Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06109779
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

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

Interventions

  • Rilvegostomig — DRUG
    Rilvegostomig IV (intravenous) Q3W
  • Placebo — DRUG
    Placebo IV (intravenous) Q3W
  • Capecitabine — DRUG
    Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice
  • Gemcitabine/Cisplatin — DRUG
    Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle
  • S-1 [Tegafur/Oteracil/gimeracil] — DRUG
    S-1 \[Tegafur/Oteracil/gimeracil\] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles

Study Details

A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.

Key Dates

Start date
Dec 4, 2023
Status verified
Mar 2026
Primary completion
Jan 2, 2029
Completion
May 3, 2030

Study Design

Enrollment
757 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
  • Placebo Comparator: Arm B
    Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)

Primary Outcome Measure

Recurrence free survival (RFS) for Arm A vs. Arm B [ Time Frame: Approximately 5 years ]

Locations (22)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SitePhoenixArizona85054-
Research SiteLos AngelesCalifornia90089-
Research SiteOrangeCalifornia92868-
Research SiteStanfordCalifornia94305-
Research SiteAuroraColorado80045-
Research SiteLittletonColorado80129-
Research SiteWashington D.C.District of Columbia20007-
Research SiteJacksonvilleFlorida32224-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60637-
Research SiteIowa CityIowa52242-
Research SiteKansas CityKansas66160-
Research SiteLexingtonKentucky40506-
Research SiteNew OrleansLouisiana70121-
Research SiteGrand RapidsMichigan49503-
Research SiteRochesterMinnesota55905-
Research SiteSt LouisMissouri63110-
Research SiteCommackNew York11725-
Research SiteMineolaNew York11501-
Research SitePhiladelphiaPennsylvania19144-
Research SiteDallasTexas75246-

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By research site
Research Site· Birmingham, ALResearch Site· Phoenix, AZResearch Site· Los Angeles, CAResearch Site· Orange, CAResearch Site· Stanford, CAResearch Site· Aurora, CO

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