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

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ClinicalTrials.gov Identifier: NCT02697630
Recruitment Status : Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : January 28, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Syndax Pharmaceuticals
Information provided by (Responsible Party):
Vastra Gotaland Region

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.

Condition or disease Intervention/treatment Phase
Metastatic Uveal Melanoma Drug: Pembrolizumab Drug: Entinostat Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2023


Arm Intervention/treatment
Experimental: Pembrolizumab and Entinostat Drug: Pembrolizumab
200 mg administered intravenously (IV) every third week until progression or unacceptable toxicity for a maximum of 24 months

Drug: Entinostat
5 mg by mouth (PO) once weekly until progression or unacceptable toxicity for a maximum of 24 months




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical benefit rate (CBR) [ Time Frame: 18 weeks from first dose ]
  2. Progression free survival (PFS) [ Time Frame: From first dose up to 24 months ]
  3. Overall Survival (OS) [ Time Frame: From first dose up to 24 months ]
  4. Best overall response (BOR) [ Time Frame: From first dose up to 24 months ]
  5. Time To Response (TTR) [ Time Frame: From first dose up to 24 months ]
  6. Duration of objective response (DOR) [ Time Frame: From first dose up to 24 months ]
  7. Adverse Events (AEs) and Serious Adverse Events (SAEs). [ Time Frame: From first dose up to 24 months ]
    Incidence and severity

  8. Eastern Cooperative Oncology Group (ECOG) Performance status (PS) [ Time Frame: 18 weeks from first dose ]
  9. Quality of Life (QoL) assessed by FACT-G [ Time Frame: From first dose up to 24 months ]
  10. Quality of Life (QoL) assessed by EQ5D-3L [ Time Frame: From first dose up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697630


Locations
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Sweden
Department of oncology, Sahlgrenska University Hospital
Gothenburg, Västra Götaland Region, Sweden, SE-413 45
Sponsors and Collaborators
Vastra Gotaland Region
Merck Sharp & Dohme Corp.
Syndax Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02697630     History of Changes
Other Study ID Numbers: 2016-1
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vastra Gotaland Region:
Uveal melanoma

Additional relevant MeSH terms:
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Entinostat
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action