Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation B… (NCT02962063) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer
United States64 participantsStarted 2016-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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…