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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Iwnxyein Cjnpzv Dsrzmcibvvplppdfq	L'hospitalet De Llobregat	Spain
Stcpkmegf Rzqshwp Ucfaitxhiw Mptbmig Ctqpta	Nijmegen	The Netherlands
Ewvhrip Unjpaknyhlwk Mhkimqx Clwssgl Ryjgmqlmy (qxrmind Mlv	Rotterdam	The Netherlands
Arlrgogsj Ukg	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	15.11.2021
The Netherlands	Not recruiting	15.11.2021

Trial locations

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.

Investigated diseases:

Prostate cancer metastatic

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.

Trial ID:

2024-515821-27-00

NCT ID:

NCT05369000

Trial Phase:

Human Pharmacology (Phase I) – Other

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

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