 1 and 2) | A DLT was defined as the occurrence of any protocol-specified event within the first 2 cycles of treatment (from Cycle 1 Day 1 through the end of Cycle 2) of entinostat in combination with avelumab that were considered by the investigator to be at least possibly related to study drug. |
| Secondary | Phase 1b: Recommended Phase 2 Dose (RP2D) | Day 1 through Day 28 (Cycles 1 and 2) | The RP2D was determined in discussion with the Sponsor, Medical Monitor, and Dose Determination Phase Investigators. Additionally, observations related to immune correlates, and any cumulative toxicity observed after multiple cycles might be included in the rationale supporting the RP2D. The RP2D could be equal to or less than the preliminary maximum tolerated dose (MTD). The MTD was defined as the highest dose level at which \<33% of 6 participants experienced DLT. |
| Secondary | Phase 2: PFS, as Determined by the Local Investigator Using Immune Response RECIST (irRECIST) | From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days]) | PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. |
| Secondary | Phase 2: Objective Response Rate (ORR), as Assessed Using RECIST 1.1 | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) | The ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR). CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 2: ORR, as Assessed Using irRECIST | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) | The ORR was defined as the percentage of participants with confirmed CR or PR. CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. |
| Secondary | Phase 2: Clinical Benefit Rate (CBR), as Assessed Using RECIST 1.1 | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) | The CBR was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) lasting for at least 6 months. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Phase 2: CBR, as Assessed Using irRECIST | From date of randomization to date of progression (maximum exposure: 24 cycle [each cycle = 14 days]) | The CBR was defined as the percentage of participants with a confirmed CR, PR, or SD lasting for at least 6 months. CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. SD: Sum of the diameters (longest for nonnodal lesions, shortest for nodal lesions) of target and new measurable lesions neither CR, PR, (compared to baseline) or PD (compared to nadir). |
| Secondary | Phase 2: Overall Survival | From date of randomization to the date of death (maximum exposure: 24 cycles [each cycle = 14 days]) | Overall survival was defined as the number of months from randomization to the date of death (due to any cause). |
| Secondary | Phase 2: Duration of Response | From start date of CR or PR to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) | Duration of response was defined as the number of months from the start date of PR or CR (whichever response occurred first) and subsequently confirmed, to the first date that recurrent or progressive disease was documented. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study .In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 2: Progression Free Survival (PFS), as Determined by the Local Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days]) | Full Analysis Set (FAS) included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | months | MEDIAN |
| PRIMARY | Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE) | Day 1 through Day 28 (Cycles 1 and 2) | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1b: Recommended Phase 2 Dose (RP2D) | Day 1 through Day 28 (Cycles 1 and 2) | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab. | mg | NUMBER |
| SECONDARY | Phase 2: PFS, as Determined by the Local Investigator Using Immune Response RECIST (irRECIST) | From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days]) | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | months | MEDIAN |
| SECONDARY | Phase 2: Objective Response Rate (ORR), as Assessed Using RECIST 1.1 | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: ORR, as Assessed Using irRECIST | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Clinical Benefit Rate (CBR), as Assessed Using RECIST 1.1 | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: CBR, as Assessed Using irRECIST | From date of randomization to date of progression (maximum exposure: 24 cycle [each cycle = 14 days]) | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Overall Survival | From date of randomization to the date of death (maximum exposure: 24 cycles [each cycle = 14 days]) | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | months | MEDIAN |
| SECONDARY | Phase 2: Duration of Response | From start date of CR or PR to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle and had a response (achieved objective response: complete response or partial response). | months | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 2: Progression Free Survival (PFS), as Determined by the Local Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Phase 2: Avelumab + Placebo | 1.51 | 95% Confidence Interval 1.45 to 2.50 | months | |
