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NCT Number: NCT02697630

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

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.

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Key information

Conditions

Metastatic Uveal Melanoma Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Uveal Diseases Uveal Melanoma Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of oncology, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, SE-413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pembrolizumab

Drug

200 mg administered intravenously (IV) every third week until progression or unacceptable toxicity for a maximum of 24 months

Entinostat

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Merck Sharp & Dohme LLC
  • Syndax Pharmaceuticals

Registry information

Official study 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

Acronym: PEMDAC

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2016
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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