A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumours

Titre officiel

A Phase II, Open-Label, Multicentre, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumours

Sommaire:

This study will evaluate the efficacy and safety of multiple biomarker-driven treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumours. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

Description de l'essai

Primary Outcome:

  • Confirmed Objective Response Rate (ORR)
Secondary Outcome:
  • Duration of Response (DOR)
  • Disease Contral Rate (DCR)
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Confirmed ORR as Determined by IRC (Independent Review Committee)
  • DOR as Determined by IRC
  • DCR as Determined by IRC
  • PFS as Determined by IRC
  • Percentage of Participants With Adverse Events
  • Percentage of Participants With ADA-Positive and ADA-Negative to Atezolizumab
  • Number of Participants With ADA-Positive and ADA-Negative to Atezolizumab

Voir cet essai sur ClinicalTrials.gov

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