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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
| Pfizer | INDUSTRY |
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The purpose of this study is to determine the biologically active dose of entinostat, when given in combination with avelumab, that is safe and warrants further investigation. Additionally, this study will evaluate the effectiveness of entinostat in combination with avelumab at the determined dose in terms of progression free survival compared to avelumab plus placebo in participants with refractory or recurrent epithelial ovarian cancer.
The study is comprised of 2 phases: an open-label Safety Lead-in (Phase 1b) followed by an Expansion Phase (Phase 2). The Expansion Phase will evaluate the efficacy and safety of entinostat with avelumab when administered at the Recommended Phase 2 Dose (RP2D) versus avelumab alone in participants with advanced epithelial ovarian cancer in a randomized, double-blind, placebo-controlled setting. In Phase 2, participants will be randomized in a 2:1 ratio to receive avelumab plus entinostat or avelumab plus placebo, respectively.
All participants will be assessed at Screening and at specified times during the conduct of the study using standard clinical and laboratory assessments. Participants will be assessed for response through radiological assessments. Participants will continue receiving their appropriate cycles of study treatment until tumor progression or adverse events (AEs) occur which necessitate discontinuing therapy as determined by the Investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entinostat plus Avelumab | Active Comparator | Avelumab is administered intravenously (IV) on Day 1 of each 14-day cycle in combination with Entinostat administration on Day 1 and Day 8 of each cycle at the Maximum tolerated Dose (MTD)/RP2D as determined in the Phase Ib (Dose Determination) part of the study. |
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| Placebo plus Avelumab | Placebo Comparator | Avelumab is administered intravenously (IV) on Day 1 of each 14-day cycle in combination with placebo administered on Day 1 and Day 8 of each cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| entinostat | Drug | An orally available histone deacetylases inhibitor (HDACi). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days]) |
| Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE) | 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. | Day 1 through Day 28 (Cycles 1 and 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Recommended Phase 2 Dose (RP2D) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Meyers, MD, PhD | Syndax Pharmaceuticals | Study Director |
| Ursula Matulonis, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research | Tampa | Florida | 33612 | United States | ||
| Florida Cancer Specialist East Region (SCRI Affiliate) |
An independent data safety monitoring board (DSMB) will be established for the Phase 2 portion of this study to act in an advisory capacity to the Sponsor with respect to safeguarding the interests of trial patients and assessing the safety of the interventions administered during the trial.
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The study comprised 2 phases: an open-label Safety Lead-in (Phase 1b) and an Expansion Phase (Phase 2). Eligible participants were enrolled into Phase 1b or randomized into Phase 2 of the study within 3 days prior to starting study treatment on Cycle 1, Day 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1B: Avelumab + Entinostat (3 mg) | Participants received entinostat 3 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab intravenously (IV) once every 2 weeks (Day 1 of each 14-day cycle). |
| FG001 | Phase 1B: Avelumab + Entinostat (5 mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Determination Phase (Phase 1B) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2017 | Aug 4, 2023 |
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| avelumab | Drug | A fully human antibody of the immunoglobulin (Ig) G1 isotype that targets and blocks Programmed death-ligand 1 (PD-L1), the ligand for Programmed cell death protein 1 (PD-1) receptor. |
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| Placebo | Drug | A pill containing no active drug ingredient. |
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| Day 1 through Day 28 (Cycles 1 and 2) |
| Phase 2: PFS, as Determined by the Local Investigator Using Immune Response RECIST (irRECIST) | 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. | From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days]) |
| Phase 2: Objective Response Rate (ORR), as Assessed Using RECIST 1.1 | 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. | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) |
| Phase 2: ORR, as Assessed Using irRECIST | 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%. | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) |
| Phase 2: Clinical Benefit Rate (CBR), as Assessed Using RECIST 1.1 | 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. | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) |
| Phase 2: CBR, as Assessed Using irRECIST | 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). | From date of randomization to date of progression (maximum exposure: 24 cycle [each cycle = 14 days]) |
| Phase 2: Overall Survival | Overall survival was defined as the number of months from randomization to the date of death (due to any cause). | From date of randomization to the date of death (maximum exposure: 24 cycles [each cycle = 14 days]) |
| Phase 2: Duration of Response | 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. | From start date of CR or PR to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) |
| Phase 2: Time to Response | Time to response was defined as the number of months from the randomization date to the first date the participant achieved a PR or CR (whichever response occurred first and was subsequently confirmed). 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. | From the date of randomization to date of PR or CR (maximum exposure: 24 cycles [each cycle = 14 days]) |
| Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death | An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that started on or after the first administration of study drug and within 30 days of the last administration of any study treatment. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days]) |
| Phase 2: Number of Participants With TEAEs, SAEs, AEs Resulting in the Permanent Discontinuation of Study Drug, and Death | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that started on or after the first administration of study drug and within 30 days of the last administration of any study treatment. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days]) |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Avelumab When Given in Combination With Entinostat | Pre-dose and post-infusion on Day 1 of Cycle 1 the 30-day follow-up (maximum exposure: 24 cycles [each cycle = 14 days]) |
| West Palm Beach |
| Florida |
| 33401 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| HCA Midwest Health (SCRI Affiliate) | Kansas City | Missouri | 64131 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37204 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
Participants received entinostat 5 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). |
| FG002 | Phase 2: Avelumab + Placebo | Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). |
| FG003 | Phase 2: Avelumab + Entinostat | Participants received entinostat at the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). |
| Received At Least 1 Dose Of Study Drug |
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| Dose-limiting Toxicity (DLT) Evaluable | Participants who received at least one dose of entinostat or avelumab were evaluated for DLTs over 2 cycles (Cycle 1 and Cycle 2). |
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| COMPLETED |
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| NOT COMPLETED |
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| Expansion Phase (Phase 2) |
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All participants who were enrolled in Phase 1B and randomized in Phase 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1B: Avelumab + Entinostat (3 mg) | Participants received entinostat 3 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). |
| BG001 | Phase 1B: Avelumab + Entinostat (5 mg) | Participants received entinostat 5 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). |
| BG002 | Phase 2: Avelumab + Placebo | Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). |
| BG003 | Phase 2: Avelumab + Entinostat | Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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) | 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. | Full Analysis Set (FAS) included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | Posted | Median | 95% Confidence Interval | months | From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days]) |
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| Primary | Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE) | 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. | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab. | Posted | Count of Participants | Participants | Day 1 through Day 28 (Cycles 1 and 2) |
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| Secondary | Phase 1b: Recommended Phase 2 Dose (RP2D) | 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. | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab. | Posted | Number | mg | Day 1 through Day 28 (Cycles 1 and 2) |
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| Secondary | Phase 2: PFS, as Determined by the Local Investigator Using Immune Response RECIST (irRECIST) | 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. | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | Posted | Median | 95% Confidence Interval | months | From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days]) |
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| Secondary | Phase 2: Objective Response Rate (ORR), as Assessed Using RECIST 1.1 | 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. | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) |
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| Secondary | Phase 2: ORR, as Assessed Using irRECIST | 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%. | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) |
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| Secondary | Phase 2: Clinical Benefit Rate (CBR), as Assessed Using RECIST 1.1 | 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. | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) |
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| Secondary | Phase 2: CBR, as Assessed Using irRECIST | 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). | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to date of progression (maximum exposure: 24 cycle [each cycle = 14 days]) |
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| Secondary | Phase 2: Overall Survival | Overall survival was defined as the number of months from randomization to the date of death (due to any cause). | FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle. | Posted | Median | 95% Confidence Interval | months | From date of randomization to the date of death (maximum exposure: 24 cycles [each cycle = 14 days]) |
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| Secondary | Phase 2: Duration of Response | 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. | 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). | Posted | Median | 95% Confidence Interval | months | From start date of CR or PR to date of progression (maximum exposure: 24 cycles [each cycle = 14 days]) |
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| Secondary | Phase 2: Time to Response | Time to response was defined as the number of months from the randomization date to the first date the participant achieved a PR or CR (whichever response occurred first and was subsequently confirmed). 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. | 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). | Posted | Median | 95% Confidence Interval | months | From the date of randomization to date of PR or CR (maximum exposure: 24 cycles [each cycle = 14 days]) |
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| Secondary | Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death | An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that started on or after the first administration of study drug and within 30 days of the last administration of any study treatment. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab. | Posted | Count of Participants | Participants | From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days]) |
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| Secondary | Phase 2: Number of Participants With TEAEs, SAEs, AEs Resulting in the Permanent Discontinuation of Study Drug, and Death | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that started on or after the first administration of study drug and within 30 days of the last administration of any study treatment. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab. | Posted | Count of Participants | Participants | From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days]) |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Avelumab When Given in Combination With Entinostat | Analysis was not performed as data were not collected for this outcome measure. | Posted | Pre-dose and post-infusion on Day 1 of Cycle 1 the 30-day follow-up (maximum exposure: 24 cycles [each cycle = 14 days]) |
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From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1B: Avelumab + Entinostat (3 mg) | Participants received entinostat 3 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). | 5 | 6 | 0 | 6 | 6 | 6 |
| EG001 | Phase 1B: Avelumab + Entinostat (5 mg) | Participants received entinostat 5 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). | 4 | 8 | 4 | 8 | 8 | 8 |
| EG002 | Phase 2: Avelumab + Placebo | Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). | 26 | 41 | 17 | 40 | 39 | 40 |
| EG003 | Phase 2: Avelumab + Entinostat | Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). | 54 | 85 | 39 | 85 | 85 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Myasthenic syndrome | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Congenital, familial and genetic disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cystitis klebsiella | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Connective tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Steroid withdrawal syndrome | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
|
Publication of the results of the multi-center Study shall not be made before the first multi-site publication by Sponsor or Publications Committee. No Public Presentation by Institution or Investigator will be made until Study Documentation/Results from all sites are received and analyzed by Sponsor. Separate publication by Investigator will be delayed for a period of 18 months until the initial publication by Committee or Sponsor, or a determination is made not to make such publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Madigan, MD, Chief Medical Officer | Syndax Pharmaceuticals, Inc. | 858-888-3798 | kmadigan@syndax.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2018 | Aug 4, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C118739 | entinostat |
| C000609138 | avelumab |
Not provided
Not provided
Not provided
| Sponsor Decision |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| ≥65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
| Phase 2: Avelumab + Entinostat |
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). |
|
|
|
|
| Phase 1B: Avelumab + Entinostat (5 mg) |
Participants received entinostat 5 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). |
|
|
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle). |
|
|