Active not recruitingPHASE2INTERVENTIONAL

Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

This study is for women who have a specific type of ovarian cancer that has returned, even after they were treated with a type of drug called a PARP inhibitor. Researchers want to see if combining a new medicine called tuvusertib with either niraparib or lartesertib is safe and effective in shrinking the cancer or stopping it from growing. We will compare these combinations to tuvusertib on its own. The study specifically looks at how tumours respond to these new treatments and any side effects. To join, you would need to have certain genetic changes in your cancer (like BRCA1 or BRCA2 mutations) or other specific features showing how your body repairs DNA.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrolment target

Start

30 Oct 2024

Estimated completion

14 Jun 2026

Ovarian Cancer

What is this study about?

This study is looking into new ways to treat a type of ovarian cancer that has returned. Specifically, it's for women whose cancer has progressed after they've already received a treatment called a PARP inhibitor. PARP inhibitors are medicines that work by targeting cancer cells' ability to repair themselves, but sometimes the cancer can find ways around this. This trial explores if combining a new experimental drug called tuvusertib with either niraparib (which is a type of PARP inhibitor) or lartesertib could be more effective. The study also wants to compare these combination treatments to tuvusertib given alone.

The main goal is to find out if these new treatments can help shrink the cancer or stop it from growing, and importantly, to understand any side effects they might cause. By testing these combinations, doctors hope to find better options for women whose ovarian cancer has become resistant to previous PARP inhibitor treatments. This research is important because it could lead to new ways to manage recurrent ovarian cancer and improve the lives of patients in the future.

It's important to remember that this is a research study, and new treatments are being tested. The medical team will closely monitor all participants to ensure their safety and track how their cancer responds to the study medicines.

Key takeaways

This study is for women with recurrent ovarian cancer.
It's for people whose cancer has progressed after PARP inhibitor treatment.
The study tests new drug combinations (tuvusertib with niraparib or lartesertib).
It aims to see how safe and effective these new treatments are.
You need certain genetic changes in your cancer to be eligible.

Who may be eligible?

This study is for women aged 18 or over who have a specific type of ovarian cancer called high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer that has come back. For your cancer to be eligible, it needs to show certain genetic changes, such as mutations in the BRCA1 or BRCA2 genes, or have a specific feature called 'HRD positive'. These will be checked by your doctor using standard tests.

You must have experienced your cancer getting worse while you were taking a PARP inhibitor medicine, or shortly after stopping it. You also would have needed to benefit from the PARP inhibitor for at least six months before the cancer started to grow again. Depending on when your cancer progressed while on PARP inhibitors, you might have had one additional round of chemotherapy, but there are specific time requirements for this.

Finally, you should either be unable to have standard treatments, have chosen not to have them, or your doctor feels that not having standard treatment is acceptable for your situation. Please talk to your doctor who can review your full medical history and test results to see if this study could be right for you.

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?
Do you have high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer that has returned?
Has your cancer progressed after being treated with a PARP inhibitor?
Does your cancer have specific genetic changes like BRCA1/2 mutations or HRD positive status?
Did you benefit from your PARP inhibitor for at least 6 months before progression?
Are you unable to have standard treatments, or has your doctor agreed to this study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given a combination of medicines: tuvusertib combined with either niraparib or lartesertib. Some participants might receive tuvusertib on its own. The study team will assign you to one of these treatment groups. You'll need to visit the study clinic regularly for tests, scans, and to discuss any side effects you might be having. These visits will help the doctors understand how the treatment is working and make sure you're safe. We don't have information on the exact number of visits or the total length of the study from the summary, but clinical trials usually involve frequent initially, gradually spacing out over time. You would continue treatment as long as it is benefiting you and you are not experiencing severe side effects.

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; the experimental drugs might cause side effects, some of which could be serious, and the treatment might not work for everyone. You will be told about all known side effects during the consent process. It’s important to remember that participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (84)

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

University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States
University of California San Francisco - UCSF Medical Center
Verified postcode
San Francisco, United States
Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research
Verified postcode
Columbus, United States
University of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies Pavilion
Verified postcode
Chicago, United States
University of Michigan Rogel Cancer Center
Verified postcode
Ann Arbor, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME
Verified postcode
New York, United States
Next Oncology - Virginia
Verified postcode
Fairfax, United States
Virginia Cancer Specialists, PC
Verified postcode
Fairfax, United States
Chris O'Brien Lifehouse
Verified postcode
Camperdown, Australia
St George Private Hospital
Verified postcode
Kogarah, Australia
Liverpool Hospital - PARENT
Verified postcode
Liverpool, Australia

Common questions

What is ovarian cancer?

Ovarian cancer is a type of cancer that starts in the ovaries, which are part of a woman's reproductive system.

What are PARP inhibitors?

PARP inhibitors are a type of medicine that helps stop cancer cells from repairing themselves, leading to their death. They are used in some ovarian cancers.

What does 'recurrent' mean?

Recurrent means that the cancer has come back after it was treated and was previously in remission.

What are BRCA1 and BRCA2 genes?

These are genes that play a role in repairing damaged DNA. Mutations in these genes can increase the risk of certain cancers, including ovarian cancer.

Will I definitely get one of the new combination treatments?

If you qualify and join, you will be assigned to receive tuvusertib with either niraparib or lartesertib, or tuvusertib on its own. The study team will decide which group you are in.