Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

ConditionsOvarian Carcinosarcoma Endometrial Carcinosarcoma

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexFemale

Age18+

SponsorARCAGY/ GINECO GROUP

About this trial

Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) \< 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is \<20%, progression-free survival (PFS) \<4 months, and OS \<1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.

Eligibility criteria

Qualifiers

Progressive or recurrent uterine carcinosarcoma (Malignant Mixed Mullerian Tumor-MMMT).

The primary diagnosis must be histologically confirmed by pathological expert review of the initial tumor or biopsy at relapse.

Mandatory tumor samples: Availability of an archival FFPE tumor sample(s) from diagnosis, or if not available from relapse setting.

Progressive disease as defined by RECIST 1.1.

Disqualifiers

Not enrolled in any interventional clinical trial (except to biological trials that must be validated by the sponsor)

Prior treatment with niraparib or other PARPi therapy or PD1/PDL-1 inhibitors.

Patient has had investigational therapy, immunotherapy, chemotherapy or biological therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to treatment initiation. Patient has had radiotherapy within 4 weeks prior to treatment initiation.

Patients must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects