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New drug combo aims to outperform standard immunotherapy in stomach cancer

NCT ID NCT05568095

Disease control Sponsor: Arcus Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This phase 3 study tests whether a new combination of two immunotherapy drugs (domvanalimab and zimberelimab) plus chemotherapy works better than the current standard (nivolumab plus chemotherapy) for people with advanced stomach, gastroesophageal junction, or esophageal cancer that cannot be removed by surgery or has spread. About 1040 participants will be randomly assigned to one of the two treatment groups. The main goal is to see if the new combo helps people live longer.

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

1,040 people

The number who actually took part.

Started

Nov 2022

Finished

Aug 2026

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: * Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol. * Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Key Exclusion Criteria: * Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to: * Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization. * Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization. * History of prior solid-organ transplantation, including allogenic bone marrow transplantation. * Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial. * Known human epidermal growth factor receptor 2 (HER-2) positive tumor. * Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment. * Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma. * Disease progression within 6 months of completion of neoadjuvant or adjuvant therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus esophageal adenocarcinoma gastric adenocarcinoma gastric neoplasm gastroesophageal adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

Advanced upper gastrointestinal tract adenocarcinoma

Contacts and locations

Locations

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Saint Louis Park, Minnesota, 55426, United States

  • Research Site

    Mineola, New York, 11501, United States

  • Research Site

    New York, New York, 10016, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Durham, North Carolina, 27710, United States

  • Research Site

    Cleveland, Ohio, 44106, United States

  • Research Site

    Cleveland, Ohio, 44111, United States

  • Research Site

    Columbus, Ohio, 43219, United States

  • Research Site

    Mayfield Heights, Ohio, 44124, United States

  • Research Site

    Portland, Oregon, 97225, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Nashville, Tennessee, 37232, United States

  • Research Site

    Dallas, Texas, 75390, United States

  • Research Site

    Fort Worth, Texas, 76104, United States

  • Research Site

    Houston, Texas, 77054, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Seattle, Washington, 98109, United States

