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Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye (PEMDAC)

Primary Purpose

Metastatic Uveal Melanoma

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Pembrolizumab
Entinostat
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Uveal Melanoma focused on measuring Uveal melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of oncology, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pembrolizumab and Entinostat

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1.

Secondary Outcome Measures

Clinical benefit rate (CBR)
Progression free survival (PFS)
Overall Survival (OS)
Best overall response (BOR)
Time To Response (TTR)
Duration of objective response (DOR)
Adverse Events (AEs) and Serious Adverse Events (SAEs).
Incidence and severity
Eastern Cooperative Oncology Group (ECOG) Performance status (PS)
Quality of Life (QoL) assessed by FACT-G
Quality of Life (QoL) assessed by EQ5D-3L

Full Information

First Posted
February 22, 2016
Last Updated
October 15, 2019
Sponsor
Vastra Gotaland Region
Collaborators
Merck Sharp & Dohme LLC, Syndax Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02697630
Brief Title
Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye
Acronym
PEMDAC
Official Title
A Multicenter Phase II Open Label Study to Evaluate Efficacy of Concomitant Use of Pembrolizumab and Entinostat in Adult Patients With Metastatic Uveal Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Merck Sharp & Dohme LLC, Syndax Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Uveal Melanoma
Keywords
Uveal melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab and Entinostat
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
200 mg administered intravenously (IV) every third week until progression or unacceptable toxicity for a maximum of 24 months
Intervention Type
Drug
Intervention Name(s)
Entinostat
Intervention Description
5 mg by mouth (PO) once weekly until progression or unacceptable toxicity for a maximum of 24 months
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1.
Time Frame
From first dose up to 24 months
Secondary Outcome Measure Information:
Title
Clinical benefit rate (CBR)
Time Frame
18 weeks from first dose
Title
Progression free survival (PFS)
Time Frame
From first dose up to 24 months
Title
Overall Survival (OS)
Time Frame
From first dose up to 24 months
Title
Best overall response (BOR)
Time Frame
From first dose up to 24 months
Title
Time To Response (TTR)
Time Frame
From first dose up to 24 months
Title
Duration of objective response (DOR)
Time Frame
From first dose up to 24 months
Title
Adverse Events (AEs) and Serious Adverse Events (SAEs).
Description
Incidence and severity
Time Frame
From first dose up to 24 months
Title
Eastern Cooperative Oncology Group (ECOG) Performance status (PS)
Time Frame
18 weeks from first dose
Title
Quality of Life (QoL) assessed by FACT-G
Time Frame
From first dose up to 24 months
Title
Quality of Life (QoL) assessed by EQ5D-3L
Time Frame
From first dose up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of oncology, Sahlgrenska University Hospital
City
Gothenburg
State/Province
Västra Götaland Region
ZIP/Postal Code
SE-413 45
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34453044
Citation
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.
Results Reference
derived
PubMed Identifier
31046743
Citation
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.
Results Reference
derived

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Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye

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