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Epigenetic Modifier
Pembrolizumab + Epigenetic Drugs for Lung Cancer
Phase 1
Waitlist Available
Led By Kathryn Arbour, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically-confirmed stage IIIb or IV NSCLC by the enrolling institution
Patient must be capable, willing, and able to provide written, informed consent
Must not have
Active infection requiring systemic therapy
History of (non-infectious) pneumonitis that required steroids, or current pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of combining three drugs to treat cancer. Pembrolizumab will be given at a set dose, while guadecitabine and mocetinostat will be given at different doses to test their efficacy and side effects.
Who is the study for?
Adults over 18 with advanced stage IIIb or IV NSCLC who have previously been treated with anti-PD1/PD-L1 therapy and experienced disease progression. Participants must be able to undergo biopsies, have an ECOG performance status of 0-1, and adequate organ function. Women must test negative for pregnancy and use effective contraception.
What is being tested?
The trial is testing the safety of combining pembrolizumab (an immunotherapy drug) with guadecitabine and mocetinostat (epigenetic drugs). The goal is to determine the effects on lung cancer treatment and identify any side effects at various doses.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in different body parts, infusion-related reactions, fatigue, changes in blood counts or liver/kidney functions. Specific side effect profiles for guadecitabine and mocetinostat will also be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is at stage IIIb or IV.
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I am able and willing to sign the consent form.
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I am 18 years old or older.
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My condition worsened despite treatment with anti-PD1/PD-L1 drugs.
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I am willing to have a biopsy before and during treatment.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on medication for an infection.
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I have had pneumonitis treated with steroids or have it now.
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I have been diagnosed with tuberculosis in the past.
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I stopped a PD-1/PD-L1 therapy due to an immune-related side effect.
Select...
I have brain metastases that have not been treated.
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I have a heart condition.
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I have had lung conditions that needed steroid treatment.
Select...
My cancer has specific changes in the EGFR gene or ALK rearrangements.
Select...
I have not received a live vaccine in the last 30 days.
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I have been diagnosed with an immune system disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
number of patients with adverse events
response rate (Phase Ib)
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: pembrolizumab plus guadecitabine and mocetinostatExperimental Treatment3 Interventions
Pembrolizumab given IV; guadecitabine given SQ, mocetinostat given PO.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guadecitabine
2014
Completed Phase 3
~730
Mocetinostat
2013
Completed Phase 2
~60
Pembrolizumab
2017
Completed Phase 3
~3130
Find a Location
Who is running the clinical trial?
Mirati Therapeutics Inc.Industry Sponsor
70 Previous Clinical Trials
8,101 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,773 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,810 Total Patients Enrolled
Stand Up To CancerOTHER
52 Previous Clinical Trials
40,093 Total Patients Enrolled
Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,497 Total Patients Enrolled
Van Andel Research InstituteOTHER
27 Previous Clinical Trials
5,161 Total Patients Enrolled
Kathryn Arbour, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication for an infection.You have a history of autoimmune disease.I do not have another cancer that is getting worse or needs treatment now.You have a positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV), indicating an ongoing infection.My cancer tissue sample was taken through a core biopsy.My lung cancer is at stage IIIb or IV.I have had pneumonitis treated with steroids or have it now.I have recovered from side effects of my previous cancer treatment.I have not been treated with platinum-based chemotherapy and my condition is not expected to worsen significantly within the next 12 weeks.I haven't had radiation therapy outside the brain within a week before starting the study treatment.I have been diagnosed with tuberculosis in the past.I am able and willing to sign the consent form.I stopped a PD-1/PD-L1 therapy due to an immune-related side effect.I have brain metastases that have not been treated.I have not had a stroke or mini-stroke in the last 6 months.I have a heart condition.I have had lung conditions that needed steroid treatment.I haven't taken immunosuppressive drugs in the last 7 days.I am 18 years old or older.My blood, kidney, and liver functions are within normal ranges.My cancer has specific changes in the EGFR gene or ALK rearrangements.My condition worsened despite treatment with anti-PD1/PD-L1 drugs.I am willing to have a biopsy before and during treatment.Your condition can be measured using a specific set of guidelines called RECIST v1.1.You have tested positive for HIV antibodies and/or RNA.I have not received a live vaccine in the last 30 days.I haven't had any cancer treatments in the last 3 weeks.I have been diagnosed with an immune system disorder.You have had an organ transplant from someone else.I am fully active or can carry out light work.Women who could become pregnant must have a negative pregnancy test within 28 days before starting the study.You are using reliable birth control.
Research Study Groups:
This trial has the following groups:- Group 1: pembrolizumab plus guadecitabine and mocetinostat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.