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Study on LAVA-1207 and Pembrolizumab for Patients with Advanced Prostate Cancer Resistant to Treatment

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 cancer known as metastatic castration-resistant prostate cancer (mCRPC). This is a form of prostate cancer that continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The study is testing a new treatment called LAVA-1207, which is a special type of protein designed to help the body's immune system target and fight cancer cells. LAVA-1207 is being tested alone and in combination with other treatments, including a low dose of a substance called interleukin-2 and a medication known as Pembrolizumab, which is also referred to by its code name, MK-3475.

The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients whose prostate cancer has not responded to other therapies. The study will be conducted in two parts. In the first part, different doses of LAVA-1207, both alone and in combination with the other treatments, will be tested to find the most suitable dose. In the second part, the study will expand to include more patients to further assess the safety and potential benefits of the treatments. Throughout the study, participants will receive the treatments through an infusion, which is a method of delivering medication directly into the bloodstream.

Participants in the study will be closely monitored to observe how their cancer responds to the treatments and to identify any side effects. The study aims to provide valuable information about the potential of LAVA-1207 and its combinations as a treatment option for patients with advanced prostate cancer. This research could lead to new ways to manage and treat this challenging form of cancer.

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 informed about the trial's objectives and procedures. The patient must provide informed consent to participate.
Eligibility criteria include being a male patient with metastatic castration-resistant prostate cancer (mCRPC) and having previously undergone specific treatments.
Step 2
Initial Assessment
The patient will undergo a series of assessments to establish baseline health status. This includes imaging tests like CT or MRI scans and blood tests to measure PSA levels.
These assessments help determine the patient's current disease status and eligibility for specific treatment arms within the trial.
Step 3
Treatment Phase 1: Dose Escalation
The patient will receive LAVA-1207, either alone or in combination with low-dose interleukin-2 (LDSC IL-2) or pembrolizumab. The purpose is to find a safe and effective dose.
Pembrolizumab is administered as a concentrate for solution for infusion, typically at a dosage of 25 mg/mL.
Step 4
Monitoring and Adjustments
Throughout the treatment, the patient will be closely monitored for any side effects or adverse reactions. Adjustments to the treatment may be made based on these observations.
The frequency and severity of any adverse events will be recorded using standardized criteria.
Step 5
Treatment Phase 2: Expansion Cohort
Once a safe dose is established, the patient may continue treatment in the expansion cohort to further evaluate the treatment's effectiveness.
The focus is on assessing the antitumor response and overall disease control at various intervals.
Step 6
Follow-Up and Conclusion
After completing the treatment phases, the patient will undergo follow-up assessments to monitor long-term effects and overall health.
The trial is expected to conclude by April 2027, with ongoing evaluations to ensure patient safety and gather comprehensive data.

Who can join the trial?

12 criteria

Patient must be at least 18 years old at the time of signing the consent form.
Patient must be male with a type of prostate cancer called **mCRPC**. This means the cancer has spread and is resistant to standard hormone therapy.
Patient may have brain metastases, which means the cancer has spread to the brain, as long as symptoms are well controlled.
Patient should have tried at least one type of chemotherapy called **taxane-based chemotherapy** or be considered not suitable for it.
Patient should have used a newer type of hormone therapy, such as abiraterone, enzalutamide, or apalutamide.
Patient is not expected to benefit from other available treatments.
Any side effects from previous cancer treatments should have improved to a mild level, except for hair loss or nerve damage.
Patient must show signs of cancer progression, which can be an increase in **PSA** levels, changes seen in scans, or new bone lesions.
Patient should have had a procedure called **bilateral orchiectomy** (removal of both testicles) or be on continuous hormone therapy to lower testosterone levels.
Total testosterone levels should be very low, at or below 50 ng/dL.
Patient must have measurable or non-measurable signs of prostate cancer.
Patient should have a life expectancy of at least 6 months.

Who cannot join the trial?

5 criteria

Patients who do not have prostate cancer cannot participate.
Patients who are not male cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
Patients who have not been diagnosed with therapy refractory mCRPC cannot participate. Therapy refractory means that the cancer has not responded to previous treatments. mCRPC stands for metastatic castration-resistant prostate cancer, which is a type of prostate cancer that has spread to other parts of the body and does not respond to hormonal therapy.

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Verified sites

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

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain
Stichting Radboud University Medical Center
Responsive
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

LAVA-1207
is a new type of treatment being studied for its ability to target and engage specific immune cells called γδ-T cells. It is designed to recognize and attack prostate cancer cells that have become resistant to other treatments. The goal is to see if LAVA-1207 can help the immune system fight cancer more effectively.
Interleukin-2 (IL-2)
is a substance that can boost the immune system. In this trial, a low dose of IL-2 is used alongside LAVA-1207 to see if it can enhance the immune response against prostate cancer cells. IL-2 helps activate certain immune cells, potentially improving the effectiveness of the treatment.
Pembrolizumab
is a medication that helps the immune system detect and fight cancer cells. It works by blocking a specific pathway that cancer cells use to hide from the immune system. In this trial, pembrolizumab is used with LAVA-1207 to see if the combination can improve the body's ability to fight prostate cancer.

What is already known about the treatment

LAVA-1207 – This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating prostate cancer, specifically in patients with therapy-resistant metastatic castration-resistant prostate cancer. LAVA-1207 is a bispecific T cell engager that targets PSMA, a protein commonly found on prostate cancer cells, and activates gamma-delta T cells to attack these cancer cells. It is classified as an immunotherapy agent. The trials aim to assess its safety, tolerability, and effectiveness, both alone and in combination with other treatments like low-dose interleukin-2 or Pembrolizumab.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulty urinating, blood in the urine, or pelvic discomfort. In advanced stages, it may spread to bones or other parts of the body. The progression can vary greatly, with some cases remaining localized and others becoming more aggressive.