Not recruiting

Study of BI-1607, Ipilimumab, and Pembrolizumab for Patients with Advanced Melanoma

Verified siteRegistered drugNo 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 called unresectable or metastatic melanoma. This means the cancer cannot be removed by surgery or has spread to other parts of the body. The study will test a new treatment combination involving three medications: BI-1607, Ipilimumab (also known as YERVOY), and Pembrolizumab (also known as KEYTRUDA). These medications are given through an intravenous injection, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to find the best doses of these medications when used together and to see how well they work in treating melanoma. The study will also look at how safe the treatment is and how well patients can tolerate it. Participants will receive the treatment and be monitored for any side effects or changes in their health. The study will be conducted in two phases: Phase 1b will focus on determining the recommended doses, and Phase 2a will assess the treatment's effectiveness in shrinking the cancer.

Throughout the study, participants will have regular check-ups to monitor their health and the progress of the treatment. This includes tracking any side effects and measuring how the cancer responds to the treatment. The study aims to provide valuable information on the potential benefits and risks of using BI-1607 in combination with Ipilimumab and Pembrolizumab for treating unresectable or metastatic melanoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A biopsy of the tumor is required unless a recent sample is available. This biopsy must be from a non-irradiated area and taken at least four weeks after the last cancer treatment.
Step 2
Treatment phase 1b
The first phase involves determining the appropriate doses of the medications. The medications used are pembrolizumab, ipilimumab, and BI-1607, all administered through intravenous injection.
The focus is on assessing the safety and tolerability of the combination of these medications.
Step 3
Treatment phase 2a
In this phase, the effectiveness of the treatment is evaluated. The goal is to observe the anti-tumor activity of the medication combination.
Regular monitoring of tumor response and progression is conducted using imaging and other diagnostic tools.
Step 4
Monitoring and follow-up
Throughout the trial, regular assessments are performed to monitor health status, including vital signs, laboratory tests, and electrocardiograms.
The occurrence of any side effects or adverse events is closely monitored and documented.
Step 5
Completion and evaluation
Upon completion of the trial, a final evaluation is conducted to assess the overall response to the treatment.
Participants may be required to continue follow-up visits to monitor long-term effects and overall survival.

Who can join the trial?

11 criteria

The patient must be willing and able to provide written permission to participate in the trial.
The patient must be at least 18 years old on the day they sign the consent form.
The patient must have a confirmed diagnosis of advanced melanoma that cannot be removed by surgery or has spread to other parts of the body, with proof that the disease is getting worse.
The patient must have previously been treated with a type of medicine called anti-PD-1/L1 mAb and shown disease progression. For patients with a specific type of melanoma called uveal melanoma, previous treatment with anti-PD-1/L1 is not required.
The patient must have at least one area of the disease that can be measured using specific criteria called RECIST v1.1.
The patient must be willing to provide samples of their tumor tissue for testing, unless there is a medical or safety reason not to. This includes a sample taken before the first dose of the trial medication, and it must be from an area not previously treated with radiation. If a new sample cannot be taken, a recent sample from a previous biopsy may be used.
The patient must have a life expectancy of at least 12 weeks.
The patient must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well they can perform daily activities.
The patient must have normal organ function as shown by lab tests.
If the patient has hepatitis B, they can participate if they have been on antiviral treatment for at least 4 weeks and have no detectable virus in their blood. They must continue treatment during the trial and follow local guidelines after the trial.
If the patient has had hepatitis C, they can participate if there is no detectable virus in their blood at the start of the trial. They must have completed treatment to cure the infection at least 4 weeks before joining the trial.

Who cannot join the trial?

7 criteria

Patients who have a different type of cancer than the one being studied, which is called unresectable or metastatic melanoma. This means the cancer cannot be removed by surgery or has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not able to safely receive the study medications due to other health conditions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have certain medical conditions that might interfere with the study.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

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

Charite Research Organisation GmbH
Verified
Berlin, Germany
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

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Investigated drugs

BI-1607
is an experimental medication being studied for its potential to help the immune system fight cancer. It is a type of monoclonal antibody that targets a specific protein on immune cells, which may enhance the body's ability to attack cancer cells. In this trial, it is being tested in combination with other cancer treatments to see if it can improve their effectiveness.
Ipilimumab
is a medication used to treat certain types of cancer by helping the immune system recognize and destroy cancer cells. It works by blocking a protein that normally keeps immune cells from attacking the body’s own tissues, thereby boosting the immune response against cancer cells.
Pembrolizumab
is another cancer treatment that helps the immune system fight cancer. It works by blocking a protein on cancer cells that helps them hide from the immune system. By blocking this protein, pembrolizumab allows immune cells to better detect and attack cancer cells.

What is already known about the treatment

BI-1607
This medication is administered as an injection and is currently being studied in clinical trials for its potential use in treating unresectable or metastatic melanoma. It is an Fc-engineered monoclonal antibody targeting FcγRIIB (CD32b), which is designed to enhance the immune system's ability to fight cancer cells. BI-1607 is classified as an immunotherapy agent and is being evaluated for its safety, tolerability, and effectiveness in combination with other immunotherapies like ipilimumab and pembrolizumab.
Ipilimumab
Administered via injection, ipilimumab is an established medication used in the treatment of certain types of cancer, including melanoma. It works by blocking CTLA-4, a protein receptor that downregulates the immune system, thereby enhancing the body's immune response against cancer cells. Ipilimumab is classified as a checkpoint inhibitor and is being studied in combination with BI-1607 and pembrolizumab to assess its effectiveness and safety in treating unresectable or metastatic melanoma.
Pembrolizumab
This medication is given through injection and is widely used in the treatment of various cancers, including melanoma. Pembrolizumab functions by inhibiting the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. It is classified as a checkpoint inhibitor and is part of ongoing research to evaluate its combined use with BI-1607 and ipilimumab for enhanced therapeutic outcomes in patients with unresectable or metastatic melanoma.

Investigated diseases

Unresectable or Metastatic Melanoma – This is a type of skin cancer that has spread beyond the original site and cannot be removed through surgery. It often begins in the cells that produce melanin, the pigment responsible for skin color. As the disease progresses, it can spread to other parts of the body, including lymph nodes, lungs, liver, brain, and bones. The spread of melanoma to distant organs is referred to as metastasis. Symptoms may include 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. The progression of the disease can vary, with some cases advancing rapidly while others may progress more slowly.