Active not recruitingPHASE3INTERVENTIONAL

Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer

This worldwide study is looking at a new treatment called Rina-S for ovarian cancer that has become resistant to platinum-based chemotherapy. Researchers want to see how well Rina-S works compared to other chemotherapy drugs that are already approved and commonly used for this type of cancer. If you join, you would have an equal, 50% chance of receiving either Rina-S or one of four standard chemotherapy medicines. Neither you nor your doctor would know which treatment you are getting until you start. Importantly, everyone in the study will receive an active drug, meaning no one will get a placebo (a dummy pill).

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Genmab

Enrolment target

530

Start

07 Feb 2025

Estimated completion

23 May 2028

Platinum-resistant Ovarian Cancer

What is this study about?

This study is for women with a type of ovarian cancer that has stopped responding to a common chemotherapy drug called platinum. When cancer becomes 'platinum-resistant,' it means the platinum-based treatments aren't working as well as they used to. This can be a challenging time, and doctors are always looking for new and better ways to help.

Researchers are investigating a new medication called Rina-S. They want to compare it directly with the chemotherapy treatments that doctors currently use for platinum-resistant ovarian cancer. By doing this, they hope to find out if Rina-S can be a new and effective option for patients.

Taking part in this study means you would receive either the new Rina-S treatment or one of the standard chemotherapy drugs. The choice of which treatment you receive will be made randomly, like flipping a coin. This is done to make sure the study results are fair and accurate. You won't know which treatment you're getting until it's time for your first dose. Rest assured, no one in this study will receive a placebo; everyone will be treated with an active medication.

Key takeaways

Tests a new drug (Rina-S) for platinum-resistant ovarian cancer.
Compares Rina-S to standard chemotherapy treatments.
50/50 chance of receiving Rina-S or a standard chemotherapy.
No placebo; all participants receive active medication.
Close medical monitoring throughout the study.
You can withdraw from the study at any time.

Who may be eligible?

This study is for women who have been diagnosed with certain types of ovarian cancer, including those affecting the fallopian tubes or the lining of the abdomen, specifically if it's high-grade serous or endometrioid. You must have already had between 1 and 4 previous chemotherapy treatments, and your cancer must have started growing again after your most recent treatment.

You also need to have tried platinum-based chemotherapy in the past. If your country's guidelines suggest it, you should also have had a treatment called bevacizumab, unless you can't take it for medical reasons. If you have BRCA gene changes and responded well to platinum chemotherapy, you should have also received a PARP inhibitor treatment, unless you can't take it.

Crucially, your cancer must now be considered 'platinum-resistant.' This means your cancer is no longer responding well to platinum-based chemotherapy. If you've only had one previous platinum-based treatment, you must have completed at least four cycles of it.

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 over?
Do you have high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer?
Has your cancer become platinum-resistant?
Have you had between 1 and 4 previous lines of cancer treatment?
Has your cancer started growing again after your last treatment?
Have you previously received platinum chemotherapy and usually bevacizumab (if available)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned either the new drug Rina-S or one of the standard chemotherapy treatments. You'll have regular hospital visits for your treatment, which will be given as injections or infusions. During these visits, the study team will monitor your health closely, perform physical exams, take blood and urine samples, and conduct scans to see how your body is responding to the treatment and to check for any side effects. The exact schedule will vary, but you can expect frequent check-ups, especially at the beginning.

You will continue treatment for as long as it is benefiting you and you are tolerating it well. After you finish the treatment part of the study, you'll have follow-up appointments to monitor your health over time. The total duration of your involvement could be many months or longer, depending on your individual response and the study's follow-up schedule.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. A potential benefit could be access to a new treatment (Rina-S) that isn't yet widely available, which might work better for your cancer than standard options. You'll also receive very close medical monitoring, which can be reassuring. However, there are risks involved. The new drug Rina-S might have side effects that are not fully known yet, or it might not work as well as expected. Standard chemotherapy also has known side effects, which can be unpleasant. You'll be fully informed about all known risks before you decide to join. Remember, taking part in this study is completely your choice, and you are free to withdraw at any time for any reason without it affecting your usual medical care.

Locations (177)

Alaska Women's Cancer Care
Verified postcode
Anchorage, United States
Arizona Center for Cancer Care (ACCC) - Biltmore
Verified postcode
Scottsdale, United States
University of Arizona Cancer Center - Research and Administration at Main Campus
Verified postcode
Tucson, United States
Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
Verified postcode
Burbank, United States
University of California San Diego Moores Cancer Center
Verified postcode
La Jolla, United States
USCF Mission Bay
Verified postcode
San Francisco, United States
Kaiser Permanente - Vallejo Medical Center
Verified postcode
Vallejo, United States
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
Verified postcode
Aurora, United States
Hartford Hospital
Verified postcode
Hartford, United States
Yale School of Medicine
Verified postcode
New Haven, United States
Norwalk Hospital
Verified postcode
Norwalk, United States
SCRI - Florida Cancer Specialists - South Region Research Office
Verified postcode
Fort Myers, United States

Common questions

What does 'platinum-resistant ovarian cancer' mean?

It means your ovarian cancer has stopped responding well to chemotherapy drugs that contain platinum. Your doctors are looking for other ways to treat it effectively.

Will I definitely get the new drug Rina-S?

No, there's a 50/50 chance. You could get Rina-S, or you could get one of the standard chemotherapy drugs already used for this type of ovarian cancer.

Will I receive a placebo in this study?

No, absolutely not. Everyone in this study will receive an active treatment, either Rina-S or a standard chemotherapy.

How long will I be in the study?

Treatment continues as long as it's helping you and you're tolerating it. After treatment, there are follow-up visits, so your total time in the study could be many months.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, for any reason, without it affecting your future medical care.