A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
AstraZeneca
Study ID
NCT06764875
Phase
PHASE3
Status
Recruiting
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Conditions

  • Gastroesophageal Junction Adenocarcinoma
  • HER2-positive Gastric Cancer

Eligibility Criteria

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

Interventions

  • Rilvegostomig — DRUG
    Q3W, intravenous infusion
  • Trastuzumab deruxtecan — DRUG
    Q3W, intravenous infusion
  • Trastuzumab — DRUG
    Q3W, intravenous infusion
  • Pembrolizumab — DRUG
    Q3W, intravenous infusion
  • 5-fluorouracil — DRUG
    Q3W, intravenous infusion
  • Capecitabine — DRUG
    BID, oral administration
  • Cisplatin — DRUG
    Q3W, intravenous infusion
  • Oxaliplatin — DRUG
    Q3W, intravenous infusion

Study Details

This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

Key Dates

Start date
Mar 1, 2025
Status verified
May 2026
Primary completion
Apr 27, 2029
Completion
Dec 9, 2030

Study Design

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

Arms

  • Experimental: Arm A
    T-DXd + Rilvegostomig + Fluoropyrimidine (Capecitabine OR 5-FU)
  • Active Comparator: Arm B
    Pembrolizumab + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)
  • Active Comparator: Arm C
    Rilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: Up to approximately 6 years ]

Central Contacts

Locations (53)

FacilityCityStateZIPSite coordinators
Research SiteAnchorageAlaska99508-
Research SitePhoenixArizona85054-
Research SiteDuarteCalifornia91010-
Research SiteLa JollaCalifornia92037-
Research SiteLos AlamitosCalifornia90720-
Research SiteLos AngelesCalifornia90089-
Research SiteSanta MonicaCalifornia90404-
Research SiteSolvangCalifornia93463-
Research SiteUplandCalifornia91786-
Research SiteWalnut CreekCalifornia94598-
Research SiteAuroraColorado80045-
Research SiteNewarkDelaware19713-
Research SiteJacksonvilleFlorida32207-
Research SiteJacksonvilleFlorida32224-
Research SiteOrlandoFlorida32806-
Research SiteAthensGeorgia30607-
Research SiteMariettaGeorgia30060-
Research SiteChicagoIllinois60612-
Research SiteChicagoIllinois60637-
Research SiteEvanstonIllinois60201-
Research SiteHinsdaleIllinois60521-
Research SiteNilesIllinois60714-
Research SiteDyerIndiana46311-
Research SiteWaukeeIowa50263-
Research SiteLouisvilleKentucky40217-
Research SiteSilver SpringMaryland20904-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02118-
Research SiteDetroitMichigan48202-
Research SiteGrand RapidsMichigan49503-
Research SiteBurnsvilleMinnesota55337-
Research SiteKansas CityMissouri64111-
Research SiteSt LouisMissouri63108-
Research SiteOmahaNebraska68198-5885-
Research SiteRenoNevada89502-
Research SiteSummitNew Jersey07901-
Research SiteSanta FeNew Mexico87505-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10021-
Research SiteCincinnatiOhio45220-
Research SiteColumbusOhio43210-
Research SitePhiladelphiaPennsylvania19104-
Research SiteKnoxvilleTennessee37909-
Research SiteNashvilleTennessee37232-
Research SiteDallasTexas75246-
Research SiteRound RockTexas78665-
Research SiteWebsterTexas77598-
Research SiteCharlottesvilleVirginia22908-
Research SiteFairfaxVirginia22031-
Research SiteFairfaxVirginia22031-
Research SiteRichmondVirginia23235-
Research SiteCharlestonWest Virginia25304-
Research SiteMadisonWisconsin53792-

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