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New drug combo aims to extend life in bile duct cancer

NCT ID NCT07221253

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This global Phase 3 trial is testing whether adding the experimental immunotherapy rilvegostomig to standard chemotherapy helps people with advanced biliary tract cancer live longer, compared to adding the approved drug durvalumab. About 1,100 participants with inoperable or metastatic cancer will receive one of the two combinations. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rilvegostomig (AZD2936) and durvalumab (IMFINZI), both given with chemotherapy (gemcitabine/cisplatin)
What this could lead to
If successful, this could provide a new first-line treatment option that extends survival for people with advanced biliary tract cancer.
What could go wrong
This is an early-stage Phase 3 trial, so results are not guaranteed. Adding immunotherapy to chemo may increase side effects, and the benefit over current treatments may be modest or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms extrahepatic bile duct carcinoma gallbladder carcinoma gallbladder neoplasm intrahepatic cholangiocarcinoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    170 sites in 19 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35205, United States

  • Research Site

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Research Site

    RECRUITING

    Tucson, Arizona, 85719, United States

  • Research Site

    RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • Research Site

    RECRUITING

    Orange, California, 92868, United States

  • Research Site

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    Palo Alto, California, 94304, United States

  • Research Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Research Site

    NOT_YET_RECRUITING

    Hartford, Connecticut, 06102, United States

  • Research Site

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Research Site

    RECRUITING

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

  • Research Site

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20037, United States

  • Research Site

    RECRUITING

    Gainesville, Florida, 32610, United States

  • Research Site

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Research Site

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Research Site

    NOT_YET_RECRUITING

    Chicago, Illinois, 60612, United States

  • Research Site

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • Research Site

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Research Site

    RECRUITING

    Louisville, Kentucky, 40217, United States

  • Research Site

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40241, United States

  • Research Site

    RECRUITING

    Baltimore, Maryland, 21231, United States

  • Research Site

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    NOT_YET_RECRUITING

    Detroit, Michigan, 48202, United States

  • Research Site

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Research Site

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68198-5885, United States

  • Research Site

    RECRUITING

    Santa Fe, New Mexico, 87505, United States

  • Research Site

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Research Site

    RECRUITING

    New York, New York, 10032, United States

  • Research Site

    WITHDRAWN

    New York, New York, 10065, United States

  • Research Site

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Research Site

    RECRUITING

    Lancaster, Pennsylvania, 17601, United States

  • Research Site

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Research Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Research Site

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Research Site

    RECRUITING

    Pierre, South Dakota, 57501, United States

  • Research Site

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Research Site

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    NOT_YET_RECRUITING

    Clayton, 3168, Australia

  • Research Site

    RECRUITING

    Darlinghurst, 2010, Australia

  • Research Site

    RECRUITING

    Gosford, 2250, Australia

  • Research Site

    RECRUITING

    Murdoch, 6150, Australia

  • Research Site

    RECRUITING

    Anderlecht, 1070, Belgium

  • Research Site

    RECRUITING

    Edegem, 2650, Belgium

  • Research Site

    RECRUITING

    Leuven, 3000, Belgium

  • Research Site

    RECRUITING

    Liège, 4000, Belgium

  • Research Site

    RECRUITING

    Roeselare, 8800, Belgium

  • Research Site

    RECRUITING

    Barretos, 14784-400, Brazil

  • Research Site

    RECRUITING

    Natal, 59075-740, Brazil

  • Research Site

    RECRUITING

    Porto Alegre, 91350-200, Brazil

  • Research Site

    RECRUITING

    Ribeirão Preto, 14026-040, Brazil

  • Research Site

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Research Site

    RECRUITING

    Vitória, 29043-272, Brazil

  • Research Site

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • Research Site

    NOT_YET_RECRUITING

    Vancouver, British Columbia, VSZ 4E6, Canada

  • Research Site

    RECRUITING

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Research Site

    RECRUITING

    Barrie, Ontario, L4M 6M2, Canada

  • Research Site

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Research Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • Research Site

