Melphalan + Tebentafusp for Eye Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for eye cancer that has spread to the liver. It aims to determine if using melphalan, a chemotherapy drug, followed by tebentafusp, an immune therapy, can effectively treat uveal melanoma with liver involvement. Participants must have uveal melanoma that has spread to the liver and be HLA-A*02:01-positive, a specific genetic marker. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take other anti-cancer therapies or immunosuppressive medications. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Melphalan/HDS is being tested for treating eye cancer that has spread to the liver. Safety data suggests that patients have achieved better results compared to other treatments. However, like many treatments, side effects can occur, and safety remains under study.
For tebentafusp, studies have found that almost all patients experience some side effects. Most are mild, but some can be more serious. Despite this, tebentafusp has extended the lives of patients with metastatic uveal melanoma.
Overall, both treatments appear promising but carry risks. This trial phase indicates there is still much to learn about their safety. When considering joining a trial, it's important to weigh the potential benefits and risks.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Melphalan/HDS and Tebentafusp for eye cancer because it offers a unique two-pronged approach. Unlike traditional treatments that often focus on either surgical options or systemic therapies like chemotherapy, this combination starts with a localized treatment using Melphalan/HDS delivered directly to the liver, which is a common site for metastasis in eye cancer. Following this, Tebentafusp, an innovative therapy that engages the immune system to target cancer cells, is administered. This dual strategy not only aims to control the disease locally but also boosts the body's immune response against the cancer, potentially leading to more effective and sustained outcomes.
What evidence suggests that this trial's treatments could be effective for metastatic uveal melanoma?
Research has shown that using melphalan directly in the liver effectively treats metastatic uveal melanoma (mUM), particularly when the cancer has spread to the liver. Studies have found that 36.3% of patients respond well to this treatment, experiencing improved survival times—living without the cancer worsening for about 9 months and living overall for about 20 months. In this trial, participants will receive sequential treatment with melphalan/HDS followed by tebentafusp. Tebentafusp has significantly improved survival in mUM patients, especially those with the HLA-A*02:01 marker, helping them live longer compared to other treatments. This combination works by using melphalan to activate the immune system, making the cancer more responsive to tebentafusp.12678
Who Is on the Research Team?
Jonathan Zager, MD, FACS
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with metastatic uveal melanoma (a type of eye cancer) that has spread to the liver. Participants must have a specific genetic marker, HLA-A*02:01, and should not have received certain prior treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Percutaneous Hepatic Perfusion (PHP) with Melphalan/HDS
Participants undergo two PHP procedures with melphalan/HDS, spaced 6-8 weeks apart
Tebentafusp Treatment
Tebentafusp is initiated within 6 weeks after the second PHP and administered weekly for 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Melphalan/HDS
- Tebentafusp
Trial Overview
The study tests a two-step treatment for liver metastases from uveal melanoma. First, Melphalan/HDS via PHP targets the liver directly. Then Tebentafusp is used to help the immune system fight cancer cells.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will undergo two percutaneous hepatic perfusion (PHP) procedures with melphalan/HDS, spaced 6-8 weeks apart. Tebentafusp will be initiated within 6 weeks (+/- 2 weeks) after the second PHP and administered weekly for 1 year. Additional PHP procedures (up to 6 total) may be performed as standard of care if disease progression occurs while on tebentafusp.
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Delcath Systems Inc.
Industry Sponsor
Citations
Efficacy and Safety of the Melphalan/Hepatic Delivery ...
A recent review reported overall ORR, median progression-free survival (mPFS), and mOS of 9.2 %, 3.0 months, and 11.5 months, respectively, for ...
Moffitt-Led International Study Finds New Drug Delivery ...
Patients treated with the melphalan hepatic delivery system experienced significantly improved outcomes than those receiving alternative care.
An Open-Label Expanded Access Study of the Melphalan ...
An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma · Study Overview · Contacts ...
4.
gastroenterologyadvisor.com
gastroenterologyadvisor.com/news/melphalan-hepatic-delivery-system-beneficial-for-metastatic-uveal-melanoma/Melphalan/Hepatic Delivery System Beneficial for ...
For patients with unresectable metastatic uveal melanoma, the drug/device combination melphalan/hepatic delivery system is efficacious.
5.
massgeneralbrigham.org
massgeneralbrigham.org/en/about/newsroom/articles/liver-directed-therapy-treats-metastatic-uveal-melanomaLiver-Directed Therapy Offers Effective Treatment for Rare ...
Overall response rate of 36.3%, disease control rate of 73.6%, progression free survival of 9.0 months, and overall survival of 20 months. A ...
6.
ecancer.org
ecancer.org/en/news/26299-study-finds-new-drug-delivery-system-effective-against-rare-eye-cancerStudy finds new drug delivery system effective against rare ...
Patients treated with the melphalan hepatic delivery system experienced significantly improved outcomes than those receiving alternative care.
Percutaneous Hepatic Perfusion (PHP) with Melphalan in ...
This two-center study aimed to examine the safety, response to therapy, and survival of patients with hepatic-dominant metastatic uveal melanoma (UM) treated ...
HEPZATO™ KIT (melphalan for injection/Hepatic Delivery ...
The PHP arm showed a statistically significant advantage over BAC in ORR, DCR, and PFS in the treatment of hepatic metastases from ocular melanoma. These ...
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