Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

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 us

Trial Details

NCT ID
NCT03651206
Phase
PHASE2 / PHASE3
Sponsor
ARCAGY/ GINECO GROUP
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Niraparib
  • Niraparib + TSR-042 (Dostarlimab)
  • Chemotherapy Drugs
Locations (sample)
  • Angers, France|47.47156,-0.55202
  • Besançon, France|47.24878,6.01815
  • Bordeaux, France|44.84124,-0.58046
  • Brest, France|48.39029,-4.48628
  • Caen, France|49.18585,-0.35912

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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