A RANDOMIZED PHASE 3 STUDY OF NIVOLUMAB PLUS IPILIMUMAB OR NIVOLUMAB COMBINED WITH FLUOROURACIL PLUS CISPLATIN VERSUS FLUOROURACIL PLUS CISPLATIN IN SUBJECTS WITH UNRESECTABLE ADVANCED, RECURRENT OR METASTATIC PREVIOUSLY UNTREATED ESOPHAGEAL SQUAMOUS CELL CARCINOMA

BRISTOL MYERS SQUIBB COMPANY,0 sites4 target enrollmentJuly 26, 2017

Conditions-C15 Malignant neoplasm of oesophagus Malignant neoplasm of oesophagus C15

Overview

Phase: 未知
Intervention: Not specified
Conditions: -C15 Malignant neoplasm of oesophagus
Sponsor: BRISTOL MYERS SQUIBB COMPANY,
Enrollment: 4
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 26, 2017

End Date

June 18, 2020

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

BRISTOL MYERS SQUIBB COMPANY,

Eligibility Criteria

Inclusion Criteria

•Subjects must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma (predominant squamous differentiation) of esophagus (per AJCC 7th edition, see Appendix 4\).
•Subjects must have unresectable advanced, recurrent or metastatic ESCC (per AJCC 7th edition 5\.1, see Appendix 4\).
•Subjects must not be amenable to curative approaches such as definitive chemoradiation and/or surgery
•No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease.
•oi .Prior adjuvant, neoadjuvant, or definitive, chemotherapy/radiotherapy/chemoradiotherapy for ESCC is permitted if given as part of curative intent regimen and completed before enrollment. A recurrence\-free period is required for 24 weeks after completion of neoadjuvant or adjuvant chemotherapies, or after completion of multimodal therapies (chemotherapies and chemoradiotherapies) for locally advanced diseases
•ECOG Performance Status of 0 or 1, see Appendix 3
•Subjects must have at least one measurable lesion by CT or MRI per RECIST 1\.1 criteria; radiographic tumor assessment must be performed within 28 days prior to randomization.
•Tumor tissue must be provided for biomarker analyses. Either 1 formalin fixed paraffin embedded (FFPE) tumor tissue block or 15 unstained tumor tissue slides, with an associated pathology report if available, must be submitted for biomarker evaluation prior to study drug administration. The tumor tissue sample may be fresh or archival if obtained within 6 months prior to randomization, and there can have been no systemic therapy (eg, adjuvant) given after the sample was obtained. Tissue must be a core needle biopsy, excisional or incisional biopsy. Fine needle biopsies or drainage of pleural effusions with cytospins are not considered adequate for biomarker review and randomization. Biopsies of bone lesions that do not have a soft tissue component or decalcified bone tumor samples are also not acceptable.
•In order to be randomized, a subject must have a PD\-L1 expression classification ≥ 1% or \< 1%, or indeterminate) as determined by the central lab

Exclusion Criteria

•Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before randomization.
•Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
•Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that a BMS medical monitor be consulted prior to signing informed consent.
•Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
•Prior treatment with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-CD137, or anti\-CTLA 4 antibody, or any other antibody or drug specifically targeting T\-cell co\-stimulation or checkpoint pathways