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Epigenetic Modifiers

Nivolumab for Non-Small Cell Lung Cancer (NA_00084192 Trial)

Phase 2
Waitlist Available
Led By Julie Brahmer, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

NA_00084192 Trial Summary

This trial's response rate was 36%.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Epigenetic Therapy

NA_00084192 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response
Secondary outcome measures
Overall survival
Progression free survival
Safety and tolerability as assessed by number of participants with adverse events
+1 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

NA_00084192 Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm FExperimental Treatment3 Interventions
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.
Group II: Arm EExperimental Treatment3 Interventions
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.
Group III: Arm DExperimental Treatment3 Interventions
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.
Group IV: Arm CExperimental Treatment1 Intervention
Nivolumab 3mg/kg every 2 weeks until progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Entinostat
2017
Completed Phase 2
~1170
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Syndax Pharmaceuticals, Inc.UNKNOWN
4 Previous Clinical Trials
74 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,799 Total Patients Enrolled
Rising Tide FoundationOTHER
13 Previous Clinical Trials
4,126 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research open to elderly participants exceeding the age of seventy?

"This clinical trial requires patients to be between 18 and 100 years of age in order to participate. However, there are separate trials available for people below the legal age (115 studies) as well those above retirement age (2,911 studies)."

Answered by AI

Is there room for additional participants in this investigation?

"This medical trial has concluded its recruitment phase, having been posted on August 1st 2013 and last edited on the same date in 2022. If you are seeking to participate in another study, there are presently 2041 studies recruiting patients with lung cancer and 898 studies enrolling individuals taking Nivolumab."

Answered by AI

Has Nivolumab been sanctioned by the FDA for clinical use?

"We rate the safety of Nivolumab at 2 on a scale of 1 to 3 due to Phase 2 clinical data implying its safety, yet lacking sufficient evidence regarding its efficacy."

Answered by AI

Could you outline the other research endeavors involving Nivolumab?

"Nivolumab was initially investigated at the Chinese University of Hong Kong-Prince of Wales Hospital in 2006, since which time 437 studies have been completed. At present, 898 trials are actively seeking participants; a great many of these being held within Los Angeles, California."

Answered by AI

What medical purposes is Nivolumab typically employed for?

"Nivolumab is a viable therapeutic option for patients suffering from induction chemotherapy, malignant neoplasms, and acute myelocytic leukemia."

Answered by AI

Are there numerous medical centers testing this experiment in North America?

"This medical research is taking place at the University of Southern California in Los Angeles, Johns Hopkins in Pittsburgh, and UPMC Cancer Center- Hillman Cancer Center in Washington DC. Additionally, there are 2 other sites which are currently participating as well."

Answered by AI

Am I eligible to partake in this medical study?

"This clinical trial requires one hundred and one participants with lung cancer between 18 to 100 years old. They must meet the following criteria: age greater than 18, willingness to sign a written informed consent document, histologically proven stage IIIB, IV or recurrent non-small cell lung cancer, measurable disease of at least 20mm in length/width (10 mm for spiral CT scan), ECOG performance status 0 - 1, life expectancy exceeding 12 weeks, adequate organ and marrow function, agreement to use contraception prior to study entry until 23 weeks after nivolumab treatment ends for women and 31 weeks after last dose of nivolum"

Answered by AI

How many participants have been enlisted for this research endeavor?

"At this point in time, the current trial is not recruiting. The advertisement was issued on August 1st 2013 and adjusted lastly on August 1st 2022. Presently there are 2041 clinical trials accepting patients with lung cancer diagnosis and 898 studies that focus specifically on Nivolumab actively searching for volunteers."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.
2013. "Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01928576.
~9 spots leftby Apr 2025
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