New combo therapy targets Hard-to-Treat stomach cancers in Mid-Stage trial

NCT ID NCT05836584

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This phase II trial is testing whether adding chemotherapy to the immunotherapy drug atezolizumab works better than atezolizumab alone for patients with a specific genetic type of stomach or gastroesophageal junction cancer (MSI-H/dMMR). The study involves 240 adults with localized or locoregional disease. Participants receive treatment before and after surgery, and researchers are tracking how long the cancer stays away and overall survival.

What this could mean

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

Active substance: Atezolizumab (immunotherapy) with or without chemotherapy (docetaxel, oxaliplatin, leucovorin, fluorouracil, capecitabine)
What this could lead to: If successful, this could lead to a new treatment option that shrinks or stabilizes MSI-H/dMMR stomach cancers before and after surgery, potentially delaying or preventing recurrence.
What could go wrong: This is a phase II trial with 240 participants, so results are still early. The combination may not improve outcomes over immunotherapy alone, and side effects from both immunotherapy and chemotherapy can be serious.

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.

Participants

2 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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: * Patient must be \>= 18 years of age * Patient must have histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma that is MSI-H/dMMR (microsatellite instability-high/mismatch repair deficient) as determined by one of three methods: * Deficient deoxyribonucleic acid (DNA) mismatch repair protein (MMR) expression status: MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR. dMMR may be determined either locally or by site-selected reference lab by Clinical Laboratory Improvement Act (CLIA)-certified assay * NOTE: Loss of MLH1 and PMS2 commonly occur together * Polymerase chain reaction (PCR) determined microsatellite instability * MSI-H tumor status determined by next-generation sequencing * Patient must have previously untreated localized gastric, or Siewert type II or III GEJ (gastroesophageal junction) adenocarcinoma. Tumors must be staged as T2 or greater primary lesion or be any T stage with the presence of positive locoregional lymph nodes- N+ (clinical nodes) without evidence of metastatic disease * Siewert type II tumors: tumors located between 1 cm proximal and 2 cm distal to the GEJ * Siewert type III tumors: tumors located between 2 and 5 cm distal to GEJ * Patient must be amenable to surgical resection with therapeutic intent * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) \>= 1,500/mcL (obtained =\< 14 days prior to randomization) * Platelets \>= 100,000/mcL (obtained =\< 14 days prior to randomization) * Hemoglobin \>= 9 g/dL (obtained =\< 14 days prior to randomization) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) OR direct bilirubin =\< ULN (for patients with total bilirubin \> 1.5 x ULN) (obtained =\< 14 days prior to randomization) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]): x =\< 3 institutional ULN (obtained =\< 14 days prior to randomization) * Creatinine =\< 1.5 x institutional ULN OR glomerular filtration rate (GFR) \> 50 mL/min/1.73m\^2 (obtained =\< 14 days prior to randomization) * Albumin \>= 2.5 g/dL (obtained =\< 14 days prior to randomization) * International normalized ratio (INR) OR prothrombin time (PT) =\< 1.5 x ULN (unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time \[PTT\] is within therapeutic range of intended use of anticoagulants) (obtained =\< 14 days prior to randomization) * Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants) (obtained =\< 14 days prior to randomization) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Patient must have no contraindications to receive one of the chemotherapy regimens: FLOT or mFOLFOX / CAPOX * Patient must not have had prior potentially curative surgery for carcinoma of the stomach/GEJ * Patient must not receive any other standard anti-cancer therapy or experimental agent concurrently with the study drugs * Patient must have recovered from clinically significant adverse events of their most recent therapy/intervention prior to randomization * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patient must have chest/abdomen/pelvis CT completed within 4 weeks prior to randomization * Patient may not have received prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PDL-1, anti-PDL-2, anti-CTLA4 monoclonal antibody) * Patient must not have received any live vaccines within 30 days prior to randomization and while participating in the study. Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and coronavirus disease 2019 (COVID-19) (Note: intranasal influenza vaccines, such as Flu-Mist \[registered trademark\] are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events) * Patient must not have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain- Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis and hepatitis. Patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome are ineligible because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but otherwise are eligible. * Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event) * Patients must not be receiving systemic steroid therapy equivalent to \> 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to randomization. Topical corticosteroid or occasional inhaled corticosteroids are allowed * Patient must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity, and must not have a known history of prior pneumonitis requiring treatment with steroids, or any evidence of active, non-infectious pneumonitis * Patient must not have a known history of active TB (Bacillus Tuberculosis) * Patient must not have any hypersensitivity to atezolizumab or any of its excipients * Patient must not have received any prior chemotherapy, targeted small molecule therapy, or radiation therapy for their MSI-H/dMMR gastric and GEJ cancer * Patient must not have had an allogeneic bone marrow/stem, cell or solid organ transplant * Patient must not have a history or current evidence of any condition (e.g., known deficiency of the enzyme dihydropyrimidine dehydrogenase \[DPD\]), therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator * Patient must not have any condition that would interfere with the cooperation with the requirements of this trial * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on protocol treatment. Patients of childbearing potential must continue contraception measures for 5 months after the last dose of atezolizumab and for 9 months after the last dose of chemotherapy. Male patients with partners of childbearing potential must continue contraception measures for 6 months after the last dose of chemotherapy. Patients of childbearing potential must also not breastfeed while on treatment and for 5 months after the last dose of atezolizumab and for 3 months after the last dose of chemotherapy * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * The investigator must declare the chemotherapy regimen their patient will receive (FLOT or mFOLFOX / CAPOX) prior to randomization

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric carcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

Clinical stage I gastric cancer ajcc V8 Clinical stage I gastroesophageal junction adenocarcinoma ajcc V8 Clinical stage II gastric cancer ajcc V8 Clinical stage II gastroesophageal junction adenocarcinoma ajcc V8 Clinical stage III gastric cancer ajcc V8 Clinical stage III gastroesophageal junction adenocarcinoma ajcc V8 Clinical stage IVA gastric cancer ajcc V8 Clinical stage IVA gastroesophageal junction adenocarcinoma ajcc V8 Gastric adenocarcinoma Gastroesophageal junction adenocarcinoma

Contacts and locations

Locations

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127, United States
Beacon Kalamazoo Cancer Center

Kalamazoo, Michigan, 49009, United States
Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States
Beebe South Coastal Health Campus

Millville, Delaware, 19967, United States
Bronson Battle Creek

Battle Creek, Michigan, 49017, United States
Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States
Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States
Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States
Cancer Hematology Centers - Flint

Flint, Michigan, 48503, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle at The Riverfront

Danville, Illinois, 61832, United States
Chelsea Hospital

Chelsea, Michigan, 48118, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120, United States
Corewell Health Reed City Hospital

Reed City, Michigan, 49677, United States
Crossroads Cancer Center

Effingham, Illinois, 62401, United States
Fairview Southdale Hospital

Edina, Minnesota, 55435, United States
Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States
Helen F Graham Cancer Center

Newark, Delaware, 19713, United States
Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States
Henry Ford Health Warren Hospital

Warren, Michigan, 48093, United States
Henry Ford Madison Heights Hospital - Breast

Warren, Michigan, 48093, United States
Henry Ford River District Hospital

East China Township, Michigan, 48054, United States
Henry Ford Saint John Hospital - Breast

Grosse Pointe Woods, Michigan, 48236, United States
Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044, United States
Henry Ford Saint John Hospital - Van Elslander

Grosse Pointe Woods, Michigan, 48236, United States
Henry Ford Warren Hospital - Breast Macomb

Macomb, Michigan, 48044, United States
Henry Ford Warren Hospital - GLCMS

Warren, Michigan, 48093, United States
Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States
Illinois CancerCare - Washington

Washington, Illinois, 61571, United States
Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton

Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States
Illinois CancerCare-Dixon

Dixon, Illinois, 61021, United States
Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States
Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru

Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Kaiser Permanente Downtown Commons

Sacramento, California, 95814, United States
Kaiser Permanente Dublin

Dublin, California, 94568, United States
Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States
Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, 96819, United States
Kaiser Permanente San Leandro

San Leandro, California, 94577, United States
Kaiser Permanente-Fremont

Fremont, California, 94538, United States
Kaiser Permanente-Fresno

Fresno, California, 93720, United States
Kaiser Permanente-Modesto

Modesto, California, 95356, United States
Kaiser Permanente-Oakland

Oakland, California, 94611, United States
Kaiser Permanente-Roseville

Roseville, California, 95661, United States
Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States
Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States
Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States
Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States
Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States
Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States
Kaiser San Rafael-Gallinas

San Rafael, California, 94903, United States
Mary Greeley Medical Center

Ames, Iowa, 50010, United States
McFarland Clinic - Ames

Ames, Iowa, 50010, United States
McFarland Clinic - Boone

Boone, Iowa, 50036, United States
McFarland Clinic - Jefferson

Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158, United States
McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501, United States
Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States
Memorial Hospital East

Shiloh, Illinois, 62269, United States
Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States
Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States
Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States
Mount Sinai Hospital

New York, New York, 10029, United States
Mount Sinai West

New York, New York, 10019, United States
Munson Medical Center

Traverse City, Michigan, 49684, United States
MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States
MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764, United States
Northwest Cancer Center - Crown Point

Crown Point, Indiana, 46307, United States
Northwest Cancer Center - Hobart

Hobart, Indiana, 46342, United States
Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, 46383, United States
Northwest Oncology LLC

Dyer, Indiana, 46311, United States
Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604, United States
Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States
Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States
Providence Newberg Medical Center

Newberg, Oregon, 97132, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States
Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Saint Catherine Hospital

Indianapolis, Indiana, 46312, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Saint Mary Medical Center

Hobart, Indiana, 46342, United States
Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661, United States
Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States
Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States
Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
Springfield Clinic

Springfield, Illinois, 62702, United States
Springfield Memorial Hospital

Springfield, Illinois, 62781, United States
The Community Hospital

Munster, Indiana, 46321, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States
Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States
Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States
UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States
United Hospital

Saint Paul, Minnesota, 55102, United States
University of Michigan Health - West

Wyoming, Michigan, 49519, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718, United States
University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States
VCU Community Memorial Health Center

South Hill, Virginia, 23970, United States
VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States
Women's Diagnostic Center - Munster

Munster, Indiana, 46321, United States

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