Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

Paused · Phase 2/Phase 3

Conditions studied: Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

In brief

This phase II/III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.

Key facts

Study ID

NCT03604991

Run by

National Cancer Institute (NCI)

People needed

278

Starts

2019-05-03

Expected to finish

2026-12-31

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• STEP 1 RANDOMIZATION: Patients must be age >= 18 years
• STEP 1 RANDOMIZATION: Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma (Siewert I and II)
• STEP 1 RANDOMIZATION: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• STEP 1 RANDOMIZATION: Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform an esophagectomy
• STEP 1 RANDOMIZATION: Absolute neutrophil count >= 1,500/mcL (within less than or equal to 14 days prior to randomization)
• STEP 1 RANDOMIZATION: Platelets >= 100,000/mcL (within less than or equal to 14 days prior to randomization)
• STEP 1 RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization)
• STEP 1 RANDOMIZATION: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
• STEP 1 RANDOMIZATION: Serum creatinine =< 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
• STEP 1 RANDOMIZATION: Hemoglobin (Hgb) >= 9 g/dL (within less than or equal to 14 days prior to randomization)
• STEP 1 RANDOMIZATION: Leukocytes >= 3,000/mm\^3 (within less than or equal to 14 days prior to randomization)
• STEP 1 RANDOMIZATION: Patients may not have received prior chemotherapy or radiation therapy for management for this malignancy
• STEP 1 RANDOMIZATION: Patients may not have received prior immunotherapy for management of this malignancy or for any other past malignancy
• STEP 1 RANDOMIZATION: Patients must have no contraindication to receiving either carboplatin or paclitaxel chemotherapy
• STEP 1 RANDOMIZATION: Patients must have no contraindication to receiving radiation therapy
• STEP 1 RANDOMIZATION: Patients with 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, must be excluded. 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, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome must be excluded 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 must be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
• STEP 1 RANDOMIZATION: 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)
• STEP 1 RANDOMIZATION: Patient must NOT have previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions:
• Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR
• Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR
• Date of last evidence of disease
• STEP 1 RANDOMIZATION: Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses =< 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease
• STEP 1 RANDOMIZATION: Patients must have adequate cardiac function including electrocardiogram (EKG) and echocardiogram for any patient with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs
• STEP 1 RANDOMIZATION: For patients with evidence of uncontrolled CHF, myocardial infarction (MI), cardiomyopathy, or myositis, require a cardiac evaluation and clearance including lab tests and cardiology consultation (EKG, creatinine phosphokinase [CPK], troponin, and echocardiogram)
• STEP 1 RANDOMIZATION: Patients must not have a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Testing should be conducted to determine eligibility

Where it is running

• Blanchard Valley Hospital — Findlay, Ohio, United States
• Orion Cancer Care — Findlay, Ohio, United States
• Atrium Medical Center-Middletown Regional Hospital — Franklin, Ohio, United States
• Dayton Physicians LLC-Atrium — Franklin, Ohio, United States
• Dayton Physicians LLC-Wayne — Greenville, Ohio, United States
• Wayne Hospital — Greenville, Ohio, United States
• Cleveland Clinic Cancer Center Independence — Independence, Ohio, United States
• Greater Dayton Cancer Center — Kettering, Ohio, United States
• Kettering Medical Center — Kettering, Ohio, United States
• Cleveland Clinic Cancer Center Mansfield — Mansfield, Ohio, United States
• Hillcrest Hospital Cancer Center — Mayfield Heights, Ohio, United States
• North Coast Cancer Care — Sandusky, Ohio, United States
• Springfield Regional Cancer Center — Springfield, Ohio, United States
• Springfield Regional Medical Center — Springfield, Ohio, United States
• Cleveland Clinic Cancer Center Strongsville — Strongsville, Ohio, United States
• ProMedica Flower Hospital — Sylvania, Ohio, United States
• ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital — Toledo, Ohio, United States
• Dayton Physicians LLC - Troy — Troy, Ohio, United States
• Upper Valley Medical Center — Troy, Ohio, United States
• Saint Joseph Warren Hospital — Warren, Ohio, United States
• South Pointe Hospital — Warrensville Heights, Ohio, United States
• University of Cincinnati Cancer Center-West Chester — West Chester, Ohio, United States
• Cleveland Clinic Wooster Family Health and Surgery Center — Wooster, Ohio, United States
• Saint Elizabeth Youngstown Hospital — Youngstown, Ohio, United States
• Armes Family Cancer Center — Findlay, Ohio, United States

Full record on ClinicalTrials.gov

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