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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
Pretreatment tissue should be collected via core biopsy, ideally of a non-target lesion
Histologically-confirmed stage IIIb or IV NSCLC by the enrolling institution
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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My cancer tissue sample was taken through a core biopsy.
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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 blood, kidney, and liver functions are within normal ranges.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
number of patients with adverse events
response rate (Phase Ib)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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
~570
Mocetinostat
2016
Completed Phase 2
~270
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,780 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,672 Total Patients Enrolled
Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,937 Total Patients Enrolled

Media Library

Guadecitabine (Epigenetic Modifier) Clinical Trial Eligibility Overview. Trial Name: NCT03220477 — Phase 1
Lung Cancer Research Study Groups: pembrolizumab plus guadecitabine and mocetinostat
Lung Cancer Clinical Trial 2023: Guadecitabine Highlights & Side Effects. Trial Name: NCT03220477 — Phase 1
Guadecitabine (Epigenetic Modifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03220477 — Phase 1

Frequently Asked Questions

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

When was Pembrolizumab cleared by the FDA?

"Pembrolizumab received a score of 1 because, at this stage in development, there is only minimal data supporting both its efficacy and safety."

Answered by AI

What is the most popular disease that Pembrolizumab is used to fight?

"Pembrolizumab is most often used to fight cancerous growths. Additionally, it has shown to be effective in treating unresectable melanoma, microsatellite instability high, and chemotherapy-resistant disease progression."

Answered by AI

What is the target number of people that will be participating in this clinical trial?

"This study is no longer recruiting patients for participation. It was initially posted on 8/4/2017, with the last update on 10/28/2022. However, there are 1667 other trials for patients with lung cancer and 1008 for Pembrolizumab that are actively recruiting patients."

Answered by AI

What other investigations have been made into Pembrolizumab?

"City of Hope was the first to study pembrolizumab in 2010 and, since then, there have been 275 completed trials. There are currently 1008 active trials being conducted, a fair few of which are based in Baltimore, Maryland."

Answered by AI
~1 spots leftby Jul 2024