Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
AstraZeneca
Study ID
NCT06467357
Phase
PHASE3
Status
Recruiting
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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Standard of care chemotherapy by intravenous infusion
  • Cisplatin — DRUG
    Standard of care chemotherapy by intravenous infusion
  • Durvalumab — DRUG
    Standard of care immunotherapy by intravenous infusion
  • Trastuzumab deruxtecan — DRUG
    Experimental therapy by intravenous infusion
  • Rilvegostomig — DRUG
    Experimental therapy by intravenous infusion

Study Details

The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.

Key Dates

Start date
Aug 12, 2024
Status verified
May 2026
Primary completion
Jun 12, 2028
Completion
May 16, 2029

Study Design

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

Arms

  • Experimental: Trastuzumab deruxtecan + rilvegostomig
    Trastuzumab deruxtecan (T-DXd; DS-8201a) in combination with rilvegostomig arm
  • Experimental: Trastuzumab deruxtecan
    Trastuzumab deruxtecan (T-DXd; DS-8201a) arm
  • Active Comparator: Standard of Care
    Gemcitabine and cisplatin in combination with durvalumab arm

Primary Outcome Measure

Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig [ Time Frame: Until all patients have completed at least 1 full Cycle (each cycle is 21 days) ]

Central Contacts

Locations (48)

FacilityCityStateZIPSite coordinators
Research SiteScottsdaleArizona85259-
Research SiteTucsonArizona85704-
Research SiteTucsonArizona85719-
Research SiteFullertonCalifornia92835-
Research SiteLa JollaCalifornia92093-
Research SiteLos AlamitosCalifornia90720-
Research SiteLos AngelesCalifornia90017-
Research SiteLos AngelesCalifornia90089-
Research SiteSan FranciscoCalifornia94143-
Research SiteWalnut CreekCalifornia94598-
Research SiteWashington D.C.District of Columbia20007-
Research SiteFort MyersFlorida33901-
Research SiteJacksonvilleFlorida32224-
Research SiteSt. PetersburgFlorida33705-
Research SiteTampaFlorida33606-
Research SiteWest Palm BeachFlorida33401-
Research SiteAtlantaGeorgia30309-
Research SiteCoeur d'AleneIdaho83814-
Research SiteChicagoIllinois60612-
Research SiteNilesIllinois60714-
Research SiteTowsonMaryland21204-
Research SiteBostonMassachusetts02215-
Research SiteWorcesterMassachusetts01655-
Research SiteDetroitMichigan48202-
Research SiteGrand RapidsMichigan49503-
Research SiteRochesterMinnesota55905-
Research SiteKansas CityMissouri64132-
Research SiteSt LouisMissouri63110-
Research SiteAlbuquerqueNew Mexico87102-
Research SiteNew YorkNew York10032-
Research SiteWhite PlainsNew York10601-
Research SiteClevelandOhio44111-
Research SiteClevelandOhio44124-
Research SiteClevelandOhio44195-
Research SiteColumbusOhio43210-
Research SitePittsburghPennsylvania15232-
Research SiteGreenvilleSouth Carolina29605-
Research SiteNashvilleTennessee37203-
Research SiteAustinTexas78705-
Research SiteDallasTexas75246-
Research SiteFort WorthTexas76104-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77030-
Research SitePearlandTexas77584-
Research SiteSan AntonioTexas78217-
Research SiteSan AntonioTexas78258-
Research SiteFairfaxVirginia22031-
Research SiteFairfaxVirginia22031-

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