← Back to Search

Epigenetic Modifier

Pembrolizumab for Mesothelioma

Phase 1 & 2

Waitlist Available

Led By David S Schrump, M.D.

Research Sponsored by National Cancer Institute (NCI)

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 every 10 weeks (± 1 week) until disease progression or unacceptable toxicity or off study criteria is met. longest participant on study 11 months.

Awards & highlights

Study Summary

This trial is studying a combination of 3 drugs as a possible treatment for non-small cell lung cancer.

Eligible Conditions

Mesothelioma
Non-Small Cell Lung Cancer
Lung Cancer
Esophageal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 10 weeks (± 1 week) until disease progression or unacceptable toxicity or off study criteria is met. longest participant on study 11 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 10 weeks (± 1 week) until disease progression or unacceptable toxicity or off study criteria is met. longest participant on study 11 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 10 weeks (± 1 week) until disease progression or unacceptable toxicity or off study criteria is met. longest participant on study 11 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of Decitabine

Maximum Tolerated Dose (MTD) of Tetrahydrouridine

Overall Response Rate

Secondary outcome measures

Changes in Circulating Tumor Cells (CTCs)

Changes in Gene, Endogenous Retroviral (ERV), Micro Ribonucleic Acid (RNA) Expressions, Deoxyribonucleic Acid (DNA) Methylation Signatures and Tumor Microenvironment

Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)

+1 more

Other outcome measures

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Number of Participants With a Dose Limiting Hematologic Toxicity (DLT)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2/Dose ExpansionExperimental Treatment3 Interventions

Decitabine (DAC)-Tetrahydrouridine (THU) + pembrolizumab at the dose established in Arm 1

Group II: 1/Dose EscalationExperimental Treatment3 Interventions

Decitabine (DAC)-Tetrahydrouridine (THU) + pembrolizumab at escalating doses

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine (DAC)

1995

Completed Phase 2

~30

Pembrolizumab

2017

Completed Phase 2

~2010

Tetrahydrouridine (THU)

1999

Completed Phase 1

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,872 Total Patients Enrolled

93 Trials studying Mesothelioma

8,645 Patients Enrolled for Mesothelioma

David S Schrump, M.D.Principal InvestigatorNational Cancer Institute (NCI)

18 Previous Clinical Trials

2,215 Total Patients Enrolled

10 Trials studying Mesothelioma

2,045 Patients Enrolled for Mesothelioma

Frequently Asked Questions

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

Are there still unfilled positions for volunteers in this experiment?

"That is accurate. According to the information on clinicaltrials.gov, this clinical trial is currently looking for 85 patients from 1 location. The trial was first posted on 4/11/2018 and was most recently updated on 10/4/2022."

Answered by AI

Pembrolizumab is often given to patients with what condition?

"Pembrolizumab can be used to target and treat patients with unresectable melanoma, microsatellite instability high, and high risk of recurrence."

Answered by AI

What other drugs has Pembrolizumab been tested against in a clinical setting?

"As of now, 1101 clinical trials for Pembrolizumab are underway, with 138 of them being Phase 3 trials. While some of the Pembrolizumab studies are based in Houston, Texas, there are 37420 different locations running Pembrolizumab trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas

David Schrump, M.D. 2018. "Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03233724.