Study of Ipilimumab and Nivolumab for Patients with Metastatic Castration-Resistant Prostate Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a combination treatment for patients with prostate cancer that has become resistant to standard hormone therapy, known as castration-resistant prostate cancer. The treatment being tested includes two medications: Ipilimumab (also known by its code names BMS734016, HLX13, and IBI310) and Nivolumab (also known as BMS936558 and ABP 206). Both medications are given as a solution through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how effective this combination of medications is in treating patients with this specific type of prostate cancer. Participants in the study will receive the treatment over a period of up to 12 months. The study will monitor how the cancer responds to the treatment and will also assess the safety of the medications by observing any side effects that may occur. The goal is to determine if the combination of Ipilimumab and Nivolumab can help control the disease for more than six months.

Throughout the study, participants will undergo various assessments to track the progress of their cancer and the effects of the treatment. These assessments will include regular check-ups and tests to measure the size of the cancer and any changes in symptoms. The study aims to provide valuable information on whether this combination therapy can be a beneficial treatment option for patients with metastatic castration-resistant prostate cancer.

1 initial treatment phase

The treatment involves two medications: ipilimumab and nivolumab. Both are administered as a solution for infusion, which means they are given directly into the bloodstream through a vein.

The specific dosage and frequency of administration will be determined by the healthcare team based on individual patient needs and the study protocol.

2 monitoring and assessment

Regular monitoring will be conducted to assess the response to the treatment. This includes evaluating the disease control rate, which measures how well the disease is managed over a period of more than six months.

The healthcare team will also monitor for any side effects, particularly those that are severe (Grade 3/4 and 5).

3 biochemical and radiographic evaluation

At week 13, a biochemical response rate will be assessed, focusing on changes in prostate-specific antigen (PSA) levels, which are indicators of prostate cancer activity.

Radiographic progression-free survival will be evaluated using imaging techniques to determine if the cancer has progressed.

4 ongoing treatment and follow-up

The treatment and monitoring will continue as per the study protocol until the estimated end date of the trial, which is January 16, 2026.

Patients will be required to attend regular follow-up appointments to ensure the treatment’s effectiveness and manage any potential side effects.

Who Can Join the Study?

Provide written informed consent, which means you agree to participate in the study after being informed about it.
Have a histological diagnosis of adenocarcinoma of the prostate. If you don’t have this diagnosis, you must be willing to have a biopsy to confirm it.
Have metastatic castration-resistant prostate cancer (mCRPC), which means the cancer has spread and is not responding to treatments that lower testosterone.
Have an immunogenic phenotype, which includes one of the following:
- Mismatch repair deficiency or a high number of mutations in the cancer cells.
- BRCA2 inactivation or a specific genetic signature related to BRCA genes.
- A tandem duplication signature, which is a specific pattern in the DNA.
Be at least 18 years old.
Have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
Have a PSA level of at least 2 ng/ml. PSA is a protein produced by the prostate, and higher levels can indicate prostate cancer.
Agree to use an effective means of contraception during the study and for 7 months after the last dose of treatment.
Have ongoing castrate serum testosterone levels below 50 ng/dL, meaning low testosterone levels due to treatment.
Have received prior castration by surgery or ongoing treatment with Luteinizing Hormone-Releasing Hormone (LH-RH) agonists, which are medications that lower testosterone.
Show progression of disease by PSA levels and at least one of the following:
- Progression seen on a bone scan with at least 2 new lesions.
- Progression of soft tissue disease as defined by specific criteria.
- Worsening pain and need for palliative radiotherapy for bone metastases.
Have a biopsiable metastatic lesion and be willing to undergo a biopsy before and during treatment for further analysis.

Who Cannot Join the Study?

Patients who do not have castration-resistant prostate cancer cannot participate. This is a type of prostate cancer that continues to grow even when the amount of male hormones in the body is reduced to very low levels.
Only male patients can participate. Female patients are not eligible.
Patients who are part of a vulnerable population are not eligible. This means people who might be at a higher risk of harm or exploitation, such as those with limited ability to make decisions for themselves.
Patients who do not meet the age requirements cannot participate. The specific age range is not provided, but it is important to be within the required age group.
Patients who do not belong to the specified clinical trial group are not eligible. This refers to a specific group of patients that the study is focusing on.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Snujvirdm Rryssed Uikehojwor Mwtaezf Cjkgfl	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	18.01.2021

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, it is being used to treat patients with metastatic castration-resistant prostate cancer.

Ipilimumab is another immune checkpoint inhibitor. It helps to boost the immune system’s response against cancer cells. In this study, it is used in combination with nivolumab to enhance the treatment effects for patients with metastatic castration-resistant prostate cancer.

Investigated diseases:

Hormone-refractory prostate cancer

Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to progress despite the reduction of male hormones that fuel the growth of prostate cancer cells. It typically occurs after treatments that lower testosterone levels, such as surgery or medication, have been administered. The cancer may spread to other parts of the body, including bones and lymph nodes. Patients may experience symptoms such as difficulty urinating, bone pain, and fatigue. The disease is characterized by its resistance to conventional hormone therapy, making it more challenging to manage. It often requires additional therapeutic strategies to control its progression.

Trial ID:

2024-513186-39-01

NCT ID:

NCT04717154

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ipilimumab and Nivolumab for Patients with Metastatic Castration-Resistant Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?