Biomarker-driven Targeted Therapy in Patients With Recurrent Platinum-resistant Epithelial Ovarian Cancer

Sponsor
Tongji Hospital
Study ID
NCT05044871
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pamiparib — DRUG
    40mg PO. bid.
  • Bevacizumab — DRUG
    7.5mg/kg IV. D1 (q3w.)
  • Tislelizumab — DRUG
    200mg IV. D1
  • Nab paclitaxel — DRUG
    125mg / m2 IV. D1, 8 (q3w).
  • Bevacizumab + Nab paclitaxel (intense dose-dense) — DRUG
    Bevacizumab 7.5mg/kg IV. D1, 15 (Q4w). + Nab paclitaxel 100mg / m2 IV. D1, 8, 15 (Q4w).

Study Details

This study is an open-label, multicenter, umbrella study aimed to evaluate the combined, biomarker-driven, targeted treatment efficiency of Pamiparib, Bevacizumab, Tislelizumab, and Nab-paclitaxel in patients with platinum-resistant recurrent ovarian cancer (PROC).

Key Dates

First listed
Sep 16, 2021
Start date
Jul 22, 2022
Status verified
Jun 2025
Primary completion
Feb 17, 2025
Completion
Feb 17, 2025

Study Design

Enrollment
108 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Pamiparib+ Bevacizumab
    Arm1 (Biomarkers: BRCA 1/2 mutant): Pamiparib 40mg PO. bid. plus Bevacizumab 7.5mg/kg IV. D1 (q3w.).
  • Experimental: Arm 2: Tislelizumab + Bevacizumab + Nab-paclitaxel
    Arm2 (Biomarkers: BRCA 1/2 wildtype and ≥3 CD8+ TILs count): Tislelizumab 200mg IV. D1 + Bevacizumab 7.5mg/kg IV. D1 + Nab-paclitaxel 125mg / m2 IV. D1, 8 (q3w).
  • Experimental: Arm 3: Bevacizumab + Nab-paclitaxel
    Arm3 (Biomarkers: BRCA 1/2 wildtype and \<3 CD8+ TILs count): Bevacizumab 7.5mg/kg IV D1, 15 + Nab-paclitaxel 100mg / m2 IV D1, 8, 15 (Q4w).

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 3 years ]

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