Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 14 of 14

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
SECONDARY	Phase 2: Time to Response	From the date of randomization to date of PR or CR (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
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	From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])	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 2: Number of Participants With TEAEs, SAEs, AEs Resulting in the Permanent Discontinuation of Study Drug, and Death	From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])	Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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])	Analysis was not performed as data were not collected for this outcome measure.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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GET https://conductscience.org/api/trials/v1/NCT02915523/outcomes

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