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Also known as melphalan
Hepzato Kit (melphalan HDS) · 5 trials · 9 indications
The number and type of adverse events will be assessed per CTCAE version 5.0.
Objective Response Rate (partial or complete) as determined by Independent Central Review Committee. This is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Hepatic Progression Free Survival
| Arm | Type | Description |
|---|---|---|
| Melphalan/HDS | EXPERIMENTAL | Eligible patients will be treated with Melphalan/HDS 3.0 mg/kg Ideal Body Weight (IBW). Melphalan/HDS treatment will be administered every 6 weeks for a total of 6 cycles with an acceptable delay of another 2 weeks before the next planned treatment to allow for recovery of melphalan-related toxicity, if needed. |
| Arm I | EXPERIMENTAL | Patients undergo an isolated hepatic arterial infusion of melphalan over 30 minutes on day 1. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response undergo 2 additional courses in the absence of ongoing or increasing toxicity. |
| Arm II | ACTIVE_COMPARATOR | Patients receive the best alternative therapy comprising supportive care, systemic or regional chemotherapy, hepatic artery (chemo)-embolization, or any other appropriate therapy at the National Cancer Institute or therapy at the discretion of their physician. Patients may cross over to arm I if they have evidence of disease progression. |
| Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) | EXPERIMENTAL | Melphalan/HDS is given as an infusion of Melphalan into the hepatic artery under general anesthesia. This treatment is administered then followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) then repeated for a second cycle of Melphanlan/HDS followed by Physician's choice of SOC. |
| Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) Alone | ACTIVE_COMPARATOR | Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) |
| Melphalan/HDS followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab | EXPERIMENTAL | Melphalan/HDS is given as an infusion of Melphalan into the hepatic artery under general anesthesia. This treatment is administered twice, 8 weeks apart. Following 2 treatments with Melphalan/HDS, Trifluridine-tipiracil is given 35 mg/m2 up to a maximum of 80 mg per dose orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle; and intravenous (IV) bevacizumab 5 mg/kg body weight on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity |
| Trifluridine-tipiracil plus Bevacizumab Alone | ACTIVE_COMPARATOR | Trifluridine-tipiracil plus Bevacizumab is the standard of care for patients with metastatic colorectal cancer. Trifluridine-tipiracil is given 35 mg/m2 up to a maximum of 80 mg per dose orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle; and intravenous (IV) bevacizumab 5 mg/kg body weight on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity |
| Name | Type | Description |
|---|---|---|
| Melphalan (3 mg/kg IBW) with Hepatic Delivery System (HDS) | COMBINATION_PRODUCT | Melphalan administered directly to the liver via the Hepatic Delivery System (HDS) infused over a 30 minute period, followed by a 30 minute washout period |
| Melphalan/HDS | COMBINATION_PRODUCT | Melphalan (3 mg/kg IBW) with Hepatic Device System (HDS) |
| melphalan | DRUG | Given throug isolated hepatic artery infusion |
| regional chemotherapy | DRUG | Patients receive the best alternative therapy |
| systemic chemotherapy | DRUG | Patients receive the best alternative therapy |
| hepatic artery embolization | PROCEDURE | Patients receive the best alternative therapy |
| Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) | DRUG | Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) |
| Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) | DRUG | Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) |
| Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab | DRUG | Trifluridine-tipiracil plus Bevacizumab Alone |
| Trifluridine-tipiracil plus Bevacizumab Alone | DRUG | Trifluridine-tipiracil plus Bevacizumab Alone |
Inclusion Criteria: 1. Male or female patients ≥ 18 years of age. 2. Patients must weigh ≥ 35 kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System). 3. 50% or less histologically or cytologically-p...
Hepzato Kit (melphalan HDS) is studied for cancers that are dominant in the liver, including metastatic ocular melanoma, metastatic breast cancer in the liver, and refractory metastatic colorectal cancer. It delivers high-dose melphalan directly into the liver through a hepatic delivery system. It is being developed by Delcath Systems, Inc. (DCTH).
Hepzato Kit (melphalan HDS) is developed by Delcath Systems, Inc., which trades on Nasdaq under the ticker DCTH. The company is studying the melphalan hepatic delivery system across several liver-dominant cancer indications, including metastatic ocular melanoma, metastatic breast cancer in the liver, and refractory metastatic colorectal cancer.
Hepzato Kit (melphalan HDS) has been evaluated in Phase 3 studies, including a completed 102-patient Phase 3 trial in hepatic-dominant ocular melanoma. Additional Phase 2 trials in metastatic breast cancer and refractory metastatic colorectal cancer with liver-dominant disease are currently recruiting. The program remains in clinical development across these indications.
Hepzato Kit (melphalan HDS) is being studied in NCT06875128, a recruiting Phase 2 trial in metastatic breast cancer with liver-dominant disease, and NCT06607458, a recruiting Phase 2 trial in refractory metastatic colorectal cancer with liver-dominant disease. The completed Phase 3 trial NCT02678572 enrolled 102 patients with hepatic-dominant ocular melanoma, and NCT05022901 is an active expanded access study in the same indication.
Yes. Hepzato Kit is the product name for melphalan delivered with the Hepatic Delivery System, also written as melphalan HDS or Melphalan/HDS. The names refer to the same high-dose melphalan therapy given directly into the liver. Related trial descriptions also refer to Melphalan/HDS followed by consolidation treatment or by physician's choice of standard of care.
The Hepzato Kit (melphalan HDS) trials enroll patients across the United States and Europe. The metastatic breast cancer trial operates in the United States, Italy, Sweden, and the United Kingdom. The colorectal cancer trial runs in the United States, Czechia, Germany, Italy, the Netherlands, Serbia, Spain, Turkey, and the United Kingdom. The completed Phase 3 ocular melanoma trial spanned the United States and seven European countries.