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

Brief summary public domain (ClinicalTrials.gov)

The proposed study is an open-label, two-arm study of entinostat plus nivolumab in patients with unresectable or metastatic cholangiocarcinoma (CCA) or pancreatic ductal adenocarcinoma (PDAC).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) [27 months]. Count Of Participants, Participants. Arm A - Cholangiocarcinoma (n=13): 0; ARM B - Pancreatic Cancer (n=27): 3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Patients Experiencing a Grade 3 or Above Treatment-related Adverse Event (AE) [29 months]. Count Of Participants, Participants. Arm A - Cholangiocarcinoma (n=13): 5; ARM B - Pancreatic Cancer (n=30): 19.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [38 months]. Median, months (95% Confidence Interval). Arm A - Cholangiocarcinoma (n=13): 6.378 (3.748 to NA) [Upper bound confidence interval was not reached.]; ARM B - Pancreatic Cancer (n=30): 2.729 (1.84 to 5.62).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) at 6 Months [6 months]. Number, proportion of participants (95% Confidence Interval). Arm A - Cholangiocarcinoma (n=13): 0.538 (0.326 to 0.891); ARM B - Pancreatic Cancer (n=30): 0.277 (0.153 to 0.498).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) at 12 Months [12 months]. Number, proportion of participants (95% Confidence Interval). Arm A - Cholangiocarcinoma (n=13): 0.308 (0.136 to 0.695); ARM B - Pancreatic Cancer (n=30): 0.138 (0.056 to 0.343).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) at 24 Months [24 months]. Number, proportion of participants (95% Confidence Interval). Arm A - Cholangiocarcinoma (n=13): 0.077 (0.012 to 0.506); ARM B - Pancreatic Cancer (n=30): 0.035 (0.005 to 0.237).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) at 36 Months [36 months]. Number, proportion of participants (95% Confidence Interval). Arm A - Cholangiocarcinoma (n=13): 0.077 (0.012 to 0.506); ARM B - Pancreatic Cancer (n=30): 0.035 (0.005 to 0.237).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response (DOR) [27 months]. Median, months (Full Range). ARM B - Pancreatic Cancer (n=3): 10.2 (3.7 to 17.9).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) at 6 Months [6 months]. Number, proportion of participants (95% Confidence Interval). Arm A - Cholangiocarcinoma (n=13): 0 (NA to NA) [All patients progressed by 6 months]; ARM B - Pancreatic Cancer (n=30): 0.067 (0.017 to 0.254).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) at 12 Months [12 months]. Number, proportion of participants (95% Confidence Interval). Arm A - Cholangiocarcinoma (n=13): 0 (NA to NA) [All patients progressed by 12 months.]; ARM B - Pancreatic Cancer (n=30): 0.067 (0.017 to 0.254).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) at 24 Months [24 months]. Number, proportion of participants (95% Confidence Interval). Arm A - Cholangiocarcinoma (n=13): 0 (NA to NA) [All patients progressed by 24 months]; ARM B - Pancreatic Cancer (n=30): 0 (NA to NA) [All patients progressed by 24 months].