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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2020-11-20

Brief Summary

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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).

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Detailed Description

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Conditions

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Metastatic Cholangiocarcinoma Cholangiocarcinoma Pancreatic Cancer Metastatic Pancreatic Cancer Unresectable Pancreatic Cancer Unresectable Cholangiocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A - Cholangiocarcinoma

Group Type EXPERIMENTAL

Entinostat

Intervention Type DRUG

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

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Entinostat

Intervention Type DRUG

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

Intervention Type DRUG

After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).

Interventions

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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).

Intervention Type DRUG

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).

Intervention Type DRUG

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).

Intervention Type DRUG

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).

Intervention Type DRUG

Other Intervention Names

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SNDX-275 OPDIVO, BMS-936558, MDX1106, ONO-4538 SNDX-275 OPDIVO, BMS-936558, MDX1106, ONO-4538

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years.
2. Have histologically or cytologically proven cholangiocarcinoma or adenocarcinoma of the pancreas that is metastatic or unresectable.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
4. Life expectancy of greater than 12 weeks.
5. Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
6. Woman of child bearing potential must have a negative pregnancy test.
7. Must have progressive measurable disease.
8. Must have an accessible non-bone tumor that can be biopsied.
9. Must use acceptable form of birth control while on study.
10. Willing to provide tissue and blood samples.
11. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

1. Chemotherapy, radiotherapy, investigational therapy, or surgery less than 3 weeks prior to trial registration
2. Prior treatment with epigenetic therapy (such as entinostat, panobinostat, vorinostat, romidepsin, 5-azacitidine, or decitabine)
3. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
4. Hypersensitivity reaction to any monoclonal antibody.
5. History of any autoimmune disease: inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis). Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
6. Have significant and/or malignant pleural effusion
7. Has a pulse oximetry \< 92% on room air.
8. Known history or evidence of brain metastases.
9. Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
10. Are pregnant or breastfeeding.
11. Infection with HIV or hepatitis B or C.
12. Patients on immunosuppressive agents.
13. Requiring concurrent administration of valproic acid.
14. Patients with diverticulitis, intra-abdominal abscess, or GI obstruction
15. Any contraindication to oral agents.
16. Another active malignancy ≤ 3 years prior to registration with the exception of non-melanotic skin cancer or carcinoma-in-situ of any type.
17. Unwilling or unable to follow the study schedule for any reason.
18. Evidence of ascites on imaging.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No