Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

Recruiting Phase 2 Phase 3 Interventional Study
Ovarian Carcinosarcoma Endometrial Carcinosarcoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
138 (estimated)
Sponsor
ARCAGY/ GINECO GROUP · Other
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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 pati…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Progressive or recurrent uterine carcinosarcoma (Malignant Mixed Mullerian Tumor-MMMT). 2. The primary diagnosis must be histologically confirmed by pathological expert review of the initial tumor or biopsy at relapse. 3. Mandatory tumor samples: Availability of an archival F…
Contacts

Isabelle RAY-COQUARD, Professor

+33184852020

apailhe@arcagy.org

CONTACT

Bénédicte VOTAN

+33184852020

apailhe@arcagy.org

CONTACT