    RECRUITING

    Beijing, 100020, China

  • Research Site

    RECRUITING

    Beijing, 102218, China

  • Research Site

    RECRUITING

    Changchun, 130021, China

  • Research Site

    RECRUITING

    Changde, 415000, China

  • Research Site

    RECRUITING

    Changsha, 410005, China

  • Research Site

    WITHDRAWN

    Changsha, 410013, China

  • Research Site

    RECRUITING

    Chengdu, 610078, China

  • Research Site

    RECRUITING

    Fuzhou, 350005, China

  • Research Site

    RECRUITING

    Guangzhou, 510515, China

  • Research Site

    RECRUITING

    Hangzhou, 310022, China

  • Research Site

    RECRUITING

    Hefei, 230001, China

  • Research Site

    RECRUITING

    Kunming, 650101, China

  • Research Site

    WITHDRAWN

    Lishui, 323000, China

  • Research Site

    WITHDRAWN

    Luoyang, 471023, China

  • Research Site

    RECRUITING

    Nanchang, 330000, China

  • Research Site

    RECRUITING

    Nanning, 530000, China

  • Research Site

    RECRUITING

    Shandong, China

  • Research Site

    RECRUITING

    Shanghai, 200032, China

  • Research Site

    RECRUITING

    Shenyang, 110016, China

  • Research Site

    RECRUITING

    Weifang, 261000, China

  • Research Site

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    Wuhan, 430030, China

  • Research Site

    RECRUITING

    Xi'an, 710061, China

  • Research Site

    RECRUITING

    Clichy, 92118, France

  • Research Site

    RECRUITING

    Grenoble, 38043, France

  • Research Site

    RECRUITING

    Marseille, 13385, France

  • Research Site

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

  • Research Site

    RECRUITING

    Aachen, 52074, Germany

  • Research Site

    NOT_YET_RECRUITING

    Berlin, 10365, Germany

  • Research Site

    RECRUITING

    Berlin, 13353, Germany

  • Research Site

    RECRUITING

    Bonn, 53127, Germany

  • Research Site

    RECRUITING

    Düsseldorf, 40225, Germany

  • Research Site

    NOT_YET_RECRUITING

    Essen, 45122, Germany

  • Research Site

    RECRUITING

    Frankfurt, 60488, Germany

  • Research Site

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Research Site

    NOT_YET_RECRUITING

    Hamburg, 20249, Germany

  • Research Site

    RECRUITING

    Hamburg, 22763, Germany

  • Research Site

    RECRUITING

    Heidelberg, 69120, Germany

  • Research Site

    RECRUITING

    Heilbronn, 74078, Germany

  • Research Site

    RECRUITING

    Karlsruhe, 76133, Germany

  • Research Site

    NOT_YET_RECRUITING

    Magdeburg, 39120, Germany

  • Research Site

    RECRUITING

    München, 81675, Germany

  • Research Site

    NOT_YET_RECRUITING

    München, 81737, Germany

  • Research Site

    RECRUITING

    Ulm, 89081, Germany

  • Research Site

    NOT_YET_RECRUITING

    Delhi, 110029, India

  • Research Site

    NOT_YET_RECRUITING

    Hyderabad, 500032, India

  • Research Site

    WITHDRAWN

    Kolhāpur, 416234, India

  • Research Site

    RECRUITING

    Kolkata, 700063, India

  • Research Site

    NOT_YET_RECRUITING

    Kolkata, 700160, India

  • Research Site

    NOT_YET_RECRUITING

    Mumbai, 400012, India

  • Research Site

    NOT_YET_RECRUITING

    Nashik, 422002, India

  • Research Site

    RECRUITING

    Surat, 395002, India

  • Research Site

    RECRUITING

    Castellana Grotte, 70013, Italy

  • Research Site

    RECRUITING

    Milan, 20132, Italy

  • Research Site

    RECRUITING

    Pisa, 56126, Italy

  • Research Site

    RECRUITING

    Rome, 00168, Italy

  • Research Site

    RECRUITING

    Rozzano, 20089, Italy

  • Research Site

    RECRUITING

