Recruiting
Phase 3

Rilvegostomig vs. Durvalumab

Sponsor:

AstraZeneca

Code:

NCT07221253

Conditions

Biliary Tract Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rilvegostomig

Durvalumab

Gemcitabine/Cisplatin

Study Details

Brief summary:

The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.

Conditions

Biliary Tract Cancer

Study ID

NCT07221253

Start date

Dec 4, 2025

Status verified date

Aug, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).
  • Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting
  • Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
  • Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
  • ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.
  • Adequate bone marrow and organ function.

Key exclusion Criteria:

  • Ampullary carcinoma
  • Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.
  • Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.
  • Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.
  • Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
  • Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.

Study Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control Arm

Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

experimental: Experimental Arm

Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

Interventions

Rilvegostomig

Rilvegostomig IV (intravenous) Q3W

Durvalumab

Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.

Gemcitabine/Cisplatin

Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

Primary outcome measure

  • Overall Survival (OS) in the PDL1 ≥ 1% population [ Time Frame: approximately 4 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Phoenix, Arizona, United States, 85054

Research Site

Recruiting

Tucson, Arizona, United States, 85719

Research Site

Recruiting

Duarte, California, United States, 91010

Research Site

Recruiting

Los Angeles, California, United States, 90095

Research Site

Recruiting

Orange, California, United States, 92868

Research Site

Recruiting

Palo Alto, California, United States, 94304

Research Site

Recruiting

Aurora, Colorado, United States, 80045

Research Site

Recruiting

New Haven, Connecticut, United States, 06510

Research Site

Recruiting

Washington D.C., District of Columbia, United States, 20007

Research Site

Recruiting

Gainesville, Florida, United States, 32610

Research Site

Recruiting

Jacksonville, Florida, United States, 32224

Research Site

Recruiting

Marietta, Georgia, United States, 30060

Research Site

Recruiting

Louisville, Kentucky, United States, 40217

Research Site

Recruiting

Baltimore, Maryland, United States, 21231

Research Site

Recruiting

Rochester, Minnesota, United States, 55905

Research Site

Recruiting

Santa Fe, New Mexico, United States, 87505

Research Site

Recruiting

New York, New York, United States, 10032

Research Site

Recruiting

Lancaster, Pennsylvania, United States, 17601

Research Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Research Site

Recruiting

Providence, Rhode Island, United States, 02903

Research Site

Recruiting

Pierre, South Dakota, United States, 57501

Research Site

Recruiting

Sioux Falls, South Dakota, United States, 57105

Research Site

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Research Site

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Research Site

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Research Site

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Research Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Research Site

Recruiting

Québec, Quebec, Canada, G1J 1Z4

More Information

Sponsor

AstraZeneca

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Rilvegostomig
  • Durvalumab
  • Biliary Tract Cancer
  • Bispecific Antibody
  • PD-L1
  • TIGIT
  • Initially Unresectable
  • Recurrent
  • Intra-hepatic cholangiocarcinoma
  • Extra-hepatic cholangiocarcinoma
  • Gallbladder cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-21.