| Phase 2: Progression Free Survival (PFS), as Determined by the Local Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Phase 2: Avelumab + Entinostat | 1.64 | 95% Confidence Interval 1.41 to 2.69 | months | |
| Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE) | Phase 1B: Avelumab + Entinostat (3 mg) | 0 | Participants | ||
| Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE) | Phase 1B: Avelumab + Entinostat (5 mg) | 1 | Participants | ||
| Phase 1b: Recommended Phase 2 Dose (RP2D) | Phase 1B: Avelumab + Entinostat | 5 | mg | ||
| Phase 2: PFS, as Determined by the Local Investigator Using Immune Response RECIST (irRECIST) | Phase 2: Avelumab + Placebo | 2.10 | 95% Confidence Interval 1.45 to 2.79 | months | |
| Phase 2: PFS, as Determined by the Local Investigator Using Immune Response RECIST (irRECIST) | Phase 2: Avelumab + Entinostat | 1.77 | 95% Confidence Interval 1.45 to 2.69 | months | |
| Phase 2: Objective Response Rate (ORR), as Assessed Using RECIST 1.1 | Phase 2: Avelumab + Placebo | 4.88 | 95% Confidence Interval 0.60 to 16.53 | percentage of participants | |
| Phase 2: Objective Response Rate (ORR), as Assessed Using RECIST 1.1 | Phase 2: Avelumab + Entinostat | 5.88 | 95% Confidence Interval 1.94 to 13.20 | percentage of participants | |
| Phase 2: ORR, as Assessed Using irRECIST | Phase 2: Avelumab + Placebo | 2.44 | 95% Confidence Interval 0.06 to 12.86 | percentage of participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Determination Phase (Phase 1B) | STARTED | Phase 1B: Avelumab + Entinostat (3 mg) | 6 | |
| Dose Determination Phase (Phase 1B) | STARTED | Phase 1B: Avelumab + Entinostat (5 mg) | 8 | |
| Dose Determination Phase (Phase 1B) | STARTED | Phase 2: Avelumab + Placebo | 0 | |
| Dose Determination Phase (Phase 1B) | STARTED | Phase 2: Avelumab + Entinostat | 0 | |
| Dose Determination Phase (Phase 1B) | Received At Least 1 Dose Of Study Drug | Phase 1B: Avelumab + Entinostat (3 mg) | 6 | |
| Dose Determination Phase (Phase 1B) | Received At Least 1 Dose Of Study Drug | Phase 1B: Avelumab + Entinostat (5 mg) | 8 | |
| Dose Determination Phase (Phase 1B) | Received At Least 1 Dose Of Study Drug | Phase 2: Avelumab + Placebo | 0 | |
| Dose Determination Phase (Phase 1B) | Received At Least 1 Dose Of Study Drug | Phase 2: Avelumab + Entinostat | 0 | |
| Dose Determination Phase (Phase 1B) | Dose-limiting Toxicity (DLT) Evaluable | Phase 1B: Avelumab + Entinostat (3 mg) | 6 | |
| Dose Determination Phase (Phase 1B) | Dose-limiting Toxicity (DLT) Evaluable | Phase 1B: Avelumab + Entinostat (5 mg) | 8 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events720
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Phase 1B: Avelumab + Entinostat (3 mg) | 2 | 6 | |
| other | Nausea | Gastrointestinal disorders | Phase 1B: Avelumab + Entinostat (5 mg) | 6 | 8 | |
| other | Nausea | Gastrointestinal disorders | Phase 2: Avelumab + Placebo | 15 | 40 | |
| other | Nausea | Gastrointestinal disorders | Phase 2: Avelumab + Entinostat | 37 | 85 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase 1B: Avelumab + Entinostat (3 mg) | 3 | 6 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase 1B: Avelumab + Entinostat (5 mg) | 2 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase 2: Avelumab + Placebo | 11 | 40 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase 2: Avelumab + Entinostat | 34 | 85 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1B: Avelumab + Entinostat (3 mg) | 2 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1B: Avelumab + Entinostat (5 mg) | 1 | 8 |
1 to 10 of 720Source ClinicalTrials.gov
See all 720 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1B: Avelumab + Entinostat (3 mg) | 5 | 6 |
| Total, all-cause mortality | Phase 1B: Avelumab + Entinostat (5 mg) | 4 | 8 |
| Total, all-cause mortality | Phase 2: Avelumab + Placebo | 26 | 41 |
| Total, all-cause mortality | Phase 2: Avelumab + Entinostat | 54 | 85 |
| Total, other adverse events | Phase 1B: Avelumab + Entinostat (3 mg) | 6 | 6 |
| Total, other adverse events | Phase 1B: Avelumab + Entinostat (5 mg) | 8 | 8 |
| Total, other adverse events | Phase 2: Avelumab + Placebo | 39 | 40 |
| Total, other adverse events | Phase 2: Avelumab + Entinostat | 85 | 85 |
| Total, serious adverse events | Phase 1B: Avelumab + Entinostat (3 mg) | 0 | 6 |
| Total, serious adverse events | Phase 1B: Avelumab + Entinostat (5 mg) | 4 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase 1B: Avelumab + Entinostat (3 mg) vs Phase 1B: Avelumab + Entinostat (5 mg): Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02915523
GET https://conductscience.org/api/trials/v1/NCT02915523/results?page=2