Not recruitingRare disease

Study on Nemvaleukin Alfa and Pembrolizumab for Patients with Advanced Skin or Mucosal Melanoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two types of skin cancer: advanced cutaneous melanoma and advanced mucosal melanoma. The study is testing a treatment called nemvaleukin alfa, also known by its code name ALKS 4230. This treatment is being used alone and in combination with another medication called pembrolizumab, which is also known as Keytruda. The purpose of the study is to evaluate how well these treatments work in fighting the cancer.

Participants in the study will receive the treatments through an injection into a vein, which is known as intravenous use. The study will observe how the cancer responds to the treatment over time. Some participants will receive nemvaleukin alfa by itself, while others will receive it together with pembrolizumab. The study aims to see if these treatments can help reduce the size of the cancer or stop it from growing.

The study will take place over a period of time, during which participants will have regular visits to monitor their health and the effects of the treatment. The study will also look at the safety of the treatments and any side effects that may occur. The goal is to gather information that could help improve treatment options for people with these types of melanoma in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be assigned to one of the four cohorts based on their specific type of melanoma and previous treatments. The patient will be informed about the cohort they belong to and the treatment plan associated with it.
Step 2
Treatment administration
The patient will receive treatment with nemvaleukin alfa and/or pembrolizumab through an intravenous (IV) infusion. The specific medication and combination depend on the cohort assignment.
For patients in Cohort 1, treatment involves nemvaleukin alfa as a monotherapy. In Cohort 2, nemvaleukin alfa is also administered as a monotherapy. Cohort 3 involves less frequent IV dosing of nemvaleukin alfa. Cohort 4 includes a combination of nemvaleukin alfa and pembrolizumab.
Step 3
Treatment schedule
The treatment schedule will vary depending on the cohort. The patient will be informed about the frequency and duration of the treatment sessions. The healthcare team will provide detailed instructions on when to attend the clinic for each infusion.
Step 4
Monitoring and assessments
Throughout the trial, the patient will undergo regular monitoring and assessments to evaluate the response to the treatment. This includes physical examinations, blood tests, and imaging studies to track the progress of the melanoma.
The patient will be required to attend scheduled visits to the clinic for these assessments. The healthcare team will provide guidance on the specific tests and procedures involved.
Step 5
Safety and side effects
The safety and tolerability of the treatment will be closely monitored. The patient will be informed about potential side effects and will be asked to report any adverse reactions experienced during the trial.
Regular checks of vital signs, weight, and other clinical parameters will be conducted to ensure the patient's well-being.
Step 6
Completion of the trial
Upon completion of the treatment period, the patient will undergo a final assessment to evaluate the overall response to the therapy. The healthcare team will discuss the results and any further steps that may be necessary.
The patient will receive information on follow-up care and any additional support required after the trial concludes.

Who can join the trial?

