Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Decitabine

Nivolumab

Cc-486

Entinostat

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antimetabolites

Enzyme Inhibitors

Histone Deacetylase Inhibitors

Nivolumab 3mg/kg every 2 weeks until progression

Anti-PD-1/PD-L1 treatment naïve patients only

Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression

After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.

Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.

Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression

After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.

Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.

Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression

After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.

Anti-PD-1/PD-L1 treatment naïve patients only Every 28 days for 2 cycles Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10 Entinostat 7mg by mouth Days 3 and 10

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg

Every 28 days for 2 cycles CC-486 300 mg by mouth days 1 - 21

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.

CC-486 300

Julie Brahmer, MD

Objective response rate to Nivolumab preceded by epigenetic priming. Response will be assessed by RECIST 1.1 criteria, baseline scans for this assessment will be the baseline scans done within 4 weeks of enrollment.

Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.

A Phase II Study of Epigenetic Therapy With Azacitidine and Entinostat With Concurrent Nivolumab in Subjects With Metastatic Non-Small Cell Lung Cancer.

Percentage of participants with response to combination Nivolumab and epigenetic therapy. Response will be assessed by RECIST 1.1 criteria, where complete response (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.

Number of months from the time of randomization until radiologic (per RECIST 1.1) or clinical progression or death, whichever comes first.

Number of months from the time nivolumab begins until radiologic (per RECIST 1.1) or clinical progression is noted.

Number of months from the time of randomization until death. Estimation will be by the Kaplan-Meier method.

Number of participants who experience adverse events as defined by CTCAE v4.0 that require a dose reduction.

Rising Tide Foundation

Stand Up To Cancer

Bristol-Myers Squibb

Celgene

Syndax Pharmaceuticals

Rhone-Poulenc Rorer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Anti-PD-1/PD-L1 treatment naïve patients only

Every 28 days for 2 cycles

Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10

Entinostat 7mg by mouth Days 3 and 10

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression

After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.

ARM A

Every 28 days for 2 cycles

CC-486 300 mg by mouth days 1 - 21

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression

After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.

ARM B

Nivolumab 3mg/kg every 2 weeks until progression

Nivolumab

Arm C

Anti-PD-1/PD-L1 treatment naïve patients only

Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression

After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.

Azacitidine

Entinostat

Nivolumab

Arm D

Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.

Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression

After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.

Azacitidine

Entinostat

Nivolumab

Arm E

Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.

Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression

After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.

Azacitidine

Entinostat

Nivolumab

Arm F

Anti-PD-1/PD-L1 treatment naïve patients only

Every 28 days for 2 cycles Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10 Entinostat 7mg by mouth Days 3 and 10

Followed by:

Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg.

Total

age data was missing for 1 participant in Arm F.

Age, Continuous

age data was missing for 1 participant in Arm F

Unknown

Female

Male

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Amber Michalik

1 patient from ARM A and 1 patient from ARM C did not have documentation of resict reads to analysis.

Spots Global Cancer Trial Database for Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial