Active Clinical Trials
An Investigational Immuno-therapy Study of Nivolumab or Placebo in Patients With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)
In subjects with resected esophageal (EC) and gastroesophageal juion (GEJ) cancer, the administration of nivolumab will improve overall survival (OS), Disease-free survival (DFS) or both compared with placebo.
This study has co-primary objectives:
- To compare OS of nivolumab versus placebo in subjects with resected EC or GEJ cancer.
- To compare DFS of nivolumab versus placebo in subjects with resected EC or GEJ cancer.
- Secondary objectives:
- To evaluate 1, 2, and 3 year survival rates of nivolumab versus placebo in subjects with resected EC or GEJ cancer.
Key Inclusion Criteria
- All subjects must have Stage II or Stage III (per AJCC 7th edition) carcinoma of the esophagus or gastroesophageal juion and have histologically confirmed predominant adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal juion cancer at the time of initial diagnosis.
- Subjects must complete pre-operative chemoradiotherapy followed by surgery prior to randomization. Platinum based chemotherapy should be used. Chemotherapy and radiation regimens can be followed as local standards of care per NCCN or ESMO guidelines.
- Subject must have complete resection (R0), have been surgically rendered free of disease with negative margins on resected specimens. Subject must have residual pathologic disease, i.e. non-pathologic complete response (non-pCR) of their EC or GEJ, with at least ypN1 or ypT1 listed in the pathology report of resected specimens.The pathology reports of detectable lesion(s) confirming malignancy must be reviewed, dated, and signed by the investigator prior to randomization.
- Complete resection must be performed in a window of 4-12 weeks prior to randomization.
- ECOG performance status score of 0 or 1.
- All subjects must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging studies must include CT scan of chest, and abdomen.
- Tumor tissue from the resected site of disease must be provided for biomarker analyses. In order to be randomized, a subject must have a PD-L1 expression classification (≥1%, < 1% or indeterminate) as determined by the central lab. If insufficient tumor tissue content is provided for analysis, acquisition ofadditional archived tumor tissue (block and /or slides) for the biomarker analysis is required.
Key exclusion criteria
- Subjects with cervical esophageal carcinoma. Location of tumor as it relates to eligibility can be discussed with BMS medical monitor.
- Subjects who do not receive concurrent CRT prior to surgery. Subjects who only receive chemotherapy or only radiation prior to surgery are not eligible.
- Subjects with Stage IV resectable disease.
- Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger arepermitted to enroll.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence ofactive autoimmune disease.