14 criteria

Patient is 18 years of age or older.
Patient or patient's legal representative is willing and able to provide written informed consent (agreement to participate after understanding the study).
Patient is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
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Patient must have one of the following conditions:
- Cohort 1: Unresectable and/or metastatic cutaneous melanoma. No more than 5 patients with acral melanoma may enroll.
- Cohort 2: Unresectable and/or metastatic mucosal melanoma.
- Cohort 3: Unresectable and/or metastatic cutaneous melanoma. No patients with mucosal or acral melanoma may enroll.
- Cohort 4: Unresectable and/or metastatic cutaneous melanoma. No patients with mucosal or acral melanoma may enroll.
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  Patients who have received the following prior therapies:
  - Cohorts 1 and 2: Patients who have received anti-PD-[L]1 therapy with or without anti-CTLA-4 therapy, and one or fewer other prior systemic anti-cancer treatments. Patients must have shown a response or stable disease to anti-PD-[L]1 therapy. Patients with confirmed disease progression may be included if they received anti-PD-[L]1 therapy for at least 12 weeks. Patients with BRAF mutations may or may not have received prior targeted therapy.
  - Cohort 3: Patients who have received anti-PD-[L]1 therapy with or without anti-CTLA-4 or anti-LAG-3 therapy, and one or fewer other prior systemic anti-cancer treatments. Patients must have shown a response or stable disease to anti-PD-[L]1 therapy. Patients with confirmed disease progression may be included if they received anti-PD-[L]1 therapy for at least 12 weeks. Patients with BRAF mutations may or may not have received prior targeted therapy.
  - Cohort 4: Patients must not have received prior systemic anti-cancer therapy for unresectable or metastatic melanoma. Prior adjuvant or neoadjuvant PD-[L]1 treatments are allowed if there is at least 6 months between the last dose and date of recurrence.
  - Cohorts 1, 2, and 3: Patients who have received prior treatment with talimogene laherparepvec (TVEC) are allowed if the last exposure was at least 28 days before the first exposure to nemvaleukin and all injection-site reactions have resolved.
  - Patient has at least one measurable lesion (a tumor that can be measured) that qualifies as a target lesion based on RECIST 1.1 criteria. Tumor lesions in previously treated areas are not considered measurable unless they have shown progression.
  - Cohort 1 and Cohort 2 (required); Cohort 3 (optional but recommended if lesions are accessible) and Cohort 4 (may be required for certain conditions, otherwise optional but recommended if lesions are accessible): Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying archival tumor tissue. Archival tissue must have been sampled after the last exposure to any systemic anti-cancer agent. Patients in Cohort 1 and Cohort 2 who cannot undergo a biopsy may be enrolled if the risk/benefit ratio is unfavorable or if a biopsy would cause significant delays in care, with supporting documentation from the Investigator.
  - Patient has recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anti-cancer therapy, radiotherapy, and/or surgery. Residual side effects should be no worse than Grade 1, except for Grade 2 treatment-associated peripheral neuropathy or any grade of hair loss, which are acceptable if all other criteria are met.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer that is not advanced cutaneous melanoma or advanced mucosal melanoma cannot participate.
Patients who have had another cancer in the past, unless it was a type that is not expected to come back, cannot participate.
Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals cannot participate.
Patients who have a history of severe allergic reactions to similar drugs cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have an autoimmune disease, which is when the body's immune system attacks its own cells, cannot participate.
Patients who have received another investigational drug within the last 4 weeks cannot participate.
Patients who have a serious heart condition cannot participate.
Patients who have uncontrolled high blood pressure cannot participate.
Patients who have a history of drug or alcohol abuse within the last year cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Verified
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy
Responsive
Istituto Oncologico Veneto
Padua, Italy

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Investigated drugs

Nemvaleukin Alfa (ALKS 4230)
is a medication being studied for its potential to help the body's immune system fight cancer. It is designed to activate certain immune cells that can attack and destroy cancer cells. In this trial, Nemvaleukin Alfa is being tested both on its own and in combination with another medication to see how well it works in treating advanced forms of skin and mucosal melanoma, which are types of cancer.
Pembrolizumab
is a medication that helps the immune system recognize and attack cancer cells. It works by blocking a specific protein that prevents the immune system from attacking the cancer. In this trial, Pembrolizumab is used in combination with Nemvaleukin Alfa to see if the two medications together can improve the treatment of advanced melanoma compared to using Nemvaleukin Alfa alone.

What is already known about the treatment

Nemvaleukin Alfa (ALKS 4230) – Nemvaleukin Alfa is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating advanced cutaneous and mucosal melanoma. It is being tested both as a standalone treatment and in combination with another medication called Pembrolizumab. The main goal of this study is to see how well Nemvaleukin Alfa can help reduce tumor size in patients. At the molecular level, Nemvaleukin Alfa works by stimulating the immune system to attack cancer cells more effectively. It is classified as an immunotherapy drug, which means it helps the body's natural defenses fight cancer.

Investigated diseases

Advanced Cutaneous Melanoma
This is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. As the disease progresses, it can spread to other parts of the body, including lymph nodes and internal organs. The progression is often marked by changes in the size, shape, or color of existing moles or the appearance of new pigmented or unusual-looking growths on the skin. Advanced stages may involve deeper layers of the skin and other tissues. The disease can become more aggressive and difficult to manage as it advances.
Advanced Mucosal Melanoma
This is a rare form of melanoma that occurs in the mucous membranes of the body, such as those lining the nasal passages, mouth, and other areas. It progresses by invading surrounding tissues and can spread to distant parts of the body. The disease often presents with non-specific symptoms, which can lead to delays in diagnosis. As it advances, it may cause symptoms related to the affected mucosal site, such as bleeding or obstruction. The progression can be rapid, with a tendency to metastasize to other organs.