DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT06989112
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    Experimental therapy by intravenous infusion
  • Rilvegostomig — DRUG
    Experimental therapy by intravenous infusion
  • Pembrolizumab — DRUG
    Immunotherapy by intravenous infusion
  • Carboplatin — DRUG
    Standard of Care (SoC) chemotherapy by intravenous infusion
  • Paclitaxel — DRUG
    Standard of Care (SoC) chemotherapy by intravenous infusion
  • Docetaxel — DRUG
    Standard of Care (SoC) chemotherapy by intravenous infusion

Study Details

DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.

Key Dates

Start date
Mar 27, 2025
Status verified
May 2026
Primary completion
Jan 19, 2029
Completion
Feb 19, 2031

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: T-DXd + Rilvegostomig
    T-DXd IV Q3W plus rilvegostomig IV Q3W. Treatment will continue until objective disease progression according to RECIST v1.1 as assessed by the Investigator and confirmed by BICR or until other discontinuation criteria is met, whichever occurs first.
  • Experimental: Arm B: T-DXd + Pembrolizumab
    T-DXd IV Q3W plus pembrolizumab IV Q3W. Treatment will continue until objective disease progression according to RECIST v1.1 as assessed by the Investigator and confirmed by BICR or until other discontinuation criteria is met, whichever occurs first.
  • Active Comparator: Arm C: Carboplatin + Paclitaxel + Pembrolizumab
    Carboplatin, paclitaxel and pembrolizumab administered Q3W during 6 cycles, followed by maintenance with pembrolizumab IV Q6W during 14 cycles. Treatment with pembrolizumab will continue for up to 20 total cycles (approximately 24 months, accounting for combination and maintenance phases) or until other discontinuation criteria is met, whichever occurs first. At the discretion of the investigator, participants may continue to receive carboplatin, paclitaxel and pembrolizumab Q3W for up to 10 cycles. Docetaxel can be used as an alternative to paclitaxel for participants who had a hypersensitivity reaction to paclitaxel with a failed rechallenge (or not amenable to rechallenge), according to the investigator's clinical judgment.

Primary Outcome Measure

Progression-free survival (PFS), as assessed by BICR [ Time Frame: Until progression or death due to any cause (assessed up to approximately 45 months). ]

Central Contacts

Locations (60)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85704-
Research SiteLittle RockArkansas72205-
Research SiteDuarteCalifornia91010-
Research SiteIrvineCalifornia92618-
Research SiteLa JollaCalifornia92037-
Research SitePalo AltoCalifornia94304-
Research SiteSan FranciscoCalifornia94143-
Research SiteSylmarCalifornia91342-
Research SiteFort MyersFlorida33901-
Research SiteMiami BeachFlorida33140-
Research SiteOrlandoFlorida32804-
Research SiteSt. PetersburgFlorida33705-
Research SiteTampaFlorida33612-
Research SiteWest Palm BeachFlorida33401-
Research SiteAugustaGeorgia30912-
Research SiteHonoluluHawaii96813-
Research SiteArlington HeightsIllinois60005-
Research SiteEvanstonIllinois60201-
Research SiteShreveportLouisiana71103-
Research SiteBaltimoreMaryland21201-
Research SiteBostonMassachusetts02111-
Research SiteWorcesterMassachusetts01655-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48201-
Research SiteMinneapolisMinnesota55455-
Research SiteRochesterMinnesota55905-
Research SiteJacksonMississippi39216-
Research SiteSpringfieldMissouri65804-
Research SiteSt LouisMissouri63141-
Research SiteLas VegasNevada89169-
Research SiteLebanonNew Hampshire03756-
Research SiteHackensackNew Jersey07601-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10065-
Research SiteNew YorkNew York10075-
Research SiteCharlotteNorth Carolina28204-
Research SiteCharlotteNorth Carolina28204-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteCincinnatiOhio45220-
Research SiteColumbusOhio43210-
Research SiteOklahoma CityOklahoma73104-
Research SiteTulsaOklahoma74134-
Research SiteEugeneOregon97401-
Research SiteAbingtonPennsylvania19001-
Research SiteHersheyPennsylvania17033-
Research SitePhiladelphiaPennsylvania19111-
Research SitePittsburghPennsylvania15224-
Research SiteProvidenceRhode Island02905-
Research SiteCharlestonSouth Carolina29425-
Research SiteSioux FallsSouth Dakota57105-
Research SiteAustinTexas78758-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78240-
Research SiteCharlottesvilleVirginia22908-
Research SiteFairfaxVirginia22031-
Research SiteSeattleWashington98133-
Research SiteMadisonWisconsin53792-

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