Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)
This study is exploring how well and how safely a drug called olaparib (also known as MK-7339) works by itself in people with advanced solid cancers. These are cancers that cannot be removed by surgery or have spread. The study is for patients whose cancer has not improved with standard treatments or who couldn't tolerate them. Critically, participants' tumours must have specific changes in their genes related to how cells repair themselves (called homologous recombination repair mutations or HRD). By targeting these specific genetic changes, researchers hope to find new ways to treat these difficult cancers. The study is particularly looking at various types of advanced cancers beyond just ovarian or breast cancer, where olaparib is already used.
At a glance
What is this study about?
This research study is looking into a drug called olaparib, which is already used for some types of cancer, but this study is for people with advanced solid cancers that have specific gene changes. 'Advanced' means the cancer has spread or can't be removed by surgery. The study is designed for patients whose usual cancer treatments haven't worked or who couldn't cope with them.
The key to this study is something called 'homologous recombination repair mutation' (HRRm) or 'homologous recombination deficiency' (HRD). These are fancy terms for specific changes in the cancer cells' genes that affect how the cells repair themselves. Olaparib is a type of drug that works by attacking cancer cells with these particular gene changes, causing the cancer cells to die. By finding out if olaparib works for different types of advanced cancers with these genetic changes, scientists hope to offer new treatment options where others have failed.
Taking part would mean you would receive olaparib as the only treatment to see how effective it is and if it's safe. This is a "Phase 2" study, which means it builds on earlier research and aims to confirm the drug's benefits for this specific group of patients, paving the way for it to potentially become a more widely available treatment for these challenging cancers.
Key takeaways
- Tests a new use for olaparib in advanced solid cancers.
- Specifically for cancers with certain gene changes (HRRm or HRD).
- For patients whose current treatments haven't worked.
- Olaparib would be the only cancer treatment received in the study.
- Close monitoring for safety and effectiveness is part of the study.
Who may be eligible?
To join this study, your cancer needs to be advanced (meaning it has spread or can't be removed surgically) and standard treatments haven't worked or weren't tolerated. An important part is that your cancer cells must have specific changes in their genes that affect how they repair themselves. We would check for these changes using a sample of your tumour tissue.
You also need to be at least 18 years old and generally well enough to take part, with a life expectancy of at least 3 months. This means your body organs need to be working properly, and you should be able to manage day-to-day activities quite well. We'll also need to be able to measure your cancer to see if the treatment is working.
There are also some rules about contraception during the study. If you're a man, you must use contraception and not donate sperm for several months. If you're a woman, you must not be pregnant or breastfeeding, and if you could become pregnant, you need to use very reliable contraception or avoid sex for a long time during and after the study.
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.
- Is my cancer advanced (spread or unresectable)?
- Have my previous cancer treatments stopped working or caused too many side effects?
- Has my doctor tested my tumour for specific gene changes like HRRm or HRD?
- Am I over 18 and generally well enough for a study, with a life expectancy of at least 3 months?
- Am I willing to follow strict contraception rules if I or my partner could become pregnant?
What does participation involve?
If you join the study, you would receive the drug olaparib. While the detailed activities aren't fully described here, typically, this type of study involves regular visits to the clinic for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. You'd be given the study drug and closely monitored by the medical team.
Contraception rules are strict: men must use contraception during treatment and for over 3 months after the last dose, and not donate sperm. Women who can get pregnant must use highly effective contraception or abstain from sex during treatment and for about 6 months after the last dose, and not donate eggs. You also must not breastfeed during the study and for a month after the last dose. The overall length of your participation would depend on how you respond to the treatment and the study plan, but you will always have the right to withdraw at any time.
Potential risks and benefits
Locations (130)
- The University of Arizona Cancer Center - North Campus ( Site 0011)Verified postcodeTucson, United States
- St Joseph Heritage Healthcare-Oncology ( Site 0056)Verified postcodeFullerton, United States
- Cedars Sinai Medical Center ( Site 0002)Verified postcodeLos Angeles, United States
- UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)Verified postcodeSan Francisco, United States
- Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)Verified postcodeAurora, United States
- Winship Cancer Institute of Emory University ( Site 0025)Verified postcodeAtlanta, United States
- Augusta University ( Site 0028)Verified postcodeAugusta, United States
- Markey Cancer Center ( Site 0018)Verified postcodeLexington, United States
- University of Maryland ( Site 0050)Verified postcodeBaltimore, United States
- Weinberg Cancer Institute at Franklin Square ( Site 0054)Verified postcodeBaltimore, United States
- University of Massachusetts ( Site 0017)Verified postcodeWorcester, United States
- Henry Ford Health System ( Site 0060)Verified postcodeDetroit, United States
Common questions
What is olaparib?
Olaparib is a medicine that targets cancer cells with specific gene faults, making them unable to repair themselves and causing them to die.
What does 'advanced solid cancer' mean?
It means the cancer has grown or spread beyond its original site and cannot be removed by surgery, or has already spread to other parts of the body.
What are HRRm or HRD?
These refer to specific changes in the genes of your cancer cells that affect how the cells repair damage. Olaparib is designed to work against cancers with these changes.
Will I get any other cancer treatment if I join this study?
No, in this study, olaparib will be given as the only treatment (monotherapy) to see how well it works by itself.
How long would I be on the study plan?
The exact duration isn't specified, but it would involve ongoing treatment with regular check-ups and monitoring for as long as the treatment is benefiting you safely.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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