West Cancer Center

Ovarian: Non-HRD Positive: Maintenance: \"TroFuse-021/GOG-3102\"

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)

Title

Merck MK-2870-021 post-1st line maintenance Ovarian

Study Title

Site Link

NCT07318558

Malignancy

Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Stage

Stage 4

Disease Setting

Relapsed/Refractory

Line Of Therapy

Maintenance following 1st line

Investigational Agent

Sactizumab tirumotecan

Drug Class

ADC

Michael Ulm, MD

Sponsor

Merck Sharp and Dohme

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (>50%) Grade 3 features are present.
Has completed primary debulking surgery or interval debulking surgery.
Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.
No active CNS mets
No severe eye disease
No active IBD
No prior chemotherapy other than 1st line platinum-based regimen

Objective

Primary:
- PFS
Secondary
- OS
- PFS2
- Safety
- QoL

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Epithelial: either high-grade serous, high-grade endometrioid, clear cell, or maignant mixed Mullerian with high-grade serous component

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes