Study of Nivolumab, Ipilimumab, or Cabazitaxel for Men with Advanced Prostate Cancer Resistant to Hormone Therapy

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What is this study about?

This clinical trial is focused on studying treatments for Metastatic Castration-Resistant Prostate Cancer, a type of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. The study involves three different treatments: Nivolumab combined with Ipilimumab, Ipilimumab alone, and Cabazitaxel. Nivolumab and Ipilimumab are medications that help the immune system fight cancer, while Cabazitaxel is a chemotherapy drug that works by stopping cancer cells from growing and dividing.

The purpose of the study is to evaluate how well these treatments work in men with this type of prostate cancer. Participants in the study will receive one of the treatments, and their progress will be monitored over time. The study will look at how the cancer responds to the treatment, how long participants live without the cancer getting worse, and any side effects they may experience. The study will also assess the overall health and quality of life of the participants during the treatment period.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the effects of the treatment. These may include imaging tests like MRI or CT scans to see how the cancer is responding, as well as blood tests to check for any changes in health. The study aims to provide valuable information on the effectiveness and safety of these treatments for men with Metastatic Castration-Resistant Prostate Cancer.

1 initial visit and consent

Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide your consent to participate. This involves signing a document that confirms you understand the study and agree to take part.

2 screening and baseline assessments

You will undergo a series of tests to ensure you meet the study’s eligibility criteria. These tests may include blood tests, imaging scans like CT or MRI, and assessments of your overall health status.

3 treatment assignment

You will be randomly assigned to one of the treatment groups. The treatments being studied include nivolumab plus ipilimumab, ipilimumab alone, or cabazitaxel. The assignment is random to ensure fairness and scientific accuracy.

4 treatment administration

If you are assigned to the nivolumab plus ipilimumab group, you will receive these medications through an intravenous infusion. Nivolumab is given as a solution for infusion, and ipilimumab is given as a concentrate for solution for infusion.

If you are assigned to the ipilimumab alone group, you will receive ipilimumab through an intravenous infusion.

If you are assigned to the cabazitaxel group, you will receive cabazitaxel through an intravenous infusion. The specific dosage and frequency will be explained to you by the study team.

5 regular follow-up visits

You will have regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical exams, blood tests, and imaging scans to assess the progress of your condition.

6 completion of treatment

Once you have completed the treatment phase, you will have a final set of assessments to evaluate the overall impact of the treatment on your condition.

7 long-term follow-up

After completing the treatment, you may be asked to participate in long-term follow-up visits. These visits help the study team gather information on the long-term effects and benefits of the treatment.

Who Can Join the Study?

Must have a diagnosis of Metastatic Castration-Resistant Prostate Cancer.
Must have an ECOG performance status of 0-1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
Must have current evidence of metastatic disease, which means the cancer has spread to other parts of the body. This can be shown by bone lesions on a bone scan or soft tissue lesions on a CT or MRI scan.
Must be undergoing androgen deprivation therapy (ADT), which is a treatment to lower testosterone levels. This can be done with medication called a Gonadotropin-releasing hormone (GnRH) analogue or through surgical/medical castration. The testosterone level must be 1.73 nmol/L (50 ng/dL) or lower.
For those in the crossover phase who were originally in Arm D3 or Arm D4: Must have been previously randomized to Arm D3 or D4, have a confirmed diagnosis of prostate cancer, and evidence of Stage IV disease before randomization.
Must be male.

Who Cannot Join the Study?

Patients who do not have Metastatic Castration-Resistant Prostate Cancer cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
Only male patients can participate. Female patients are not eligible.
Patients who are part of a vulnerable population are not eligible. This means groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Klinikum Nuernberg	Nürnberg	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Wissenschaftskontor Nord GmbH & Co. KG	Rostock	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	28.06.2017

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, Nivolumab is being tested to see if it can help treat prostate cancer that has spread and is resistant to standard hormone therapy.

Ipilimumab is another immune checkpoint inhibitor. It helps activate your immune system to fight cancer by targeting a specific protein that usually helps keep the immune system in check. This trial is exploring whether Ipilimumab alone or in combination with Nivolumab can be effective in treating advanced prostate cancer.

Cabazitaxel is a chemotherapy drug used to treat prostate cancer that has spread and is no longer responding to hormone therapy. It works by interfering with the growth and division of cancer cells, ultimately leading to their death. This trial is investigating how well Cabazitaxel works compared to the other treatments being studied.

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread despite treatments that lower testosterone levels. It is characterized by the cancer’s ability to metastasize, or spread, to other parts of the body, such as bones and lymph nodes. The disease progresses as cancer cells become resistant to hormonal therapies that are typically used to control prostate cancer growth. Over time, the cancer may cause symptoms such as pain, urinary issues, and fatigue. The progression of the disease can be monitored through imaging tests and blood markers. As the cancer advances, it may lead to more severe symptoms and complications.

Trial ID:

2022-502909-15-00

Protocol code:

CA209650

NCT ID:

NCT02985957

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Nivolumab, Ipilimumab, or Cabazitaxel for Men with Advanced Prostate Cancer Resistant to Hormone Therapy

What is this study about?

Who Can Join the Study?

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