Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase II trial of Pembrolizumab and Olaparib in homologous-recombination deficient (HRD) advanced colorectal cancer (CRC).

This clinical trial is investigating a new treatment approach for advanced bowel cancer. Specifically, it's for people whose cancer has a particular genetic fault called 'homologous-recombination deficiency' (HRD). The study aims to see how effective a combination of two drugs, Pembrolizumab (also known as KEYTRUDA) and Olaparib, is at shrinking tumours or stopping their growth. Researchers will measure how many patients respond to the treatment, how long the cancer stays under control, and how long people live. This is a Phase II study, meaning it's exploring whether the treatment works and is safe enough to study further.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Grupo Espanol Multidisciplinar En Cancer Digestivo

Enrolment target

Start

03 Jul 2024

Colorectal cancer

What is this study about?

This research study is looking for better ways to treat advanced bowel cancer. Advanced bowel cancer means the cancer has spread from where it started. Scientists have found that some bowel cancers have a specific weakness in their genetic code, called 'homologous-recombination deficiency' (HRD). This study is designed specifically for people whose bowel cancer has this particular weakness.

The trial is testing a combination of two different medicines: Pembrolizumab (also known by its brand name, KEYTRUDA) and Olaparib. Pembrolizumab works by helping your body's immune system fight the cancer. Olaparib is a type of drug that targets cancer cells with certain genetic weaknesses, like HRD, making it harder for them to repair themselves.

The main goal of this study is to see how many patients respond to this combined treatment – meaning, how many see their tumours shrink or stop growing. The researchers will also look at how long the cancer remains under control, how long patients live, and how long any response to the treatment lasts. This is a 'Phase II' study, which means it's an important step to see if this new treatment combination is effective enough and safe enough to be tested in even larger studies in the future.

Key takeaways

This study is for advanced bowel cancer with a specific genetic weakness (HRD).
It combines two drugs: Pembrolizumab (KEYTRUDA) and Olaparib.
The main goal is to see if the treatment shrinks tumours or stops growth.
It's a Phase II study, exploring effectiveness and safety.
Participation involves regular hospital visits and health checks.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women. The most important requirement is that you must have advanced bowel cancer that has been identified as having a specific genetic weakness called 'homologous-recombination deficiency' (HRD).

There might be other health requirements or previous treatments that could affect whether you can join, but these would be discussed in detail by the study team. They will carry out several tests to make sure the study is right for you and that you meet all the safety criteria.

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 18 years old or older?
Do you have advanced bowel cancer?
Has your cancer been tested for a genetic weakness called HRD?
Are you willing to have regular hospital visits and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the two study drugs: Olaparib and Pembrolizumab. Pembrolizumab is given as a liquid through a drip into your vein (an infusion), while Olaparib is typically taken as tablets or capsules. The study team would explain exactly how and when you would receive these treatments.

Throughout your time on the trial, you would have regular visits to the hospital or clinic. These visits would involve various checks to see how you are responding to the treatment and to monitor for any side effects. These checks might include blood tests, scans (like CT or MRI scans) to measure the cancer, and physical examinations. You would also have follow-up visits after the treatment period has ended to see how you are doing in the longer term. The total duration of your participation would depend on how your cancer responds to the treatment and the study's follow-up plan, which your doctor would explain clearly.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new treatments before they are widely available, which may be more effective for your specific type of cancer. However, there are also potential risks involved, as new treatments can have side effects that are not fully known or may be different from standard treatments. You might experience side effects from the drugs, and there's no guarantee the treatment will work for you. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What does 'advanced bowel cancer' mean?

It means the cancer has spread from where it started to other parts of the body.

What is 'HRD'?

HRD stands for 'homologous-recombination deficiency,' which is a specific genetic weakness found in some cancer cells.

What are Pembrolizumab and Olaparib?

They are cancer medicines. Pembrolizumab boosts your immune system, and Olaparib targets cancer cells with certain genetic faults.

What is a Phase II trial?

It's a stage of research that checks if new treatments are effective and safe enough to be studied further in larger groups of people.

Will this treatment cure my cancer?

Clinical trials explore new treatments. While the aim is to improve outcomes, specific cures cannot be guaranteed.