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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Institut Gustave Roussy	Villejuif	France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Hospital General Universitario De Valencia	Valencia	Spain
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Vrije Universiteit Brussel	Jette	Belgium
Centre Hospitalier Universitaire De Nantes	Nantes	France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Vall D Hebron Institute Of Oncology	Barcelona	Spain
Axzctjj Oafosilzujx Ucgzkznwmszcx Sxemlj	Siena	Italy
Huhlseqd Uapakdmqxankn Dnrgjirk	Donostia / San Sebastian	Spain
Kfwkrmor dyz Uiuotwxieiwq Mugbomme Aqb	Munich	Germany
Cdcyjt Lhro Blktcc	Lyon	France
Idstktpl Rzldnpzmy Pjm Lx Shzcan Dkg Tgivgi Doew Atnctoo Imiu Shlrda	Meldola	Italy
Amvsoqlnrd Plyruqam Hdcgqytt Dp Pxcfd	Paris	France
Udpslxuhvxktxszsmknmm Wsutxwnee Afq	Wuerzburg	Germany
Uxddlrdehh Mrxdyzl Czgmfo Hahsapdppsnesetbk	Hamburg	Germany
Ubwuykaeirizghxqztzxg Ebyeo Aft	Essen	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.10.2022
France	Not recruiting	01.10.2022
Germany	Not recruiting	01.10.2022
Italy	Not recruiting	01.10.2022
Spain	Not recruiting	01.10.2022

Trial locations

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.

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.

Trial ID:

2022-500652-37-00

Protocol code:

C-800-23

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?