Not recruiting

Study on Botensilimab and Balstilimab for Patients with Advanced Melanoma Resistant to Previous Treatments

Verified siteInvestigationalNo placebo

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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 a type of skin cancer known as advanced melanoma, which has not responded to previous treatments called checkpoint inhibitors. The study is testing a new treatment using two medications: botensilimab and balstilimab. Botensilimab, also known by its code name AGEN1181, is a human antibody designed to target a specific protein involved in the immune system. Balstilimab, with the code name AGEN2034, is another human antibody that works by targeting a different protein to help the immune system fight cancer cells.

The purpose of this study is to evaluate how effective botensilimab is when used alone and in combination with balstilimab. Participants in the study will receive these medications as a solution through an infusion, which means the medicine is given directly into the bloodstream. The study will monitor the participants over a period to see how their cancer responds to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

Throughout the study, researchers will observe the participants to determine the objective response rate, which measures how well the cancer shrinks or disappears after treatment. They will also look at progression-free survival, which is the length of time during and after treatment that the cancer does not get worse, and overall survival, which is the time from the start of the study until death from any cause. The study aims to provide valuable information on the potential benefits of these new treatments for patients with advanced melanoma.

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
Initial consent and screening
Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.
A series of screening tests will be conducted to ensure you meet the study's eligibility criteria. These tests may include blood tests, imaging scans, and a review of your medical history.
Step 2
Treatment assignment
You will be assigned to a treatment group. The study involves the use of botensilimab alone or in combination with balstilimab.
The treatment is administered as a solution for infusion, which means it is given directly into your bloodstream through an intravenous (IV) line.
Step 3
Treatment administration
The botensilimab and balstilimab infusions will be given at regular intervals. The exact schedule and dosage will be explained to you by the study team.
You will need to visit the clinic for each infusion session. The duration of each session will depend on the specific treatment plan.
Step 4
Regular monitoring
Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging scans to assess your response to the treatment.
You will be asked to report any side effects or changes in your health to the study team immediately.
Step 5
Follow-up assessments
After completing the treatment phase, follow-up assessments will be conducted to evaluate the long-term effects of the treatment.
These assessments may include additional scans and tests to monitor your condition.
Step 6
End of study
The study is expected to conclude by March 31, 2025. At the end of the study, you will have a final evaluation to summarize your health status and any outcomes from the treatment.
You will receive information about the study results and any further steps if necessary.

Who can join the trial?

19 criteria

Must have advanced melanoma that has not responded to previous treatment with a type of medicine called a checkpoint inhibitor.
For Cohort A: Must have been treated with anti-PD-L1 therapy (like pembrolizumab or nivolumab) for at least 6 weeks and shown disease progression on scans.
For Cohort A: Disease progression must have occurred during treatment or within 12 weeks after the last dose in a metastatic setting, or within 24 weeks in an adjuvant/neoadjuvant setting.
For Cohort A: No other cancer treatments between the last anti-PD-L1 therapy and the start of the study treatment, except for local treatments or specific therapies for BRAF mutations.
For Cohort B: Must have been treated with first-generation anti-CTLA-4 therapy (like ipilimumab) and anti-PD-L1 therapy for at least 6 weeks.
For Cohort B: Disease must have progressed on the most recent cancer treatment.
For Cohort B: No more than 3 previous treatments for BRAF mutation in a metastatic setting, and no more than 2 for BRAF wild type.
Must voluntarily agree to participate by signing a consent form.
Must be 18 years of age or older.
Must have a confirmed diagnosis of Stage III (unresectable) or Stage IV melanoma.
Must be willing and able to follow the study requirements.
Must have measurable disease according to specific criteria.
Must know their BRAF V600 mutation status or agree to testing during the screening period.
Must have a life expectancy of at least 3 months.
Must have an ECOG performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have adequate organ function based on specific laboratory tests.
Must provide a tumor tissue sample from a recent biopsy, or agree to a new biopsy if needed.
Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for a period after the last dose of study treatment.
Men with partners who can become pregnant must agree to use effective birth control during the study and for a period after the last dose of study treatment. If the partner is pregnant, a condom must be used.

Who cannot join the trial?

8 criteria

Patients who have not responded to previous treatments with a type of medicine called checkpoint inhibitors cannot participate. These are drugs that help the immune system recognize and attack cancer cells.
Patients with other serious health conditions that could interfere with the study treatment are not eligible.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial within the last 30 days are not allowed to join.
Patients with a history of severe allergic reactions to similar drugs are excluded.
Patients with active infections that require treatment are not eligible.
Patients with a history of certain autoimmune diseases, where the immune system attacks the body, cannot participate.
Patients who have received a live vaccine within 30 days before the start of the study are not eligible.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain

Trial locations

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Investigated drugs

Botensilimab
is a medication being studied for its potential to treat advanced melanoma, a type of skin cancer. It is being tested to see if it can help patients whose cancer has not responded to previous treatments known as checkpoint inhibitors. Botensilimab is designed to work by helping the immune system recognize and attack cancer cells more effectively.
Balstilimab
is another medication involved in this study. It is used in combination with Botensilimab to see if the two drugs together can improve treatment outcomes for patients with advanced melanoma. Balstilimab also works by targeting the immune system, aiming to enhance its ability to fight cancer cells.

What is already known about the treatment

Botensilimab – Botensilimab is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating advanced melanoma that has not responded to previous treatments. It is a promising new therapy in the field of cancer treatment, particularly for patients who have not benefited from existing checkpoint inhibitor therapies. Botensilimab works by targeting specific proteins on immune cells, helping the body's immune system to better recognize and attack cancer cells. It is classified as an immunotherapy agent, which means it helps boost the body's natural defenses to fight cancer.

Investigated diseases

Advanced Melanoma – Advanced melanoma is a type of skin cancer that has spread beyond the original site to other parts of the body. It 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 invade nearby tissues and organs, leading to the formation of tumors in distant sites such as the lungs, liver, or brain. The progression of advanced melanoma is characterized by the uncontrolled growth of cancerous cells, which can lead to the disruption of normal bodily functions. The disease may also cause symptoms such as changes in existing moles, the appearance of new pigmented or unusual-looking growths on the skin, and other systemic symptoms depending on the organs affected.