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NCT03959761
NCT03959761
Who may be able to join
Who might be able to join this trial:
- You are at least 18 years old.
- You are able and willing to sign a consent form and follow the study schedule.
- You have been diagnosed (confirmed by lab testing) with ovarian cancer, peritoneal cancer, or fallopian tube cancer that has come back, including several specific types (confirm with trial site if unsure of your type).
- Your cancer has come back and surgery to remove it was not an option the first time it returned after platinum-based chemotherapy.
- Your doctors believe you are now a suitable candidate for surgery to remove as much cancer as possible, followed by a heated chemotherapy wash inside the abdomen (called HIPEC), after having had one or more rounds of chemotherapy.
- Your blood counts are at a healthy enough level — specifically, your white blood cells and platelets are above certain minimum values (confirm exact values with trial site).
- Your kidneys and liver are working well enough, based on blood test results (confirm exact values with trial site).
- You do not have any serious unstable health conditions such as a recent heart attack (within the last 6 months), uncontrolled high blood pressure, severe infection, uncontrolled mental health conditions, or other conditions that could be made worse by treatment.
- If you could become pregnant, you have had a negative pregnancy test within 7 days before starting the study.
- If you could become pregnant, you agree to use effective contraception throughout the treatment and for 5 months after your last dose of the study drug.
Who may not be able to join:
- Your ovarian cancer has not been treated before (first-time diagnosis, not a relapse).
- Your cancer has come back for the first time after platinum chemotherapy and surgery to remove it is already considered a straightforward option from the start.
- You have had breast cancer or any other cancer in the past 5 years, unless it was a minor skin cancer or a very early-stage cervical condition that was fully removed.
- You have previously had radiotherapy to any part of your abdomen or pelvis.
- You have active coronary artery disease (a condition affecting the blood supply to your heart).
- You have a known active hepatitis B or C infection, or are HIV positive, in a way that could affect your immune system.
- You have a known pre-existing autoimmune disease (a condition where your immune system attacks your own body).
- You have a serious lung condition that severely limits your breathing.
- You have a known allergy to carboplatin or cisplatin (types of chemotherapy).
- Your doctors estimate you have less than 3 months to live.
- Your cancer has spread outside the abdominal area in a way that means curative surgery would not be possible at any point during treatment.
- You have signs of a bowel blockage, tumours in a location that could cause a bowel perforation, or inflammatory bowel disease.
- Your general health and ability to carry out daily activities is very poor, based on a standard medical scale (ECOG score of 3 or 4) (confirm with trial site).
- You cannot have a small tube placed inside your abdomen (intraperitoneal catheter) for medical reasons.
- You have moderate or severe nerve damage causing numbness or tingling in your hands or feet (confirm level with trial site).
- You have a history of certain blood or bone marrow disorders (myelodysplastic syndrome or acute myeloid leukaemia).
- You have had major surgery within 4 weeks before starting the study, or have not yet fully recovered from recent surgery.
- You have previously had a bone marrow transplant from a donor.
- You have previously been treated with a type of immunotherapy called an anti-PD-1 drug (confirm with trial site if unsure).
- You are currently pregnant or breastfeeding.
- You are not able to give informed consent.
- You are under a legal protection order or guardianship arrangement.
- You do not wish to take part in the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 2
Sponsor
Hospices Civils de Lyon
Registry
clinicaltrials_gov
Start date
17 October 2019
Est. completion
3 October 2022
Where this trial is recruiting
🇫🇷 France
Primary endpoints
Safety profile of the Intraperitoneal (IP) nivolumab treatment
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.