Triple-Drug cocktail shows promise for tough stomach cancer
NCT ID NCT04757363
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining an immunotherapy drug (nivolumab) with standard chemotherapy (FOLFOX) and a targeted therapy (regorafenib) can safely control HER2-negative metastatic esophagogastric cancer. About 39 adults with advanced cancer that has spread will receive the combination. The goal is to see if this approach improves how long the cancer stays under control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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39 people
The number who actually took part.
- Started
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Feb 2021
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patients must have histologically or cytologically confirmed metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma * Patients must have disease that can be evaluated radiographically within 28 days of the start of study treatment. This may be measurable disease or non-measurable disease per RECIST 1.1. * Age 18 years or older * ECOG performance status 0 to 1 * Peripheral neuropathy grade ≤1 * Available archival tissue for correlative analysis (biopsy is required if no archival tissue is available) * Adequate organ function as below: * Absolute neutrophil count ≥1500/mcL * Platelets ≥100,000/mcL * Hemoglobin ≥9 g/dL * Serum creatinine ≤1.5X ULN * Serum total bilirubin ≤1.5X ULN OR Direct bilirubin ≤ULN for s ubjects with total bilirubin levels \>1.5X ULN, except patients with Gilbert's disease (≤3X ULN) * AST and ALT ≤2.5X ULN * Albumin ≥3 mg/dL * ALT, alanine aminotransferase; AST, aminotransferase; ULN, upper limit of normal. Exclusion Criteria: * Confirmed HER2-positive disease (IHC 3+ or 2+, fluorescence in situ hybridization HER2:CEP17 ratio ≥2) ° Note: Participants that are IHC 2+ but negative by FSH w ill be considered HER2- negative and eligible for trial. * Inability to swallow oral pills * Prior chemotherapy for metastatic disease. Patients with metastatic disease after treatment for localized esophagogastric cancer may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if \>6 months have elapsed between the end of adjuvant therapy and registration * Currently participating in a study and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment * Underwent major surgical procedure within 4 weeks of registration * Underwent radiation within 2 weeks of registration * Received prior therapy with regorafenib * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent * Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment * A known history of active Bacillus tuberculosis * A known active central nervous system metastases and/or carcinomatous meningitis * A known history of or any evidence of active, noninfectious pneumonitis * An active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, systemic lupus erythematosus, Wegener syndrome \[granulomatosis with polyangiitis\], myasthenia gravis, Grave's disease, rheumatoid arthritis, hypophysitis, uveitis) within the 3 years before the start of treatment. The following are exceptions to this criterion: * Subjects with vitiligo or alopecia * Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment * A known history of human immunodeficiency virus (HIV 1/2 antibodies) * Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Patients with HBsAg reactive on entecavir may be eligible after consultation with hepatologist and study team. * Received a live vaccine within 30 days of planned start of study therapy * Active or clinically significant cardiac disease, including congestive heart failure-New York Heart Association class \>II, active coronary artery disease, cardiac arrhythmias requiring antiarrhythmic therapy other than beta blockers or digoxin, unstable angina (anginal symptoms at rest), new-onset angina within 3 months before initiation, or myocardial infarction within 6 months before initiation * Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \>90 mm Hg on repeated measurement) despite optimal medical management * Evidence or history of bleeding diathesis or coagulopathy * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through 120 days after the last dose of trial treatment * Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study
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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
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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