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

NCT ID: NCT02697630

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-21

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Uveal Melanoma

Keywords

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Uveal melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pembrolizumab and Entinostat

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type DRUG

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

Entinostat

Intervention Type DRUG

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

Interventions

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Pembrolizumab

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

Intervention Type DRUG

Entinostat

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Syndax Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of oncology, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 34453044 (View on PubMed)

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.

Reference Type RESULT
PMID: 37377898 (View on PubMed)

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.

Reference Type RESULT
PMID: 31046743 (View on PubMed)

Other Identifiers

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2016-1

Identifier Type: -

Identifier Source: org_study_id