Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

In brief

The purpose of this study is to test the safety of adding a new drug, durvalumab (also called MEDI4736), to chemoradiation with either FOLFOX/Capeox or carboplatin and paclitaxel, following initial chemotherapy with FOLFOX. The investigators want to find out what effects, good and/or bad, this combination has on the patient and cancer.

Key facts

Study ID

NCT02962063

Run by

Memorial Sloan Kettering Cancer Center

People needed

64

Starts

2016-11-01

Expected to finish

2026-11-01

Last updated by the study team

2025-09-05

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction (GEJ). Pathology must be confirmed at Memorial Sloan Kettering Cancer Center
• Tumors that are Her2 positive are eligible
• Availability of archived tumor tissue for banking
• TanyN+M0 or T3-4NanyM0 tumors
• Disease must be clinically limited to the esophagus or GEJ. GEJ tumors must be Siewert Type I-III
• No prior chemotherapy
• Prior radiation is permitted, provided it does not limit the ability to deliver per-protocol radiation in the opinion of the treating radiation oncologist
• Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon
• mSUV in the primary tumor must be ≥5.0
• Patients must be ≥18 years of age
• Eastern Cooperative Oncology Group performance status of 0-1
• Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause;
• OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry
• Adequate organ function defined at baseline as:
• WBC ≥3,000/ L
• ANC ≥1,500/ L
• Platelets ≥100,000/ L
• Hb ≥9 g/dl
• Calculated creatinine clearance >40 ml/min using Cockcroft-Gault method:
• Males:
• Creatinine CL = Weight (kg) x (140 - Age) . (mL/min) 72 x serum creatinine (mg/dL)
• Females:
• Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
• Total serum bilirubin ≤1.5 mg/dL
• AST/ALT ≤2.5× upper limit of normal

You may not qualify if…

• Carcinoma in-situ and tumors determined to be T1-2N0
• Tumors with significant involvement of the proximal stomach which, in the opinion of the treating thoracic surgeon, would require an esophagogastrectomy
• Patients with evidence of metastatic disease, including:
• Positive malignant cytology of the pleural, pericardium or peritoneum
• Radiographic evidence of distant organ involvement
• Non-regional lymph nodes that cannot be contained within a radiation field
• Biopsy-proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. Recurrent laryngeal or phrenic nerve paralysis
• Grade 2 ≥ peripheral neuropathy
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to 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
• History of pneumonitis
• The use of immunosuppressive medication within 28 days prior to the first dose of durvalumab-/tremelimumab. The following are exceptions to this criterion:
• Intranasal, topical, inhaled corticosteroids or local steroid injections (e.g. intraarticular injection)
• Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent
• Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
• Known HIV positivity
• Chronic Hepatitis B or known Hepatitis C infection (e.g. Hepatitis B surface Ag positive or detectable viral load for Hepatitis B). Patients with prior evidence of Hepatitis B or C without active infection are eligible
• Known history of previous clinical diagnosis of tuberculosis
• Uncontrolled seizures
• Pregnant or breast-feeding women. Women of childbearing potential (WOCBP) must undergo a negative pregnancy test (either serum or urine) prior to study entry. Male and female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception throughout their participation in the study and for 90 days after last dose of study drug. WOCBP include:
• Any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal (defined as amenorrheic ≥12 consecutive months)
• Women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/ml
• Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods to prevent pregnancy or are practicing abstinence of where the partner is sterile
• Prior malignancy (other than basal cell/squamous cell carcinoma of the skin, in-situ cervical carcinoma or superficial transitional cell bladder carcinoma) diagnosed and/or treated within three years of study entry

Where it is running

• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Rockville Centre — Rockville Centre, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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