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Promising cancer combo study pulled before it even started

NCT ID NCT07283848

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study aimed to see if adding two immune-boosting drugs (zimberelimab and domvanalimab) to standard chemotherapy could help people with operable stomach or esophageal cancer. All participants would have received the treatment before and after surgery, then be followed for up to 5 years. However, the study was withdrawn before enrolling any participants, so no results are available.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Inclusion Criteria: * Participants must have histologically proven adenocarcinoma of the stomach or gastroesophageal junction (GEJ), including Siewert I-III adenocarcinomas of the GEJ * Tumors must have a programmed death ligand-1 (PDL1) expression score of at least 1 or greater (≥1) by any testing method (any conventional immunohistochemistry assay and any calculation) * Participants must be treatment naïve. * Age ≥18 years. * ECOG performance status ≤1 * Participants must have adequate organ and marrow function as defined below: * leukocytes ≥2,000/mcL * absolute neutrophil count ≥1,500/mcL * hemoglobin \> 9 g/dL * platelets ≥100,000/mcL * total bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless documented Gilbert's disease * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN * Creatinine clearance ≥50 mL/min. * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients must have been deemed to have resectable disease by the medical oncology provider after reviewing with the multidisciplinary team including surgery. This must be documented in the medical record by the medical oncologist. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation including six months after last study dose. * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of domvanalimab and/or zimberelimab administration. Males who have had a successful vasectomy (confirmed azoospermia, documentation needed) require no additional contraception. * Ability to understand and the willingness to sign a written informed consent document. * The participant is a non-smoker or light smoker who smokes no more than 10 cigarettes, 2 cigars, 2 pipes, or other nicotine equivalents (eg, vape, snuff, gum) of tobacco per day; willing to limit smoking during the treatment period to 4 cigarettes or 1 cigar per day. Exclusion Criteria: * Prior anti-PD-1/PD-L1/TIGIT treatment * Participants who are receiving any other investigational agents or other anticancer therapies. * Patients with brain metastases are excluded. Brain metastases constitute stage IVB disease and are not approached with curative intent and are therefore excluded. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to domvanalimab or zimberelimab * Subjects with any condition requiring systemic treatment with either corticosteroids (\>2mg daily dexamethasone equivalent) or other immunosuppressive medications within 14 days of treatment. Premedication for hypersensitivity reactions (e.g. to contrast for CT or gadolinium for MRI) is allowed. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), idiopathic pneumonitis, or clinical evidence of active pneumonitis. History of radiation pneumonitis/fibrosis in the radiation field is permitted. * Participants with uncontrolled intercurrent illness that would interfere with ability to participate in the opinion of the treating investigator. * Participants with psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and/or nursing women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with domvanalimab or zimberelimab. * Patients with a history of another primary malignancy that is currently clinically significant and has potential for metastases or currently requires active intervention (except for hormonal therapy for breast or prostate cancer). * New York Heart Association \[NYHA\] Class III or IV (see Appendix D, New York Heart Association \[NYHA\] Classification) within the previous 2 months; if \>2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms. * HIV Infection: Participants with a known history of Human Immunodeficiency Virus (HIV) infection are excluded unless they meet all of the following criteria: * Stable antiretroviral therapy (ART) for at least 12 weeks prior to enrollment. * No history of AIDS-defining conditions. * CD4+ T-cell count ≥ 350 cells/mm³ at screening. * HIV viral load ≤ 50 copies/mL at screening. * No significant comorbidities associated with HIV infection that could interfere with the safety or efficacy of the investigational treatment. * No concurrent use of prohibited medications that may interfere with the study drug or cancer therapy. * Fredericia's corrected QT interval (QTcF) ≥ 450 ms for men and ≥ 470 ms for women on ECG conducted during screening. * Active systemic infection requiring intravenous antibiotics or intravenous monoclonal antibody treatments within 7 days of cycle 1 day 1. * Use of any live vaccines against infectious diseases within 28 days of first dose of study drug. * History of trauma or major surgery within 28 days prior to the first dose of study drug (placement of central venous access catheter \[eg, port or similar\] is not considered a major surgical procedure). * Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Any history of clinically significant pulmonary embolism within 30 days causing clinical symptoms including but not limited to shortness of breath, pleuritic chest pain, dyspnea on exertion and/or evidence of unresolved right heart strain on EKG or echocardiography. * History of allogeneic stem cell or solid organ transplantation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States