Metastatic Uveal Melanoma
Conditions
Keywords
Uveal melanoma
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.
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
Sponsors
Merck Sharp & Dohme LLC
Syndax Pharmaceuticals
Vastra Gotaland Region
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Time To Response (TTR) | From first dose up to 24 months | — |
| Clinical benefit rate (CBR) | 18 weeks from first dose | — |
| 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 FACT-G | From first dose up to 24 months | — |
| Quality of Life (QoL) assessed by EQ5D-3L | From first dose up to 24 months | — |
| Duration of objective response (DOR) | From first dose up to 24 months | — |
Countries
Sweden
Outcome results
None listed