Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

OPAL Master Protocol: A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments and/or Combinations of Treatments in Participants with Ovarian Cancer (OPAL) (PR-3000-02-005/213357) Cohort C: Open-label Phase 2, Randomized, Controlled Multicenter Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants with Homologous Recombination- Deficient Stage III/IV Ovarian Cancer

This study, called OPAL, is researching new treatments for advanced ovarian cancer. Specifically, one part of the study (Cohort C) is focusing on women with Stage III or IV ovarian cancer where their tumour has a specific genetic weakness (called 'homologous recombination-deficient'). It's comparing a new drug, niraparib (Zejula), with the usual combination of chemotherapy drugs given before surgery (carboplatin and paclitaxel). Researchers will also look at whether adding another drug, bevacizumab (Avastin), makes a difference. The aim is to find out if these new approaches are safe and more effective at shrinking tumours before surgery than current treatments, ultimately improving outcomes for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Tesaro Inc.

Enrolment target

Start

07 Feb 2024

Ovarian Neoplasms

What is this study about?

This study, known as the OPAL trial, is exploring new ways to treat advanced ovarian cancer. Ovarian cancer is when abnormal cells grow in the ovaries, and 'advanced' means it has spread beyond the ovaries to other parts of the body. This particular part of the study focuses on women who have Stage III or IV ovarian cancer and whose tumours have a specific genetic feature known as 'homologous recombination-deficient' (HR-deficient). This genetic feature means the cancer cells have trouble repairing themselves, which can make them more sensitive to certain treatments.

The main goal of this study is to compare a new treatment approach with the standard treatment given before surgery. The new approach involves a drug called niraparib, sometimes used with another drug called bevacizumab. This will be compared to the usual chemotherapy, which typically includes drugs like carboplatin and paclitaxel. By understanding how well tumours shrink with each treatment, and how patients feel, doctors hope to identify better ways to help women with this type of ovarian cancer.

Throughout the study, doctors will be carefully checking how well the treatments work by measuring tumour size, looking at blood tests (like CA-125 levels), and seeing how long patients live without their cancer getting worse or reappearing. They will also pay close attention to any side effects and how treatments affect a patient's quality of life. This helps them understand not just if a treatment is effective, but also how it impacts daily living.

Key takeaways

This study is for women with advanced ovarian cancer that has a specific genetic feature.
It compares a new drug (niraparib) with standard chemotherapy before surgery.
Researchers want to see which treatment works better at shrinking tumours and is safer.
Your quality of life and side effects will be carefully monitored.
Participating helps advance knowledge about ovarian cancer treatment.

Who may be eligible?

To be considered for this study, you would need to be a woman aged 18 years or older. You must have been diagnosed with ovarian cancer that is considered advanced (Stage III or IV).

Additionally, your ovarian cancer must have a specific genetic feature, which doctors call 'homologous recombination-deficient' (HR-deficient). This is a technical term but essentially means your cancer cells have a particular weakness that could make certain treatments more effective.

Your general health will also be checked to make sure you are well enough to take part in the study and to receive the treatments involved.

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 a woman aged 18 or older?
Do you have advanced ovarian cancer (Stage III or IV)?
Has your doctor confirmed that your cancer has the 'homologous recombination-deficient' (HRD) feature?
Are you generally well enough to undergo cancer treatment?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would be randomly assigned to receive either the new treatment (niraparib, potentially with bevacizumab) or the standard chemotherapy (carboplatin and paclitaxel). Random assignment means you wouldn't choose which group you're in, similar to a coin toss. You would receive these treatments before having surgery.

Throughout the study, you would attend regular clinic visits where doctors would check your health, conduct blood tests, and perform scans to see how the treatment is working and monitor for any side effects. You might also fill out questionnaires about your well-being and quality of life. The exact number of visits and tests would be discussed with you by the study team, and you'll have ongoing support.

Potential risks and benefits

Potential benefits of taking part might include access to a new treatment that isn’t yet widely available, which could be more effective for your type of ovarian cancer. Your participation also helps doctors learn more about ovarian cancer treatment, which could help future patients. However, there are potential risks, as with any medical treatment. Drugs like niraparib, carboplatin, paclitaxel, and bevacizumab can have side effects, which the study team will discuss with you in detail. You will be closely monitored for these. It is very important to remember that joining a clinical study is entirely voluntary, and you have the right to withdraw at any time, for any reason, without it 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
Spain

Common questions

What is 'advanced' ovarian cancer?

Advanced ovarian cancer means the cancer has spread beyond the ovaries to other parts of your body. This study focuses on cancers that have reached Stage III or Stage IV.

What does 'homologous recombination-deficient' mean?

It's a specific genetic feature in some ovarian cancers. It means your cancer cells have a problem repairing their DNA, which can make them more sensitive to certain medications, like the one being tested in this study.

What is 'neoadjuvant treatment'?

This is treatment given before the main treatment, which in this case is surgery. The aim is often to shrink the tumour first to make surgery more effective.

Will I know which treatment I'm getting?

Yes, in this study, you and your doctors will know which treatment you are receiving. This is called 'open-label'.

How long will I be in the study?

The duration of your active treatment and follow-up will vary, but the study team will explain the full timeline to you before you agree to participate.