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CompletedNCT02697630PEMDACUpdated Dec 8, 2023

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

A Phase 2 interventional study of Pembrolizumab and Entinostat in Metastatic Uveal Melanoma, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by Vastra Gotaland Region · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Metastatic Uveal Melanoma

Keywords

  • Uveal melanoma
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In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 29 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Pembrolizumab and Entinostat

    Drug: Pembrolizumab · Drug: Entinostat

Interventions

  • DrugPembrolizumab

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

  • DrugEntinostat

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: From first dose up to 24 months

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).

    Incidence and severity

    Time frame: From first dose up to 24 months

  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

07

Study locations

1 site
  • Department of oncology, Sahlgrenska University Hospital
    Gothenburg, Västra Götaland Region SE-413 45, Sweden
08

References and documents

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. PubMed 34453044 ↗
  • 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. PubMed 37377898 ↗
  • 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. PubMed 31046743 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02697630
Lead sponsor
Vastra Gotaland Region
Collaborators
Merck Sharp & Dohme LLC, Syndax Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 3, 2016
Start date
Feb 21, 2018
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023
Last update
Dec 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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