Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer

This study is for men with advanced prostate cancer that has spread and is no longer responding to standard hormone therapy. It's a 'Phase 2' trial, meaning it's still in the earlier stages of testing new treatments. Researchers are comparing three different approaches: two involve a combination of drugs called nivolumab and ipilimumab or ipilimumab alone, which are designed to boost the body's own immune system to fight cancer. The third group receives a chemotherapy drug called cabazitaxel. The main aim is to see how well these treatments shrink tumours and slow down the cancer's growth, while also looking at side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

Start

10 Aug 2023

Metastatic Castration-Resistant Prostate Cancer

What is this study about?

This research study is designed for men who have advanced prostate cancer. This means the cancer has spread to other parts of the body (metastasised) and is no longer responding to hormone therapy, which is a common initial treatment. In this situation, doctors are always looking for new and more effective ways to treat the cancer.

The study is called a 'Phase 2' trial. This means that the treatments have already been tested for safety in a smaller group of people (Phase 1), and now researchers want to see how well they work and if they have acceptable side effects in a larger group. It's a step towards finding new standard treatments, but it's important to remember these are still experimental.

The main goal of the study is to see if these new treatments can shrink the cancer (this is called 'objective response rate') and how long it takes before the cancer starts to grow or spread again ('radiographic progression-free survival'). Researchers will also be carefully monitoring for any side effects and how the treatments affect patients' quality of life.

Key takeaways

This study explores new treatments for advanced prostate cancer that has stopped responding to hormone therapy.
It's a Phase 2 trial, focusing on how well treatments work and their potential side effects.
Participants will receive either immunotherapy (nivolumab plus ipilimumab, or ipilimumab alone) or chemotherapy (cabazitaxel).
Regular clinic visits, tests, and questionnaires are part of taking part.
The main goals are to measure tumour shrinkage and how long cancer growth is kept in check.
Participation is voluntary, and you can stop at any time.

Who may be eligible?

To join this study, people must be adult men, aged 18 or older. There isn't an upper age limit, so older men can also take part if they meet other criteria.

Participants must have prostate cancer that has spread to other parts of the body and is no longer being controlled by standard hormone therapy. This means your cancer is considered 'metastatic castration-resistant prostate cancer'.

There will be other detailed medical criteria that your doctor will check to make sure the study is safe and appropriate for you, such as your general health, organ function, and previous treatments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult man (18 years or older)?
Do you have prostate cancer that has spread to other parts of your body?
Has your prostate cancer stopped responding to hormone therapy?
Are you generally well enough to participate in a clinical trial activities?
Are you able to attend regular clinic appointments and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to one of three treatment groups: receiving nivolumab plus ipilimumab, ipilimumab alone, or cabazitaxel. You would receive these treatments as infusions (directly into your vein).

You would have regular visits to the clinic for medical check-ups, blood tests, and scans (like X-rays or CT scans) to monitor your cancer and check for any side effects. You would also fill out questionnaires to assess your pain, how you're feeling generally, and your quality of life.

The study would involve regular appointments and assessments for a specific period, which your doctor will explain. After treatment, there would also be follow-up appointments to track your long-term health and the progress of your cancer.

Potential risks and benefits

Potential benefits of joining the study could include access to new treatments before they are widely available and potentially improved control of your cancer. However, there's no guarantee the treatments will work for everyone, and some may not experience any benefit. Like all medicines, these experimental treatments can have side effects, ranging from mild to serious. The study team will monitor you closely for any unwanted effects. It's important to remember that participating is entirely voluntary, and you can withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Germany

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This means your prostate cancer has spread to other parts of your body (metastatic) and is no longer being controlled by hormone therapies that reduce testosterone (castration-resistant).

What does 'Phase 2' mean for a clinical trial?

A Phase 2 trial means researchers are testing new treatments to see how well they work and to learn more about side effects, after initial tests have shown they are safe enough to study further.

What are nivolumab and ipilimumab?

These are types of immunotherapy drugs that work by helping your body's own immune system find and fight cancer cells.

What is cabazitaxel?

Cabazitaxel is a chemotherapy drug that works by stopping cancer cells from growing and dividing.

Will I know which treatment I'm getting?

Your study doctor will be able to explain if you will know which treatment you are receiving or if it's assigned randomly among the study treatments.