Active not recruitingPHASE2INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

This study aims to find better ways to treat rare forms of ovarian, fallopian tube, or primary peritoneal cancer that are persistent or keep coming back. We're testing several different medications, like Ipatasertib and Atezolizumab, to see how well they work and if they are safe. The treatments given will depend on specific features found in each patient’s tumour. We'll start with a smaller group of patients and might expand later if the results look promising. This research could help us find more effective and tailored treatments for these types of cancers.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

176

Start

07 Oct 2021

Estimated completion

30 May 2028

Ovarian Cancer

What is this study about?

This study is focused on a specific type of cancer that affects the ovaries, fallopian tubes, or the lining of the abdomen (primary peritoneum). Specifically, it's for less common forms of this cancer that have either come back after treatment or haven't responded to previous treatments. These can include types like low-grade serous, clear cell, or mucinous ovarian cancer, among others. The main goal is to find new and more effective ways to treat these particular cancers.

Researchers are testing several different drugs to see if they can help stop the cancer from growing or shrink it. What's special about this study is that the treatment a patient receives will depend on specific characteristics or 'markers' found in their tumour. Think of these markers as unique identifiers that tell doctors which treatment might work best for that individual's cancer. This approach is called 'biomarker-driven therapy' and aims to provide more personalised medicine.

The study will happen in two main parts: an initial phase to gather some early information, followed by a potential expansion if the treatments show promise. By carefully looking at how these new treatments affect patients and their cancers, doctors hope to discover safer and more effective options for people living with these rare and challenging conditions, ultimately improving their care.

Key takeaways

Tests new treatments for specific, recurrent ovarian/fallopian tube/peritoneal cancers.
Treatments are chosen based on individual tumour features (personalised medicine).
For patients whose cancer has returned or didn't respond to previous treatments.
Requires a tumour sample for genetic testing to guide treatment.
Participation involves several different medications like Ipatasertib, Atezolizumab, etc.
Open to women aged 18 and over with good general health.

Who may be eligible?

This study is for women aged 18 or older who have a specific type of ovarian, fallopian tube, or primary peritoneal cancer. This includes rarer forms like low-grade serous or clear cell ovarian cancer. Your cancer must have either come back or not responded well to previous treatments, and surgery isn't an option to cure it. You must have had between one and four previous treatments, including at least one that contained platinum chemotherapy.

Your cancer must be considered 'platinum-resistant,' meaning it has progressed during or within six months of your last platinum-based treatment. However, if your cancer never responded to platinum treatment initially, you wouldn't be able to join. We also need a sample of your tumour tissue to check for specific markers that will help decide which treatment arm is right for you. Your general health and organ function need to be good, as assessed by the medical team.

You cannot join if you are pregnant or breastfeeding, or if you plan to become pregnant or breastfeed during the study. If you could become pregnant, you'll need to agree to use effective birth control while on the study. There are also specific criteria for each treatment group within the study, so you must meet those extra requirements too.

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.

Am I at least 18 years old?
Do I have a rarer type of ovarian, fallopian tube, or primary peritoneal cancer that has come back or not responded to previous treatments?
Have I had one to four previous lines of treatment, including one platinum-based therapy, and is my cancer considered 'platinum-resistant'?
Am I willing to provide a tumour sample for testing?
Am I not pregnant or breastfeeding, nor planning to be during the study?
Do I have good general health and organ function (as assessed by a doctor)?

Answer every question to see your result.

What does participation involve?

Information about participation details, like visits, assessments, medication, follow-up, and total duration, is not available in the provided text. Please discuss these aspects with your doctor.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available, and close medical monitoring. However, there are also potential risks, as the new treatments may have side effects that are not yet fully known, or they may not work for everyone. You will be fully informed of any known risks. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (41)

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

UCSF Helen Diller Family CCC
Verified postcode
San Francisco, United States
Washington University School of Medicine
Verified postcode
St Louis, United States
Levine Cancer Institute
Verified postcode
Charlotte, United States
Ohio State University
Verified postcode
Columbus, United States
University of Oklahoma Health Sciences Center
Verified postcode
Oklahoma City, United States
Texas Oncology - Gulf Coast
Verified postcode
The Woodlands, United States
Virginia Oncology Associates
Verified postcode
Norfolk, United States
University of Washington - Seattle Cancer Care Alliance
Verified postcode
Seattle, United States
Cabrini Hospital
Verified postcode
Malvern, Australia
Princess Margaret Cancer Center
Verified postcode
Toronto, Canada
McGill University Health Centre - Glen Site
Verified postcode
Montreal, Canada
Gynekologicko-porodnicka klinika
Verified postcode
Prague, Czechia

Common questions

What kind of ovarian cancer is this study for?

This study is for specific, rarer types of ovarian, fallopian tube, or primary peritoneal cancer that have come back or not responded to previous treatments.

What are 'biomarker-driven therapies'?

These are treatments chosen based on specific features found in your tumour, aiming to give you a more personalised and potentially effective medicine.

Do I need to have had previous treatment for my cancer?

Yes, you must have had between one and four previous treatments, including at least one platinum-based chemotherapy, and your cancer must be considered 'platinum-resistant'.

Will I have to have a tumour sample taken?

Yes, a sample of your tumour is needed to check for specific markers that will help decide which treatment will be best for you in the study.

Can women who are pregnant participate?

No, women who are pregnant or breastfeeding, or planning to become pregnant, cannot participate in this study.