Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors (IMMUNOPARP)

Centre Georges Francois Leclerc

Status: Active, not recruiting

Conditions: Ovarian Cancer

Treatments: Biological: blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT04675320

2020-A00036-33

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

First-line epithelial ovarian cancer (30 patients)

Description:

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.

Treatment:

Biological: blood samples

Recurrent epithelial ovarian cancer (20 patients)

Description:

Single-agent maintenance treatment of adult patients with primary, recurrent, platinum-sensitive epithelial ovarian, fallopian tube or peritoneal cancer who have responded (completely or partially) to platinum-based chemotherapy.

Treatment:

Biological: blood samples