  • Research Site

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    Buenos Aires, Argentina

  • Research Site

    La Rioja, Argentina

  • Research Site

    Mar del Plata, Argentina

  • Research Site

    Clayton, Australia

  • Research Site

    Murdoch, Australia

  • Research Site

    Barretos, Brazil

  • Research Site

    Ijuí, Brazil

  • Research Site

    Natal, Brazil

  • Research Site

    Porto Alegre, Brazil

  • Research Site

    Halifax, Canada

  • Research Site

    Montreal, Canada

  • Research Site

    Ottawa, Canada

  • Research Site

    Toronto, Canada

  • Research Site

    La Florida, Chile

  • Research Site

    Port Montt, Chile

  • Research Site

    Providencia, Chile

  • Research Site

    Recoleta, Chile

  • Research Site

    Santiago, Chile

  • Research Site

    Talca, Chile

  • Research Site

    Changchun, China

  • Research Site

    Changzhou, China

  • Research Site

    Fuzhou, China

  • Research Site

    Guangzhou, China

  • Research Site

    Haikou, China

  • Research Site

    Hangzhou, China

  • Research Site

    Hefei, China

  • Research Site

    Shanghai, China

  • Research Site

    Tianjin, China

  • Research Site

    Zhengzhou, China

  • Research Site

    Bordeaux, France

  • Research Site

    Brest, France

  • Research Site

    Caen, France

  • Research Site

    Lille, France

  • Research Site

    Lyon, France

  • Research Site

    Montpellier, France

  • Research Site

    Plérin, France

  • Research Site

    Poitiers, France

  • Research Site

    Toulouse, France

  • Research Site

    Villejuif, France

  • Research Site

    Kutaisi, 4600, Georgia

  • Research Site

    Tbilisi, 112, Georgia

  • Research Site

    Tbilisi, 144, Georgia

  • Research Site

    Tbilisi, 159, Georgia

  • Research Site

    Tbilisi, 186, Georgia

  • Research Site

    Guatemala City, Guatemala

  • Research Site

    Quetzaltenango, Guatemala

  • Research Site

    Happy Valley, Hong Kong

  • Research Site

    Hong Kong, Hong Kong

  • Research Site

    Tuenmen, Hong Kong

  • Research Site

    Budapest, Hungary

  • Research Site

    Kecskemét, Hungary

  • Research Site

    Pécs, Hungary

  • Research Site

    Jerusalem, Israel

  • Research Site

    Petah Tikva, Israel

  • Research Site

    Tel Aviv, Israel

  • Research Site

    Florence, Italy

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    Milan, Italy

  • Research Site

    Milan, Italy

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    Ravenna, Italy

  • Research Site

    Rozzano, Italy

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    Udine, Italy

  • Research Site

    Akashi, Japan

  • Research Site

    Bunkyō City, Japan

  • Research Site

    Chiba, Japan

  • Research Site

    Fukuoka, Japan

  • Research Site

    Kashiwa-shi, Japan

  • Research Site

    Kawasaki, Japan

  • Research Site

    Kōtō City, Japan

  • Research Site

    Matsuyama, Japan

  • Research Site

    Nagaizumi-cho, Japan

  • Research Site

    Nagoya, Japan

  • Research Site

    Niigata, Japan

  • Research Site

    Osaka, Japan

  • Research Site

    Osakasayama-shi, Japan

  • Research Site

    Ota-shi, Japan

  • Research Site

    Saitama, Japan

  • Research Site

    Tokyo, Japan

  • Research Site

    Yokohama, Japan

  • Research Site

    Kaunas, Lithuania

  • Research Site

    Klaipėda, Lithuania

  • Research Site

    Vilnius, Lithuania

  • Research Site

    George Town, Malaysia

  • Research Site

    Kuala Lumpur, Malaysia

  • Research Site

    Kuching, Malaysia

  • Research Site

    Colonia Centro, 94300, Mexico

  • Research Site

    Mexico City, 3100, Mexico

  • Research Site

    Mérida, 97134, Mexico

  • Research Site

    San Pedro Garza García, 66278, Mexico

  • Research Site

    Toluca, 50120, Mexico

  • Research Site

    San Isidro, Peru

  • Research Site

    San Juán de Miraflores, Peru

  • Research Site

    Surquillo, Peru

  • Research Site

    Bacolod City, Philippines

  • Research Site

    Baguio City, Philippines

  • Research Site

    Cebu City, Philippines

  • Research Site

    Manila, Philippines

  • Research Site

    Lublin, Poland

  • Research Site

    Tychy, Poland

  • Research Site

    Warsaw, Poland

  • Research Site

    Coimbra, Portugal

  • Research Site

    Lisbon, Portugal

  • Research Site

    Porto, Portugal

  • Research Site

    Baia Mare, Romania

  • Research Site

    Bucharest, Romania

  • Research Site

    Cluj-Napoca, Romania

  • Research Site

    Craiova, Romania

  • Research Site

    Florești, Romania

  • Research Site

    Iași, Romania

  • Research Site

    Suceava, Romania

  • Research Site

    Belgrade, Serbia

  • Research Site

    Kragujevac, Serbia

  • Research Site

    Busan, South Korea

  • Research Site

    Daegu, South Korea

  • Research Site

    Seongnam, South Korea

  • Research Site

    Seoul, South Korea

  • Research Site

    Barcelona, Spain

  • Research Site

    Madrid, Spain

  • Research Site

    Santander, Spain

  • Research Site

    Valencia, Spain

  • Research Site

    Zaragoza, Spain

  • Research Site

    Bang Phlat, Thailand

  • Research Site

    Hat Yai, Thailand

  • Research Site

    Ubon Ratchathani, Thailand

  • Research Site

    Adana, Turkey (Türkiye)

  • Research Site

    Ankara, Turkey (Türkiye)

  • Research Site

    Edirne, Turkey (Türkiye)

  • Research Site

    Istanbul, Turkey (Türkiye)

  • Research Site

    İzmit, Turkey (Türkiye)

  • Research Site

    Malatya, Turkey (Türkiye)

  • Research Site

    Mamak, Turkey (Türkiye)

  • Research Site

    Van, Turkey (Türkiye)

  • Research Site

    Yakutiye, Turkey (Türkiye)

  • Research Site

    Yüreğir, Turkey (Türkiye)

  • Research Site

    London, United Kingdom

  • Research Site

    Manchester, United Kingdom

  • Research Site

    Oxford, United Kingdom

  • Research Site

    Sutton, United Kingdom

  • Research Site

    Los Angeles, California, 90033, United States

  • Research Site

    Orange, California, 92868, United States

  • Research Site

    Santa Monica, California, 90404, United States

  • Research Site

    New Haven, Connecticut, 06520, United States

  • Research Site

    Washington D.C., District of Columbia, 22057, United States

  • Research Site

    Fort Myers, Florida, 33901, United States

  • Research Site

    St. Petersburg, Florida, 33705, United States

  • Research Site

    Tallahassee, Florida, 32308, United States

  • Research Site

    Louisville, Kentucky, 40202, United States

  • Research Site

    Louisville, Kentucky, 40217, United States

  • Research Site

    New Orleans, Louisiana, 70121, United States

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