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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Syndax Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab and Entinostat | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | 200 mg administered intravenously (IV) every third week until progression or unacceptable toxicity for a maximum of 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first dose up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit rate (CBR) | 18 weeks from first dose | |
| Progression free survival (PFS) | From first dose up to 24 months | |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of oncology, Sahlgrenska University Hospital | Gothenburg | Västra Götaland County | SE-413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34453044 | Result | 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. | |
| 37377898 |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C118739 | entinostat |
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| Entinostat | Drug | 5 mg by mouth (PO) once weekly until progression or unacceptable toxicity for a maximum of 24 months |
|
| 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 |
| Duration of objective response (DOR) | From first dose up to 24 months |
| Adverse Events (AEs) and Serious Adverse Events (SAEs). | Incidence and severity | From first dose up to 24 months |
| 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 |
| Result |
| 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. |
| 31046743 | Result | 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. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |