Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Trastuzumab Deruxtecan for Ovarian Cancer

This clinical trial is designed to measure the how well it works and safety of T-DXd in combination with bevacizumab versus bevacizumab this drug alone 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.

Official registry: https://clinicaltrials.gov/study/NCT06819007 · Daiichi Sankyo · enrollment listed as 582

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Trastuzumab Deruxtecan, or Bevacizumab. The registry lists allocation as randomized. This clinical trial is designed to measure the how well it works and safety of T-DXd in combination with bevacizumab versus bevacizumab this drug alone 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.

They plan to enroll about 582 people at 232 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144-O/GOG-3112/APGOT-OV13)

Interventions: Trastuzumab Deruxtecan, Bevacizumab

Primary outcome (registry wording): Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ Population

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Women only
  • \*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures
  • 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, carcinosarcoma, mucinous)
  • Is newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV
  • Has HER2 expression

Public study contact (from the registry)

Contact for Trial Information

908-992-6400

CTRinfo_us@daiichisankyo.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

232 listed

+ 199 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06819007 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06819007?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06819007?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary