Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT03959761
Eligibility Criteria:
Inclusion Criteria:
* Patients at least 18 years of age.
* Signed informed consent and ability to comply with treatment and follow-up.
* Histological or cytological proven primary epithelial ovarian carcinoma or peritoneal cancer or fallopian tube carcinoma in relapse, including serous papillary adenocarcinoma, mucinous adenocarcinoma, clear-cell carcinoma, undifferentiated carcinoma, mixed mullerian tumor and endometrioid adenocarcinoma. Patients with low grade tumors can be included.
* Not eligible for front-line cytoreduction in first platinum-sensitive relapse
* Eligible for surgical cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) after one or more lines of chemotherapy. All chemotherapy regimens usually recommended for the treatment of ovarian cancer are accepted :
* Platinum based regimens +/- bevacizumab for the treatment of platinum sensitive disease.
* Non - platinum based regimens +/- bevacizumab for the treatment of platinum resistant disease.
* Satisfactory haematological evaluation: neutrophil rate greater than 1500/millimeters cubed, platelet count greater than 100 grams/liter;
* Satisfactory renal and hepatic function: serum creatinine ≤1.5 times the normal upper values or creatinine clearance ≥50 milliliters/minute, bilirubin ≤1.25 times upper normal values, ratio aspartate transaminase/alanine transaminase (AST/ALT) ≤1.5 times the upper normal values (≤5 times the upper normal values for patients with liver metastases)
* No unstable conditions: myocardial infarction within 6 months prior to the start of the study, congestive heart failure, unstable angina, active cardiomyopathy, unstable rhythm disorder, uncontrolled hypertension, uncontrolled psychiatric disorders, severe infection, peptic ulcer or any condition that could be aggravated by treatment or limit compliance (investigator assessment)
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the start of study drug.
* Women of childbearing potential should use an adequate method of contraception to avoid pregnancy during nivolumab treatment until 5 months after the last dose of investigational drug.
Exclusion Criteria:
* Ovarian cancer in first-line
* First platinum sensitive relapse amenable to initial cytoreduction surgery
* History of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
* Patients with active coronary artery disease
* Patients with known acute hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive, that might affect host immunity
* Patients with known pre-existent auto-immune disease
* Patients with severe restrictive or obstructive pulmonary disease
* Known carboplatin or cisplatin allergy
* Life expectancy less than 3 months
* Extraperitoneal metastases for which the site or number preclude potentially curative surgery at any moment during the course of the disease
* Sign of bowel obstruction or lesions whose topography indicates a risk of intestinal perforation or inflammatory bowel disease
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 3-4
* Contraindication to the placement of an intraperitoneal catheter
* peripheral sensory neuropathy grade at least 2
* Patient with myelodysplastic syndrome/acute myeloid leukemia history.
* Major surgery within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery.
* Previous allogenic bone marrow transplant
* Any previous treatment with Anti programmed cell death 1 (PD-1) immunotherapy
* Pregnant or lactating women
* Unable to give consent
* Patient under legal protection measures
* Refusal to participate in the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03959761
Study Brief:
Protocol Section:
NCT03959761