Clinical Trials Search
Clinical Trial 18569
Cancer Type:
Interventions:Alkeran (Melphalan); DTIC (Dacarbazine); Dacarbazine; Ipilimumab; Melphalan; Pembrolizumab (Keytruda); Yervoy (Ipilimumab)
Study Type: Treatment
Phase of Study: Phase III
Investigators:
- Jonathan Zager
Study Title
A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma
Summary
The purpose of this study is to study the effectiveness of melphalan treatment.
Objective
Objectives: Primary Objective: To compare overall survival (OS) in patients with hepatic-dominant metastatic ocular melanoma treated with Melphalan/HDS versus best alternative care (BAC). Secondary Objectives: To compare the overall progression-free survival (PFS) (as determined by the Investigator) of patients with hepatic-dominant metastatic ocular melanoma treated with Melphalan/HDS versus control (BAC). To compare the objective response rate (ORR = complete + partial response) (as determined by the Investigator) of treatment with Melphalan/HDS versus control (BAC) in patients with hepatic-dominant metastatic ocular melanoma. Exploratory Objectives: To compare the PFS (as determined by Independent Central Review) of patients with hepatic-dominant metastatic ocular melanoma treated with Melphalan/HDS versus control (BAC). To compare the ORR (as determined by Independent Central Review) of treatment with Melphalan/HDS versus control (BAC) in patients with hepatic-dominant metastatic ocular melanoma. To compare the hepatic progression-free survival (hPFS) (as determined by Independent Central Review) of patients with hepatic-dominant metastatic ocular melanoma treated with Melphalan/HDS versus control (BAC). To compare the hepatic objective response rate (hORR) (as determined by Independent Central Review) of treatment with Melphalan/HDS versus control (BAC) in patients with hepatic-dominant metastatic ocular melanoma. To compare the quality of life (QOL) in patients with hepatic-dominant metastatic ocular melanoma treated with Melphalan/HDS versus control (BAC). To evaluate the safety of treatment with Melphalan/HDS in patients with hepatic-dominant metastatic ocular melanoma. To explore relationships between melphalan exposure and common or serious adverse reactions and clinical outcomes. To characterize the local and systemic exposure of Melphalan administered by the HDS.