- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02697630
Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye (PEMDAC)
December 1, 2023 updated by: Vastra Gotaland Region
A Multicenter Phase II Open Label Study to Evaluate Efficacy of Concomitant Use of Pembrolizumab and Entinostat in Adult Patients With Metastatic Uveal Melanoma
The purpose of this study is to see if the combination of entinostat and pembrolizumab can be an effective treatment for patients with melanoma of the eye (uveal melanoma) that has spread to other sites of the body (metastatic disease).
Pembrolizumab is an antibody that helps the immune system to attack cancer cells.
Although pembrolizumab has proven clinical efficacy in treating patients with metastatic cutaneous melanoma, an effect on metastatic uveal melanoma has not been established.
Entinostat is a histone deacetylase (HDAC) inhibitor that has effects on both cancer cells and immune regulatory cells, thus potentially enhancing the effects of immunotherapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Västra Götaland Region
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Gothenburg, Västra Götaland Region, Sweden, SE-413 45
- Department of Oncology, Sahlgrenska University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age above 18 years.
- Signed and dated written informed consent before the start of specific protocol procedures.
- ECOG PS 0-1
- Histologically/cytologically confirmed stage IV uveal melanoma
- Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
- Any number of prior therapies (including none), with the exception of anticancer immunotherapy
Exclusion Criteria:
- Active brain metastases (symptomatic and/or requiring corticosteroids) or leptomeningeal metastases
- Previous treatment with anticancer immunotherapy
- Pregnant or nursing (lactating) women
- Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
- Active autoimmune disease
- Immune deficiency or treatment with systemic corticosteroids
- Use of other investigational drugs (drugs not marketed for any indication) within 28 days before study drug administration
- Life expectancy of less than 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pembrolizumab and Entinostat
|
200 mg administered intravenously (IV) every third week until progression or unacceptable toxicity for a maximum of 24 months
5 mg by mouth (PO) once weekly until progression or unacceptable toxicity for a maximum of 24 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: From first dose up to 24 months
|
The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1.
|
From first dose up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical benefit rate (CBR)
Time Frame: 18 weeks from first dose
|
18 weeks from first dose
|
|
Progression free survival (PFS)
Time Frame: From first dose up to 24 months
|
From first dose up to 24 months
|
|
Overall Survival (OS)
Time Frame: From first dose up to 24 months
|
From first dose up to 24 months
|
|
Best overall response (BOR)
Time Frame: From first dose up to 24 months
|
From first dose up to 24 months
|
|
Time To Response (TTR)
Time Frame: From first dose up to 24 months
|
From first dose up to 24 months
|
|
Duration of objective response (DOR)
Time Frame: From first dose up to 24 months
|
From first dose up to 24 months
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time Frame: From first dose up to 24 months
|
Incidence and severity
|
From first dose up to 24 months
|
Eastern Cooperative Oncology Group (ECOG) Performance status (PS)
Time Frame: 18 weeks from first dose
|
18 weeks from first dose
|
|
Quality of Life (QoL) assessed by FACT-G
Time Frame: From first dose up to 24 months
|
From first dose up to 24 months
|
|
Quality of Life (QoL) assessed by EQ5D-3L
Time Frame: From first dose up to 24 months
|
From first dose up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ny L, Jespersen H, Karlsson J, Alsen S, Filges S, All-Eriksson C, Andersson B, Carneiro A, Helgadottir H, Levin M, Ljuslinder I, Olofsson Bagge R, Sah VR, Stierner U, Stahlberg A, Ullenhag G, Nilsson LM, Nilsson JA. The PEMDAC phase 2 study of pembrolizumab and entinostat in patients with metastatic uveal melanoma. Nat Commun. 2021 Aug 27;12(1):5155. doi: 10.1038/s41467-021-25332-w.
- Sah VR, Jespersen H, Karlsson J, Nilsson LM, Bergqvist M, Johansson I, Carneiro A, Helgadottir H, Levin M, Ullenhag G, Stahlberg A, Olofsson Bagge R, Nilsson JA, Ny L. Chemokine Analysis in Patients with Metastatic Uveal Melanoma Suggests a Role for CCL21 Signaling in Combined Epigenetic Therapy and Checkpoint Immunotherapy. Cancer Res Commun. 2023 May 18;3(5):884-895. doi: 10.1158/2767-9764.CRC-22-0490. eCollection 2023 May.
- Jespersen H, Olofsson Bagge R, Ullenhag G, Carneiro A, Helgadottir H, Ljuslinder I, Levin M, All-Eriksson C, Andersson B, Stierner U, Nilsson LM, Nilsson JA, Ny L. Concomitant use of pembrolizumab and entinostat in adult patients with metastatic uveal melanoma (PEMDAC study): protocol for a multicenter phase II open label study. BMC Cancer. 2019 May 2;19(1):415. doi: 10.1186/s12885-019-5623-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2018
Primary Completion (Actual)
January 31, 2023
Study Completion (Actual)
January 31, 2023
Study Registration Dates
First Submitted
February 22, 2016
First Submitted That Met QC Criteria
February 26, 2016
First Posted (Estimated)
March 3, 2016
Study Record Updates
Last Update Posted (Actual)
December 8, 2023
Last Update Submitted That Met QC Criteria
December 1, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Eye Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Uveal Diseases
- Neuroendocrine Tumors
- Nevi and Melanomas
- Eye Neoplasms
- Melanoma
- Uveal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Histone Deacetylase Inhibitors
- Pembrolizumab
- Entinostat
Other Study ID Numbers
- 2016-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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