Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK 009)

This research study, called KEYLYNK 009, is for people with a specific type of breast cancer known as Triple Negative Breast Cancer (TNBC) that has either returned after treatment or spread to other parts of the body. The main goal is to find better ways to treat this cancer. The study compares two different treatment approaches: one involves two medicines called Olaparib and Pembrolizumab, and the other uses chemotherapy (like Carboplatin or Gemcitabine) along with Pembrolizumab. Researchers want to see which combination is more effective at stopping the cancer from growing, helping people live longer, and improving their overall quality of life. Participants will have already started treatment with chemotherapy and Pembrolizumab before joining this comparison part of the study.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

111

Start

10 Feb 2023

Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC)

What is this study about?

This study is designed for individuals diagnosed with a type of breast cancer known as Triple Negative Breast Cancer (TNBC). This specific type of cancer can sometimes be challenging to treat, especially if it has come back in the same area after previous treatment (locally recurrent) or has spread to other parts of the body (metastatic).

The main purpose of this research is to see if a newer treatment combination works better than current standard approaches. Participants will have already received some initial treatment with chemotherapy and a drug called Pembrolizumab (also known as KEYTRUDA). After this initial treatment, they will be randomly assigned to one of two groups. One group will continue with Pembrolizumab alongside either Carboplatin or Gemcitabine (types of chemotherapy). The other group will receive Pembrolizumab combined with a different medicine called Olaparib.

Researchers will carefully watch participants to see how well these treatments work. They'll be looking at things like how long the cancer stays under control (which doctors sometimes call "progression-free survival") and how long people live overall. Importantly, they will also evaluate how the treatments affect daily life and well-being, often described as 'quality of life'. By comparing these different aspects, the study aims to find the most effective and tolerable treatment options for people with this specific type of breast cancer.

Key takeaways

Looks at new treatment options for specific advanced breast cancer.
Compares two different drug combinations after initial treatment.
Aims to improve life expectancy and well-being.
Includes regular monitoring and check-ups.
Participation is voluntary and can be stopped at any time.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women can take part. The study is specifically for individuals who have been diagnosed with Triple Negative Breast Cancer (TNBC).

The cancer must either have returned in a localised area where it cannot be surgically removed, or it must have spread to other parts of the body. Participants would also have already started receiving initial treatment with a combination of chemotherapy and a medicine called Pembrolizumab, and their cancer should have responded well enough to this initial treatment to continue with the next phase.

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?
Have you been diagnosed with Triple Negative Breast Cancer?
Has your cancer either returned locally and is inoperable, or has it spread to other parts of your body?
Have you recently started treatment with chemotherapy and Pembrolizumab?
Has your cancer shown a good response to this initial chemotherapy and Pembrolizumab?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have already received some initial treatment. After this, you will be randomly placed into one of two treatment groups, meaning a computer decides which group you are in, like flipping a coin. You will receive either the Olaparib and Pembrolizumab combination or a chemotherapy (Carboplatin or Gemcitabine) and Pembrolizumab combination.

The study involves regular visits to the clinic for your treatments and to have check-ups. These check-ups will include physical examinations, blood tests, and scans (like CT or MRI) to see how your body is responding to the treatment and to monitor the cancer. You will also be asked to fill out questionnaires about how you are feeling and your quality of life. The total duration of your participation will depend on how you respond to the treatment and will last as long as the treatment is benefiting you, followed by a period of follow-up visits to monitor your health.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new treatment that could be more effective than current options for your cancer. However, as with all medical treatments, there are potential risks, including side effects from the medications. The research team will explain all known and possible side effects to you. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Hungary
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Unverified
Ireland
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Unverified
Spain
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Unverified
France
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Unverified
Germany
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Unverified
Poland

Common questions

What is Triple Negative Breast Cancer (TNBC)?

TNBC is a type of breast cancer that doesn't have certain receptors that are often found in other breast cancers, which means it doesn't respond to some common hormonal or targeted therapies.

What are Olaparib and Pembrolizumab?

These are medicines used to treat cancer. Pembrolizumab helps your body's immune system fight cancer, and Olaparib works by blocking a protein cancer cells need to repair themselves.

What does 'randomized' mean?

Being 'randomized' means that you'll be assigned to one of the treatment groups by chance, like drawing numbers from a hat. This helps make the study fair and scientific.

Will this study cure my cancer?

Studies like this aim to find better ways to treat cancer, but they cannot guarantee a cure. The goal is to improve how long people live and their quality of life.

What does 'quality of life' mean in this study?

Quality of life refers to how you feel physically and emotionally, and how much your cancer or its treatment affects your daily activities and well-being.