Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This study is looking into an experimental vaccine called CryptiVax-1001 for advanced ovarian cancer, which includes cancers of the fallopian tube and primary peritoneum. The main goal is to check if this vaccine is safe for patients with a specific type called high-grade serous ovarian cancer. Doctors also want to learn if it can activate the body's immune system to fight the cancer. After surgery and chemotherapy, participants might receive CryptiVax-1001 to see if it helps keep the cancer from returning. This is a very early stage of testing, so understanding safety is the top priority. The study will gradually increase the vaccine dose to find the best amount for future trials.
At a glance
What is this study about?
Ovarian cancer, along with cancers of the fallopian tube and primary peritoneum, can be very serious. The most common and aggressive type is called high-grade serous ovarian cancer. Even after surgery and chemotherapy, there's a chance the cancer could come back, and doctors are always looking for new ways to prevent this.
This study is trying out a new and experimental vaccine called CryptiVax-1001. Think of it like a training exercise for your immune system. The idea is that if your immune system learns to recognise and fight cancer cells, it might be able to keep the cancer from returning or slow its growth. However, because this is the very first time this vaccine is being given to people, the main focus of this study is to make sure it's safe and to understand any side effects.
Patients who have had surgery and chemotherapy for their advanced high-grade serous ovarian cancer might be able to join this study. If they do, they would receive CryptiVax-1001 as an additional treatment after their standard care. Researchers will carefully watch how patients react to the vaccine, check their immune system's response, and slowly increase the dose to find the safest and most effective amount for future studies.
Key takeaways
- This is an early-stage (Phase 1) study for a new experimental cancer vaccine.
- The main goal is to check the safety of CryptiVax-1001 in advanced ovarian cancer patients.
- It's for patients who have finished surgery and chemotherapy, aiming to prevent cancer recurrence.
- Participation contributes to understanding potential new treatments for ovarian cancer.
- Specific eligibility rules apply, including cancer type and treatment history.
Who may be eligible?
To join this study, you need to be a woman aged 18 or older with a confirmed diagnosis of advanced high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. You must have already had surgery to remove as much of the cancer as possible and completed your first round of platinum-based chemotherapy. Importantly, the cancer should not have grown or spread between finishing chemotherapy and starting the study.
There are also specific requirements about your cancer's genetic makeup, known as BRCAwt status and HRP confirmation, and you shouldn't have received certain other maintenance treatments like bevacizumab or PARP inhibitors. Your general health, including your blood tests and organ function, needs to be good, and you should be able to move around and carry out daily activities without too much difficulty.
Some things that would prevent you from joining include having uncontrolled fluid build-up (ascites or pleural effusion), another cancer diagnosis in the last three years (unless it's a very low-risk type), active autoimmune diseases requiring medication, or if you are pregnant. Your doctors will check all these details very carefully to make sure the study is right and safe 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 female and 18 years or older?
- Do you have advanced high-grade serous ovarian, fallopian tube, or primary peritoneal cancer?
- Have you completed surgery and your first round of platinum-based chemotherapy?
- Has your cancer not progressed or returned since finishing chemotherapy?
- Are you generally well and able to perform daily activities with ease?
- Are you not pregnant?
What does participation involve?
If you decide to take part, you would receive the CryptiVax-1001 vaccine. This isn't a cure, but it's being tested as a way to keep your cancer from coming back after your initial treatment. The visits will involve regular check-ups, blood tests, and probably scans to see how your body is reacting to the vaccine and if the cancer remains stable. As this is a dose-finding study, you might start on a lower dose, and if it's safe, the dose may be increased for others in the study. The exact number of visits and the full duration of your participation will be explained in detail by the study team, but it will involve regular contact and monitoring over a period of time after your chemotherapy to assess the vaccine's effects.
Potential risks and benefits
Locations (10)
- Cambridge University Hospitals NHS Foundation Trust - Addenbrookes HospitalVerified postcodeCambridge, United Kingdom· Recruiting
- The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research CentreVerified postcodeEdinburgh, United Kingdom· Not yet recruiting
- Beatson West of Scotland Cancer CentreVerified postcodeGlasgow, United Kingdom· Not yet recruiting
- St. James's University HospitalVerified postcodeLeeds, United Kingdom· Not yet recruiting
- University Hospitals of Leicester NHS Trust -Leicester Royal InfirmaryVerified postcodeLeicester, United Kingdom· Recruiting
- University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials UnitVerified postcodeLondon, United Kingdom· Recruiting
- Guy's and St Thomas' NHS Foundation Trust - Guy's HospitalVerified postcodeLondon, United Kingdom· Not yet recruiting
- Royal Marsden NHS Foundation Trust - Royal Marsden HospitalVerified postcodeLondon, United Kingdom· Recruiting
- Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston HospitalVerified postcodePreston, United Kingdom· Not yet recruiting
- Royal Marsden NHS Foundation Trust - Institute of Cancer ResearchVerified postcodeSutton, United Kingdom· Recruiting
Common questions
What is CryptiVax-1001?
It's an experimental vaccine designed to teach your immune system to fight against ovarian cancer cells.
Is this vaccine a proven treatment?
No, it's an experimental treatment, meaning it's still in the early stages of testing to find out if it's safe and how it works.
Why is this study important?
It aims to find new ways to stop advanced ovarian cancer from coming back, especially for common types that don't have many existing maintenance options.
Who can join this study?
Women who have advanced ovarian, fallopian tube, or primary peritoneal cancer, and have completed surgery and chemotherapy, meeting specific health and cancer criteria.
What is 'maintenance therapy'?
It’s treatment given after initial cancer treatment to help keep the cancer from returning or growing, even if there are no signs of it currently.
How to find out more
Head of Development Operations
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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