Active not recruitingPHASE3INTERVENTIONAL

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

This research study is looking for women recently diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer. These women would have already completed their first course of chemotherapy and surgery and have responded well to it. The study aims to see if two specific medications, rucaparib and nivolumab, given as 'maintenance treatment' (meaning treatment to keep the cancer from coming back), are effective. This is a Phase 3 study, which means it's one of the final stages of testing before a new treatment might become widely available. Participants will be randomly assigned to receive either one of the study drugs or a placebo (a dummy treatment) to fairly compare their effects. The main goal is to understand if these drugs can help women stay cancer-free for longer after their initial treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

pharmaand GmbH

Enrolment target

1,097

Start

14 May 2018

Estimated completion

30 Dec 2030

Epithelial Ovarian Cancer Primary Peritoneal Fallopian Tube Cancer Newly Diagnosed FIGO Stage III-IV Partial Response Complete Response

What is this study about?

This research is looking at new ways to help women who have been diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer. These types of cancer often require significant treatment, usually starting with chemotherapy and surgery. The good news is that many women respond well to this initial treatment, meaning the cancer shrinks or goes away. This study is for those women who have had a good response.

The main idea behind this study is to find out if giving certain medications *after* the initial treatment can help keep the cancer from coming back or growing. This is called 'maintenance treatment.' The study is testing two different drugs, rucaparib and nivolumab. Rucaparib is a tablet that works by targeting specific ways cancer cells repair themselves, while nivolumab is given through a drip and helps your body's immune system fight cancer. We want to see if one or both of these drugs, compared to a dummy treatment, can improve how long women stay well after their first round of therapy.

This is a very important study because it's a 'Phase 3' trial. This means it's one of the last steps in testing new treatments thoroughly before they can be considered for wider use. By taking part, you could be helping us learn more about the best ways to care for women with ovarian cancer in the future and potentially help develop new and better treatments.

Key takeaways

This study is for women with advanced ovarian, fallopian tube, or primary peritoneal cancer.
It's for those who have responded well to their first round of chemotherapy and surgery.
It tests two drugs (rucaparib and nivolumab) as 'maintenance treatment' to prevent cancer recurrence.
Participants will be randomly assigned to receive an active drug or a dummy treatment (placebo).
It's a Phase 3 trial, aiming to find better long-term treatments.
Regular visits and monitoring will be part of the study participation.

Who may be eligible?

To join this study, you must be a woman aged 18 or older (or 20 in some specific countries). You must have been recently diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer, and have already finished your first course of chemotherapy and surgery. It's important that your doctor believes you responded well to this first treatment, and that we can get a small sample of your tumor tissue for analysis.

There are also some reasons why you might not be able to join. For example, if you have certain types of ovarian cancer (like pure sarcomas or borderline tumors), or if you have another active cancer, or cancer that has spread to your brain. You also can't have had any other treatments for your ovarian cancer apart from your initial chemotherapy and surgery. We also need to make sure you don't have certain other health conditions, like severe lung disease or an active autoimmune disease that requires strong medication.

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 (or 20 in Japan, Taiwan, or South Korea)?
Have you been diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer?
Have you completed your first course of chemotherapy and surgery for this cancer?
Has your doctor told you that your cancer responded well to your initial treatment?
Do you have a tumor sample available for further analysis?
Do you have any other significant illnesses or active autoimmune diseases?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of four groups. This means you have an equal chance of receiving rucaparib, nivolumab, or one of two different dummy treatments (placebos). The rucaparib is a tablet you would take by mouth, and the nivolumab is given through an IV drip. Neither you nor your doctor will know which treatment you are receiving – this is called a 'double-blind' study and helps ensure the results are fair and accurate.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and to receive your study medication. These visits will help the study team monitor your health and how you're responding to the treatment. The total duration of your participation, including the treatment period and follow-up, will be explained in detail by the study team. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that could help prevent your cancer from returning or growing for longer. However, there's no guarantee the study treatment will work for you, and you might receive a dummy treatment. There are also potential risks involved, as all medications can have side effects. The study drugs, rucaparib and nivolumab, have known side effects that your doctor will discuss with you. These can range from mild to serious. The study team will monitor you closely for any side effects. You have the right to withdraw from the study at any time, for any reason, without this affecting your ongoing medical care.

Locations (238)

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

Arizona Oncology Associates, PC - HAL
Verified postcode
Phoenix, United States
Arizona Oncology Associates, PC - HOPE
Verified postcode
Tucson, United States
The University of Arizona Cancer Center
Verified postcode
Tucson, United States
John Muir Clinical Research Center
Verified postcode
Concord, United States
UCLA Women's Health Clinical Research Unit
Verified postcode
Los Angeles, United States
Kaiser Permanente Northern California
Verified postcode
San Francisco, United States
University of Colorado Cancer Center
Verified postcode
Aurora, United States
Rocky Mountain Cancer Centers
Verified postcode
Lakewood, United States
Yale University
Verified postcode
New Haven, United States
Florida Gynecologic Oncology
Verified postcode
Fort Myers, United States
MD Anderson Cancer Center-Baptist
Verified postcode
Jacksonville, United States
Baptist Health Medical Group Oncology, LLC
Verified postcode
Miami, United States

Common questions

What is 'maintenance treatment'?

Maintenance treatment is a treatment given after your initial cancer treatment has worked well, to try and keep the cancer from coming back or growing for as long as possible.

What does 'randomised, double-blind' mean?

This means you'll be put into a treatment group by chance (randomised), and neither you nor your doctor will know if you're getting the study drug or a dummy treatment (double-blind). This helps make the study results fair.

What's the difference between rucaparib and nivolumab?

Rucaparib is a tablet you take by mouth, and it works by interfering with how cancer cells repair themselves. Nivolumab is given through a drip and helps your body's immune system fight cancer.

Will I definitely get one of the study drugs?

No, because this is a comparative study, you have an equal chance of receiving one of the active study drugs or a placebo (a dummy treatment).

What happens if I decide I don't want to continue with the study?

You are free to leave the study at any time, for any reason. Your decision will not affect your relationship with your medical team or your standard care.