New combo aims to keep stomach cancer at bay longer
NCT ID NCT04021108
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding radiation therapy to the immunotherapy drug nivolumab can help people with advanced gastroesophageal cancer live longer without their disease getting worse. All 80 participants first receive a short course of chemotherapy (FOLFOX) plus nivolumab. Those whose cancer does not grow are then randomly assigned to continue nivolumab alone or nivolumab plus radiation. The main goal is to see how many patients are still progression-free after 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab (Opdivo) and radiation therapy
- What this could lead to
- If successful, this could point toward a more effective treatment strategy for advanced gastroesophageal cancer, potentially extending the time patients live without their cancer growing.
- What could go wrong
- This is a small, early-phase study (80 people) and results may not apply to all patients. Adding radiation to immunotherapy also carries risks of increased side effects, and the benefit over standard care is not yet proven.
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
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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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80 people
The number who actually took part.
- Started
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Jul 2019
- Expected to finish
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Jun 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 * Subjects with a diagnosis of advanced unresectable or metastatic gastroesophageal adenocarcinoma (eg. gastric, gastroesophageal junction, and esophageal adenocarcinoma) * Be willing and able to provide written informed consent/assent for the trial * Age \> 18 years * ECOG performance status ≤ 1 * Absolute neutrophil count ≥ 1,500/mL * Platelets ≥ 100,000/mL * Total bilirubin ≤ 1.5x upper limits of normal, unless the patient has known Gilbert's disease. * AST/ALT ≤ 2.5 upper limits of normal, or \< 5x ULN for subjects with liver metastases * Creatinine ≤ 1.5 mg/dl. If Creatinine \> 1.5 mg/dl, creatinine clearance \> 60 ml/min * Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 28 days prior to initiation of treatment on Day 1. * For all males and females of childbearing potential, they should be agreeable to use an adequate method of contraception or birth control. For females of child bearing potential, a negative pregnancy test within 7 days of start of study drug is required Exclusion Criteria * Prior cytotoxic therapy for metastatic or incurable disease. * Patients may have had prior therapy with curative intent for localized disease, if their recurrence or disease progression was more than six months from completing prior therapy. * HER2 positive adenocarcinoma * Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. * Known history of active TB (Bacillus Tuberculosis) * Known additional malignancy that is active. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Previous invasive malignancy treated with curative intent less than 3 years from time of registration. Exceptions include prostate cancer or basal cell skin cancer. * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Known history of, or any evidence of active, non-infectious pneumonitis. * Active infection requiring systemic therapy. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. * Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). * Has received a live vaccine within 30 days of planned start of study therapy.
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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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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Roswell Park Cancer Center
Buffalo, New York, 14203, United States
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University of Nebraska
Omaha, Nebraska, 68105, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Weill Cornell Medicine
New York, New York, 10065, United States
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