Trial Outcomes & Findings for A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma (NCT NCT03250273)

Last Updated: 2025-05-28

Results Overview

Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Subjects who discontinue due to clinical progression prior to post-baseline tumor assessments were considered as non-responders.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

27 months

Results posted on

2025-05-28

Participant Flow

1 enrolled participant withdrew consent prior to initiating treatment

Participant milestones

Participant milestones
Measure	Arm A - Cholangiocarcinoma Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Overall Study STARTED	13	30
Overall Study COMPLETED	11	18
Overall Study NOT COMPLETED	2	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A - Cholangiocarcinoma Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Overall Study Disease Progression	2	11
Overall Study Death	0	1

Baseline Characteristics

A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	27 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	28 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	30 Participants n=7 Participants	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: 27 months

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=27 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 29 months

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Number of Patients Experiencing a Grade 3 or Above Treatment-related Adverse Event (AE)	5 Participants	19 Participants

SECONDARY outcome

Timeframe: 38 months

OS is defined as the duration of time from start of study treatment to time of death (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Overall Survival (OS)	6.378 months Interval 3.748 to Upper bound confidence interval was not reached.	2.729 months Interval 1.84 to 5.62

SECONDARY outcome

Timeframe: 6 months

OS is defined as the proportion of subjects who are alive at 6 months. Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Overall Survival (OS) at 6 Months	0.538 proportion of participants Interval 0.326 to 0.891	0.277 proportion of participants Interval 0.153 to 0.498

SECONDARY outcome

Timeframe: 12 months

OS is defined as the proportion of subjects who are alive at 12 months. Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Overall Survival (OS) at 12 Months	0.308 proportion of participants Interval 0.136 to 0.695	0.138 proportion of participants Interval 0.056 to 0.343

SECONDARY outcome

Timeframe: 24 months

OS is defined as the proportion of subjects who are alive at 24 months. Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Overall Survival (OS) at 24 Months	0.077 proportion of participants Interval 0.012 to 0.506	0.035 proportion of participants Interval 0.005 to 0.237

SECONDARY outcome

Timeframe: 36 months

OS is defined as the proportion of subjects who are alive at 36 months. Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Overall Survival (OS) at 36 Months	0.077 proportion of participants Interval 0.012 to 0.506	0.035 proportion of participants Interval 0.005 to 0.237

SECONDARY outcome

Timeframe: 27 months

Population: There were no responses (PR or CR) observed in Arm A; therefore, the number of analyzed participants is zero. 3 participants achieved response in Arm B.

Duration of response (DOR) will be calculated for subjects who achieve a best overall response of CR or PR. DOR is defined as the number of months from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions.

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=3 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Duration of Response (DOR)	—	10.2 months Interval 3.7 to 17.9

SECONDARY outcome

Timeframe: 6 months

PFS is defined as the proportion of patients without disease progression (PD or relapse from CR) or death due to any cause at 6 months. Disease progression will be assessed using RECIST (version 1.1). Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Progression Free Survival (PFS) at 6 Months	0 proportion of participants All patients progressed by 6 months	0.067 proportion of participants Interval 0.017 to 0.254

SECONDARY outcome

Timeframe: 12 months

PFS is defined as the proportion of patients without disease progression (PD or relapse from CR) or death due to any cause at 12 months. Disease progression will be assessed using RECIST (version 1.1). Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Progression Free Survival (PFS) at 12 Months	0 proportion of participants All patients progressed by 12 months.	0.067 proportion of participants Interval 0.017 to 0.254

SECONDARY outcome

Timeframe: 24 months

PFS is defined as the proportion of patients without disease progression (PD or relapse from CR) or death due to any cause at 24 months. Disease progression will be assessed using RECIST (version 1.1). Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Arm A - Cholangiocarcinoma n=13 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 Participants Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Progression Free Survival (PFS) at 24 Months	0 proportion of participants All patients progressed by 24 months	0 proportion of participants All patients progressed by 24 months

Adverse Events

Arm A - Cholangiocarcinoma

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

ARM B - Pancreatic Cancer

Serious events: 3 serious events

Other events: 27 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm A - Cholangiocarcinoma n=13 participants at risk Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 participants at risk Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Gastrointestinal disorders Colitis	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	3.3% 1/30 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 2 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	0.00% 0/30 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Infections and infestations Pneumonitis	15.4% 2/13 • Number of events 2 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	0.00% 0/30 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations Transaminitis	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	0.00% 0/30 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Metabolism and nutrition disorders Renal tubular acidosis	0.00% 0/13 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	3.3% 1/30 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/13 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	3.3% 1/30 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.

Other adverse events

Additional Information

Nilofer Azad, MD

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 410-614-9169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A - Cholangiocarcinoma n=13 participants at risk Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).	ARM B - Pancreatic Cancer n=30 participants at risk Entinostat: Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle). Nivolumab: After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
Blood and lymphatic system disorders Anemia	7.7% 1/13 • Number of events 2 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	30.0% 9/30 • Number of events 14 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Endocrine disorders Hypothyroidism	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	0.00% 0/30 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Constipation	15.4% 2/13 • Number of events 2 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	3.3% 1/30 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Diarrhea	15.4% 2/13 • Number of events 2 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	10.0% 3/30 • Number of events 4 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Dry lips	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	0.00% 0/30 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Early satiety	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	3.3% 1/30 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Dry mouth	0.00% 0/13 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	6.7% 2/30 • Number of events 2 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Mucositis oral	0.00% 0/13 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	13.3% 4/30 • Number of events 5 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Nausea	46.2% 6/13 • Number of events 8 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	33.3% 10/30 • Number of events 11 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Gastrointestinal disorders Vomiting	0.00% 0/13 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	20.0% 6/30 • Number of events 7 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
General disorders Chills	0.00% 0/13 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	6.7% 2/30 • Number of events 3 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
General disorders Edema	30.8% 4/13 • Number of events 4 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	13.3% 4/30 • Number of events 4 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
General disorders Fatigue	92.3% 12/13 • Number of events 18 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	66.7% 20/30 • Number of events 25 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
General disorders Fever	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	10.0% 3/30 • Number of events 7 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
General disorders Flu-like symptoms	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	0.00% 0/30 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Infections and infestations Thrush	15.4% 2/13 • Number of events 2 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	13.3% 4/30 • Number of events 4 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations Lymphocyte count decreased	15.4% 2/13 • Number of events 2 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	26.7% 8/30 • Number of events 15 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations Neutrophil count decreased	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	13.3% 4/30 • Number of events 6 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations Platelet count decreased	23.1% 3/13 • Number of events 8 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	10.0% 3/30 • Number of events 4 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Investigations White blood cell decreased	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	0.00% 0/30 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Metabolism and nutrition disorders Anorexia	38.5% 5/13 • Number of events 6 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	50.0% 15/30 • Number of events 17 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/13 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	10.0% 3/30 • Number of events 6 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Metabolism and nutrition disorders Hyponatremia	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	16.7% 5/30 • Number of events 5 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Metabolism and nutrition disorders Weight loss	0.00% 0/13 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	6.7% 2/30 • Number of events 2 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Nervous system disorders Dizziness	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	0.00% 0/30 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Nervous system disorders Dysgeusia	15.4% 2/13 • Number of events 2 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	6.7% 2/30 • Number of events 4 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Psychiatric disorders Insomnia	7.7% 1/13 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	0.00% 0/30 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Number of events 7 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	3.3% 1/30 • Number of events 1 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
Skin and subcutaneous tissue disorders Rash maculo-papular	23.1% 3/13 • Number of events 4 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.	13.3% 4/30 • Number of events 12 • 29 months Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.