RecruitingPhase 2NCT07340164

Trastzumab Deruxtecan Versus SOC in Recurrent Ovarian That Progressed on Prior PARP Inhibitor Therapy

A Phase 2, Open-label, Multicenter, Randomized Study of Trastuzumab Deruxtecan Versus Investigator's Choice Chemotherapy in Recurrent Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy: TROY (APGOT-OV14)


Sponsor

Yonsei University

Enrollment

116 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Ovarian, fallopian tube, and peritoneal cancers are often diagnosed at an advanced stage, requiring chemotherapy. Recently, the standard treatment, platinum-based chemotherapy plus PARP inhibitors, has extended disease-free survival (PFS). However, most patients eventually develop resistance to PARP inhibitors and become unresponsive to conventional treatments. Therefore, an effective standard treatment for patients who relapse after PARP inhibitor resistance has not yet been established. Meanwhile, HER2 protein expression has been identified in some patients, drawing attention as a new therapeutic target. Trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate (ADC) targeting HER2, has already demonstrated efficacy and safety in other HER2-positive cancers. This study aimed to explore the potential of T-DXd as a new treatment option by evaluating the efficacy and safety of T-DXd in patients with ovarian, fallopian tube, and peritoneal cancer who relapsed after PARP inhibitor treatment and who express HER2. Participants will: * Arm A: T-DXd +/- Bevacizumab, IV, every 3weeks * Arm B: Platinum-based chemotherapy +/- Bevacizumab, IV


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bevacizumab, a drug called Platinum Based Chemotherapy, and others for people with ovarian cancer, ovarian cancer (ovca), and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastzumab Deruxtecan

Trastzumab deruxtecan will be administrated via intravenous, every 3 weeks.

DRUGBevacizumab

Bevacizumab is administered intravenously in one of two doses: 1. 10 mg/kg every 2 weeks 2. 15 mg/kg every 3 weeks 1. 10mg/kg, every 2weeks 2. 15mg/kg, every 3weeks

DRUGPlatinum Based Chemotherapy

\*Proposed regimens for Arm B 1. PLD 30\~40mg/m2 D1 + Carboplatin AUC 5 D1 +/- bevacizumab 10mg/kg D1/D15 q4w (for 6-8 cycles) followed by bevacizumab 15mg/kg q3w 2. Paclitaxel 175mg/m2 D1 + Carboplatin AUC 5 D1 +/- bevacizumab 15mg/kg D1 q3w (for 6-8 cycles) followed by bevacizumab 15mg/kg q3w 3. Gemcitabine 1000mg/m2 D1/D8 + Carboplatin AUC 4 or 5 D1 +/- bevacizumab 15mg/kg D1 q3w (for 6-8 cycles) followed by bevacizumab 15mg/kg q3w


Locations(1)

Yonsei University Health System, Severance Hospital

Seoul, Seoul, South Korea

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NCT07340164


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