Study Details

Open

Trial of Trastuzumab Deruxtecan with Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer

to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry [IHC] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

Age & Gender

18 years ~ 99 years
Female

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

If you take part in the study, you will be randomized to one of the two groups to receive either the combination of T-DXd with bevacixumab or bevaczumab alone. There will be a tissue prescreening period, a main screening period, and a treatment period (there will be tests and procedures); and a follow up period

In-person visits:
up to 50

Total length of participation:
up to 6 years

Looking for Specific Volunteers

Able to participate:

you have histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma
have HER2 expression
Have a local HRD or breast cncer gene test result available
4. has recived standard of care bevacizumab in combination with front line platinum-based chemotherapy
has adequate organ and bone marrow function within 14 days before randomization

Not eligible if:

have ovarain, fallopian tube, or peritoneal cancer of non-epithelial origin
Has a history of severe hypersentitivity reaction to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies
has a history of Nephrotic syndrome
You are pregnant or breastfeeding
Have a BRCA mutation as per local test

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Linda Van Le
Obstetrics and Gynecology - Gynecologic Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Ovarian)
Women's Health

IRB Number

25-0602

ClinicalTrials.gov

NCT06819007