Epithelial Ovarian CancerPhase 1/2NCT02915523
Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer
A Phase 1/2 study testing entinostat and avelumab in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by Syndax Pharmaceuticals at 12 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- entinostat and avelumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 Dec 2016to 21 Apr 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer
- Recurrent or progressive disease on or after initial platinum-based chemotherapy
- Evidence of measurable disease based on imaging studies within 28 days before the first dose of study drug
- Previously received at least 3, but no more than 6, lines of therapy including at least 1 course of platinum-based therapy
- Participant must have acceptable, applicable laboratory requirements
- Participants may have a history of brain metastasis provided certain protocol criteria are met
- Experienced resolution of toxic effect(s) of the most recent prior anti-cancer therapy to Grade ≤1 (except alopecia or neuropathy)
- Able to understand and give written informed consent and comply with study procedures.
Who cannot join
- Non-epithelial ovarian carcinomas or ovarian tumors with low malignant potential (i.e., borderline tumors)
- Another known malignancy that is progressing or requires active treatment (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Previously treated with a histone deacetylase inhibitor (i.e., vorinostat, belinostat, romidepsin, panobinostat), PD-1/PD-L1-blocking antibody (i.e., atezolizumab, nivolumab, pembrolizumab), or a cytotoxic T-lymphocyte associated protein-4 (CTLA-4) agent
- Currently enrolled in (or completed) another investigational drug study within 30 days prior to study drug administration
- A medical condition that precludes adequate study treatment or increases participant risk
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22908
University of Chicago
Chicago, Illinois, 60637
HCA Midwest Health (SCRI Affiliate)
Kansas City, Missouri, 64131
Sarah Cannon Research Institute
Nashville, Tennessee, 37204
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
H. Lee Moffitt Cancer Center and Research
Tampa, Florida, 33612
Florida Cancer Specialist East Region (SCRI Affiliate)
West Palm Beach, Florida, 33401
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients With Advanced Epithelial Ovarian Cancer Which Has Progressed or Recurred After First-line Platinum-based Chemotherapy and at Least Two Subsequent Lines of Treatment With a Safety Lead-in
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.
Read the detailed description
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.
- Being tested
- entinostat, avelumab, Placebo
- Keywords
- Ovarian Cancer, Histone Deacetylase Inhibitors, Entinostat, Solid tumor, Avelumab, SNDX-275, Ovarian Neoplasms, Ovarian Diseases, Fallopian Tube Cancer, Peritoneal Cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms, Ovarian Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
entinostatDrug
Also called SNDX-275, MS-275
An orally available histone deacetylases inhibitor (HDACi).
avelumabDrug
Also called MSB0010718C
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.
PlaceboDrug
A pill containing no active drug ingredient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: entinostat; Drug: avelumab |
| 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. Receives: Drug: avelumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 through Day 28 (Cycles 1 and 2)
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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'.
Measured: 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
Measured: Pre-dose and post-infusion on Day 1 of Cycle 1 the 30-day follow-up (maximum exposure: 24 cycles [each cycle = 14 days])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start19 Dec 2016
- Primary completion21 Feb 2019
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany, Pfizer
- Responsible party
- Sponsor
- Investigators
- Michael Meyers, MD, PhD, Study director, Syndax PharmaceuticalsUrsula Matulonis, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915523
- Sponsor's protocol ID
- SNDX-275-0603
- Status last verified
- Dec 2023
- First submitted
- 14 Sep 2016
- Last updated
- 10 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients With Advanced Epithelial Ovarian Cancer Which Has Progressed or Recurred After First-line Platinum-based Chemotherapy and at Least Two Subsequent Lines of Treatment With a Safety Lead-in
- ClinicalTrials.gov ID
- NCT02915523
- Acronym / sponsor ID
- SNDX-275-0603
- Keywords
- Ovarian Cancer, Histone Deacetylase Inhibitors, Entinostat, Solid tumor, Avelumab, SNDX-275, Ovarian Neoplasms, Ovarian Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Syndax PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany, Pfizer
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Posted 10 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entinostat plus Avelumab | Active comparator | Drug: entinostat, Drug: avelumabAvelumab 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. |
| Placebo plus Avelumab | Placebo comparator | Drug: avelumab, Drug: PlaceboAvelumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer
- Recurrent or progressive disease on or after initial platinum-based chemotherapy
- Evidence of measurable disease based on imaging studies within 28 days before the first dose of study drug
- Previously received at least 3, but no more than 6, lines of therapy including at least 1 course of platinum-based therapy
- Participant must have acceptable, applicable laboratory requirements
Key exclusion criteria (7 listed)
- Non-epithelial ovarian carcinomas or ovarian tumors with low malignant potential (i.e., borderline tumors)
- Another known malignancy that is progressing or requires active treatment (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Previously treated with a histone deacetylase inhibitor (i.e., vorinostat, belinostat, romidepsin, panobinostat), PD-1/PD-L1-blocking antibody (i.e., atezolizumab, nivolumab, pembrolizumab), or a cytotoxic T-lymphocyte associated protein-4 (CTLA-4) agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| entinostatAlso: SNDX-275, MS-275An orally available histone deacetylases inhibitor (HDACi). | Drug | Entinostat plus Avelumab |
| avelumabAlso: MSB0010718CA 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. | Drug | Entinostat plus Avelumab, Placebo plus Avelumab |
| PlaceboA pill containing no active drug ingredient. | Drug | Placebo plus Avelumab |
Primary outcome
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)
Time frame: 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.
Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE)
Time frame: 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.
12 secondary outcomes
Phase 1b: Recommended Phase 2 Dose (RP2D)
Time frame: Day 1 through Day 28 (Cycles 1 and 2)
Phase 2: PFS, as Determined by the Local Investigator Using Immune Response RECIST (irRECIST)
Time frame: 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
Time frame: From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days])
Phase 2: ORR, as Assessed Using irRECIST
Time frame: 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
Time frame: From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days])
Phase 2: CBR, as Assessed Using irRECIST
Time frame: From date of randomization to date of progression (maximum exposure: 24 cycle [each cycle = 14 days])
Phase 2: Overall Survival
Time frame: From date of randomization to the date of death (maximum exposure: 24 cycles [each cycle = 14 days])
Phase 2: Duration of Response
Time frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose and post-infusion on Day 1 of Cycle 1 the 30-day follow-up (maximum exposure: 24 cycles [each cycle = 14 days])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Meyers, MD, PhD study director
Syndax Pharmaceuticals
Ursula Matulonis, MD principal investigator
Dana-Farber Cancer Institute
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing entinostat and avelumab in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by Syndax Pharmaceuticals at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days])). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.