    Chiba, 260-8717, Japan

  • Research Site

    RECRUITING

    Kashiwa, 227-8577, Japan

  • Research Site

    RECRUITING

    Kawasaki-shi, 216-8511, Japan

  • Research Site

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Research Site

    RECRUITING

    Matsuyama, 790-0024, Japan

  • Research Site

    RECRUITING

    Nagoya, 464-8681, Japan

  • Research Site

    RECRUITING

    Nagoya, 466-8560, Japan

  • Research Site

    RECRUITING

    Osaka, 541-8567, Japan

  • Research Site

    RECRUITING

    Suita-shi, 565-0871, Japan

  • Research Site

    RECRUITING

    Takatsuki-shi, 569-8686, Japan

  • Research Site

    RECRUITING

    Ube, 755-8505, Japan

  • Research Site

    RECRUITING

    Yokohama, 241-8515, Japan

  • Research Site

    RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • Research Site

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Research Site

    RECRUITING

    Maastricht, 6202 AZ, Netherlands

  • Research Site

    WITHDRAWN

    Utrecht, 3584 CX, Netherlands

  • Research Site

    RECRUITING

    Koszalin, 75-581, Poland

  • Research Site

    RECRUITING

    Krakow, 31-501, Poland

  • Research Site

    WITHDRAWN

    Lodz, 92-213, Poland

  • Research Site

    NOT_YET_RECRUITING

    Lodz, 92-213, Poland

  • Research Site

    RECRUITING

    Olsztyn, 10-228, Poland

  • Research Site

    RECRUITING

    Warsaw, 02-034, Poland

  • Research Site

    RECRUITING

    Busan, 48108, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Daegu, 41404, South Korea

  • Research Site

    RECRUITING

    Seongnam-si, 13496, South Korea

  • Research Site

    RECRUITING

    Seongnam-si, 13620, South Korea

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    RECRUITING

    Seoul, 05505, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 06591, South Korea

  • Research Site

    RECRUITING

    Barcelona, 08036, Spain

  • Research Site

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Research Site

    RECRUITING

    Madrid, 28007, Spain

  • Research Site

    RECRUITING

    Madrid, 28040, Spain

  • Research Site

    RECRUITING

    Santander, 39008, Spain

  • Research Site

    RECRUITING

    Kaohsiung City, 82445, Taiwan

  • Research Site

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Research Site

    RECRUITING

    Taichung, 40447, Taiwan

  • Research Site

    RECRUITING

    Taichung, 40705, Taiwan

  • Research Site

    RECRUITING

    Tainan, 704, Taiwan

  • Research Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Research Site

    RECRUITING

    Taipei, 112, Taiwan

  • Research Site

    RECRUITING

    Taoyuan, 333, Taiwan

  • Research Site

    RECRUITING

    Bangkok, 10700, Thailand

  • Research Site

    RECRUITING

    Chiang Mai, 50200, Thailand

  • Research Site

    RECRUITING

    Hat Yai, 90110, Thailand

  • Research Site

    RECRUITING

    Khon Kaen, 40002, Thailand

  • Research Site

    RECRUITING

    Muang, 34000, Thailand

  • Research Site

    RECRUITING

    Ongkharak, 26120, Thailand

  • Research Site

    RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Erzurum, 25240, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Konya, 42080, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Seyhan, 1060, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Glasgow, G12 OYN, United Kingdom

  • Research Site

    RECRUITING

    Greater London, SW3 6JJ, United Kingdom

  • Research Site

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    London, NW3 2QG, United Kingdom

  • Research Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

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