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

Phase 2

Completed

• Conditions: Metastatic Uveal Melanoma
• Interventions: Drug: Pembrolizumab; Drug: Entinostat

• Registration Number: NCT02697630
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-03-03
• Study Start: 2018-02-21
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pembrolizumab and Entinostat	Pembrolizumab	-
Pembrolizumab and Entinostat	Entinostat	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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

Name	Time	Method
Clinical benefit rate (CBR)	18 weeks from first dose
Duration of objective response (DOR)	From first dose up to 24 months
Quality of Life (QoL) assessed by FACT-G	From first dose up to 24 months
Time To Response (TTR)	From first dose up to 24 months
Adverse Events (AEs) and Serious Adverse Events (SAEs).	From first dose up to 24 months	Incidence and severity
Eastern Cooperative Oncology Group (ECOG) Performance status (PS)	18 weeks from first dose
Quality of Life (QoL) assessed by EQ5D-3L	From first dose up to 24 months
Progression free survival (PFS)	From first dose up to 24 months
Overall Survival (OS)	From first dose up to 24 months
Best overall response (BOR)	From first dose up to 24 months

Trial Locations

Locations (1)

Department of oncology, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götaland Region, Sweden