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Compares treatment options for Ovarian Cancer
Official title Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)
ClinicalTrials.gov ID: NCT06819007
What this study is testing
What is Trastuzumab Deruxtecan?
Trastuzumab Deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Also referred to as T-DXd, ENHERTU®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial is designed 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific...
- Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is...
- Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment...
- Is newly diagnosed FIGO Stage III or IV.
- Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing. \ For participants in the...
You likely can't join if
- Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
- Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.
- Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not...
- HRD negative
- HRD positive with SD as best response after platinum
- HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea
See the full eligibility criteria
- Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx...
- Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old.
- Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell...
- Is newly diagnosed FIGO Stage III or IV.
- Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing. \ For participants in the safety run-in phase, HER2 expression assessed by either local (require...
- Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination. \...
- Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.
- Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent...
- Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
- Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.
- Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows:
- HRD negative
- HRD positive with SD as best response after platinum
- HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea
- HRD tested, but inconclusive
- HRD positive but safety concern (safety concern to be specified).
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.
- Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization. \ Note: For participants enrolled from the Republic of Korea,
- Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
- Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.
- Evidence of active or ongoing bowel obstruction.
- Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV). Participants with troponin levels above the upper...
- Has a corrected QT interval prolongation to \>480 msec based on average of the Screening triplicate 12-lead ECG.
- Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Burbank, California, United States
- La Jolla, California, United States
- Palo Alto, California, United States
- Fort Lauderdale, Florida, United States
- Jupiter, Florida, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- Savannah, Georgia, United States
- Evanston, Illinois, United States
- Indianapolis, Indiana, United States
- Shreveport, Louisiana, United States
- Towson, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- Billings, Montana, United States
- Paramus, New Jersey, United States
- New York, New York, United States
+ 153 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Burbank, California, United States; La Jolla, California, United States; Palo Alto, California, United States; Fort Lauderdale, Florida, United States; Jupiter, Florida, United States; Miami Beach, Florida, United States and 167 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.