A Phase 2 Study of Olaparib in Combination with Pembrolizumab in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer
This study is a Phase 2 clinical trial exploring new ways to treat advanced cancer that has certain genetic changes, known as HRRm and/or HRD-positive. Researchers are testing a combination of two drugs, olaparib and pembrolizumab (also known as KEYTRUDA). The main goal is to see how many patients experience a shrinkage of their tumour after receiving this treatment. They will also look at how long the treatment keeps the cancer from growing, how long people live, and any side effects. This research aims to understand if this drug combination could be a good option for specific types of cancer that have these genetic markers.
At a glance
What is this study about?
This study is a Phase 2 clinical trial looking into a new treatment approach for people with advanced cancer. Advanced cancer means the cancer has spread or come back after previous treatments. The trial focuses on cancers that have specific genetic changes, called Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive. Simply put, these are changes in how cancer cells repair themselves, which might make them more vulnerable to certain treatments.
Researchers are combining two different medicines in this study: olaparib and pembrolizumab (which you might know as KEYTRUDA). Olaparib works by targeting a cancer cell's ability to repair its DNA, while pembrolizumab helps your immune system fight the cancer. The idea is that using these two drugs together might be more effective than using either one alone for cancers with these specific genetic features.
The main purpose of this study is to see how many patients respond to the treatment, meaning their tumours shrink or stop growing. They will also track how long the treatment keeps the cancer under control (progression-free survival), how long people live overall (overall survival), and monitor any side effects that might occur. This information helps doctors understand if this combination therapy could be a promising new option for people living with these particular kinds of advanced cancer.
Key takeaways
- This study investigates a new combination treatment for advanced cancer with specific genetic changes.
- It combines two medicines, olaparib and pembrolizumab (KEYTRUDA).
- The main goal is to see if the treatment shrinks tumours and improves health.
- The study is for adults (18+) who have received previous cancer treatment.
- Potential benefits include a new treatment option, but side effects are possible.
- Participation involves regular clinic visits for treatment and monitoring.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women are welcome to take part.
The study is specifically for people whose advanced cancer has certain genetic changes, known as HRRm and/or HRD-positive. A doctor would need to perform tests to confirm if your cancer has these specific features.
As this study is for advanced cancer, participants would have already received some form of treatment for their cancer in the past.
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?
- Has your cancer been previously treated?
- Has your doctor told you your cancer is 'advanced'?
- Have tests confirmed your cancer has HRRm and/or HRD-positive genetic changes?
What does participation involve?
If you decide to take part in this study, you will receive treatment with both olaparib and pembrolizumab. Olaparib is given as a medicine you take, while pembrolizumab is given through an IV drip, typically at a clinic or hospital. The exact schedule for these treatments and how long you receive them will be explained by the study team.
You will have regular visits to the clinic for medical checks, blood tests, and scans to see how you are responding to the treatment. These visits help the doctors monitor your health and the effects of the medicines. The study team will explain how often these visits will be and what each visit involves. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will be kept informed every step of the way.
Potential risks and benefits
Locations (8)
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Common questions
What does 'advanced cancer' mean?
It means the cancer has spread from where it started or has come back after previous treatments.
What are HRRm and HRD-positive cancers?
These refer to specific genetic changes in cancer cells that affect how they repair their DNA. The study focuses on cancers with these particular features.
What is a 'Phase 2' study?
A Phase 2 study tests if a new treatment looks promising for specific conditions and helps determine the right dose and how safe it is.
Will I know if the treatment is working?
Yes, the study team will perform regular scans and tests to check how your body and the cancer are responding to the treatment.
What if I experience side effects?
The study team will closely monitor you and provide care for any side effects you might experience. You should report any new or worsening symptoms immediately.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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