Clinical trial NCT04675320: Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors
Official title: Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Cancer
Keywords: PARP Inhibitors
immunomonitoring
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Cohort 1: Maintenance treatment of adult patients with newly diagnosed BRCA1/2-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) who have had a partial or complete response to first-line platinum-based chemotherapy. BRCA-mutated epithelial ovarian cancer - maintenance with Olaparib / Niraparib or Olaparib + bevacizumab
* Cohort 2: Single-agent maintenance treatment of adult patients with platinum-sensitive, recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer who are responding (complete or partial) to platinum-based chemotherapy. Recurrent epithelial ovarian cancer - maintenance with Niraparib or Olaparib

Brief summary: This study concerns the creation of a biological collection (blood samples) in patients with Epithelial Ovarian Cancer in in order to describe the immune response with PARP inhibitors.

Detailed description: The aim is to assess the impact of anti-PARP on peripheral immune populations and the amount of DNA circulating; to correlate these data with tumor infiltration, with the initial clinical characteristics and with the clinical course; compare the immunogenic effect of different anti-PARPs.

Eligibility criteria: Inclusion Criteria:

1. Patient over 18 years
2. Patient treated for epithelial ovarian cancer
3. Eligible for anti-PARP therapy and in one of the 2 cohorts below:

   * Cohort 1: Maintenance treatment of adult patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) with or without BRCA1/2 mutation, who have had a partial or complete response to first-line platinum-based chemotherapy.
   * 2nd cohort: single-agent maintenance treatment of adult patients with platinum-sensitive, recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer who have responded (completely or partially) to platinum-based chemotherapy.
4. Patient having signed the informed consent form.
5. Patient fit and able to comply with the protocol for the duration of the study, including visits, scheduled sampling and follow-up.
6. Patient affiliated to the social security system.

Exclusion Criteria:

1. Non-epithelial tumour of the ovary
2. Patient unable to understand, read and/or sign informed consent.
3. Current or previous use of immunosuppressive medication within 14 days prior to inclusion (except intranasal corticosteroids, systemic corticosteroids in physiological doses not exceeding 10 mg daily of prednisone or its equivalent, corticosteroids used as premedication for hypersensitivity reactions.
4. Patient participating in other research that may modify the systemic treatment administered in the cohort in which she will be included.
5. Pregnant or breast-feeding women.
6. HIV and/or HBV and/or HCV serology positive.
7. Patient refusal.
8. Person benefiting from a system of protection for adults (including guardianship, curatorship and safeguard of justice).
9. Inability to undergo medical follow-up for geographical, social or psychological reasons.

Primary outcomes:
measure: Immune response in plasma
timeFrame: From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months
measure: Immune response in PBMC
timeFrame: From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months
measure: Immune response in tumor DNA
timeFrame: From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU Jean Minjoz
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
Study officials:
References: