All studies
Active not recruitingPHASE2INTERVENTIONAL

OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC

This study is for women with ovarian cancer that has come back but is still sensitive to platinum chemotherapy. It's looking for new ways to keep the cancer from returning quickly after chemotherapy. Participants will receive either a new vaccine called OSE2101, a combination of OSE2101 and Pembrolizumab (Keytruda), or standard supportive care. The aim is to see if the new treatments can prolong the time until the cancer progresses or returns. This research is important because there isn't a widely approved treatment to maintain remission in this specific situation, and it hopes to find better long-term options for patients.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
ARCAGY/ GINECO GROUP
Enrolment target
180
Start
05 Aug 2021
Estimated completion
01 Dec 2025

What is this study about?

This study is for women with ovarian cancer that has returned after initial treatment, but whose cancer still responds well to platinum-based chemotherapy. This type of cancer is called 'platinum-sensitive recurrent ovarian cancer'. Even after chemotherapy, there isn't a proven maintenance treatment that can reliably keep the cancer away for longer periods, especially after having received certain other medications like bevacizumab and PARP inhibitors. This means there's a real need for new approaches to help patients stay well for longer after their chemotherapy.

The researchers are testing a new vaccine called OSE2101. This vaccine is designed to help your body's immune system recognise and fight cancer cells. They believe that if the immune system can be made stronger to fight the cancer, it might delay the cancer from returning. The study will also look at combining this vaccine with another drug called Pembrolizumab (Keytruda), which is an immunotherapy that works to boost your immune system's ability to attack cancer. The idea is that these two treatments together might be even more effective.

Patients taking part in this study will be split into three groups by chance (like drawing names from a hat): one group will receive the OSE2101 vaccine, another group will receive the OSE2101 vaccine plus Pembrolizumab, and the third group will receive what is called Best Supportive Care. Best Supportive Care means you will receive the usual care to manage your symptoms and maintain your quality of life, without receiving the experimental drugs. The study will then compare these groups to see if the new treatments can help patients live longer without their cancer getting worse, helping to find better long-term options for women with this condition.

Key takeaways

  • This study is for women with recurrent ovarian cancer that previously responded to platinum chemotherapy.
  • It tests a new vaccine (OSE2101) alone or with an immunotherapy drug (Pembrolizumab) against standard supportive care.
  • The goal is to find better ways to keep the cancer from returning for longer.
  • You must have a specific genetic marker (HLA-A2) to be eligible.
  • Taking part means you might receive an experimental treatment or standard care, decided by chance.
  • Your suitability will be carefully checked by the study team.

Who may be eligible?

This study is for women aged 18 or over who have ovarian cancer that has returned but is still responsive to platinum-based chemotherapy. You must have a specific genetic marker called HLA-A2, which will be checked with a blood test. Your overall health and fitness should be good enough to take part.

You should have previously received chemotherapy for your returned cancer, and your cancer should have responded well to it (meaning it shrank, disappeared, or stayed stable). You should also have previously been treated with or considered for bevacizumab and/or a PARP inhibitor. Randomisation into the study will happen within 8 weeks of your last dose of chemotherapy.

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.

  1. Are you a woman aged 18 or older?
  2. Has your ovarian cancer come back, but responded well to platinum chemotherapy?
  3. Have you been treated with or considered for bevacizumab and/or a PARP inhibitor?
  4. Are you within 8 weeks of finishing your last dose of chemotherapy?
  5. Are you in generally good health, as assessed by your doctor?
  6. Are you willing to have a blood test to check for a specific genetic marker (HLA-A2)?
Answer every question to see your result.

What does participation involve?

If you join this study, your treatment will depend on which group you are assigned to. You will either receive the OSE2101 vaccine, the OSE2101 vaccine along with Pembrolizumab, or Best Supportive Care. The OSE2101 vaccine would be given as injections, initially every three weeks, then less often, up to two years. If you also receive Pembrolizumab, it would be given through a drip every six weeks, also for up to two years.

You will have regular check-ups, blood tests, and scans to monitor your health and how the treatment is working. This will continue until your cancer progresses, you can no longer tolerate the treatment, or for up to two years, whichever comes first. Even after stopping the treatments, there will be long-term follow-up to see how you are doing.

Potential risks and benefits

Through taking part, you might be among the first to benefit from a new treatment if it proves effective, potentially extending the time your cancer remains under control. However, new treatments can have side effects that are not yet fully known or understood, and the treatment might not work for everyone. The study treatments could cause unpleasant side effects, and your doctor will discuss these with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

  • UZ Leuven
    Verified postcode
    Leuven, Belgium
  • Centre Hospitalier de l'Ardenne Vivalia
    Verified postcode
    Libramont, Belgium
  • Centre Hospitalier Universitaire de Liège
    Verified postcode
    Liège, Belgium
  • ICO Paul Papin
    Verified postcode
    Angers, France
  • Institut du Cancer Avignon-Provence
    Verified postcode
    Avignon, France
  • Centre Hospitalier de la Côte Basque
    Verified postcode
    Bayonne, France
  • CHU Besançon - Hôpital Jean Minjoz
    Verified postcode
    Besançon, France
  • Institut Bergonié
    Verified postcode
    Bordeaux, France
  • Centre François Baclesse
    Verified postcode
    Caen, France
  • Centre d'Oncologie et de Radiothérapie 37
    Verified postcode
    Chambray-lès-Tours, France
  • Centre Hospitalier de Cholet
    Verified postcode
    Cholet, France
  • Centre Jean PERRIN
    Verified postcode
    Clermont-Ferrand, France

Common questions

What is 'platinum-sensitive ovarian cancer'?

This means your ovarian cancer responded well to previous chemotherapy drugs that contained platinum, like carboplatin. Even if it came back, it still shows it can be controlled by these types of drugs.

What is OSE2101?

OSE2101 is a new type of vaccine designed to stimulate your immune system to recognise and fight specific parts of ovarian cancer cells.

What is Pembrolizumab (Keytruda)?

Pembrolizumab is an immunotherapy drug that helps your body's immune system to work harder against cancer cells by 'releasing the brakes' on certain immune cells.

What does a 'maintenance treatment' mean?

Maintenance treatment is given after your main chemotherapy has finished and the cancer is under control. The aim is to keep the cancer from returning or growing for as long as possible.

Will I definitely get one of the new treatments?

Not necessarily. Patients are randomly assigned to one of three groups: OSE2101 alone, OSE2101 plus Pembrolizumab, or Best Supportive Care (which is the usual care without the experimental drugs).

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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