Neoadjuvant Nivolumab for Operable Esophageal Carcinoma

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Nivolumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03987815

2019-01-147-0004

Details and patient eligibility

About

This is a single arm phase II study, in which maximum 3 cycles of nivolumab (240 mg fixed dose every 2 weeks) is administered for T2- or T3-node negative esophageal squamous cell carcinoma, before curative operation.

Enrollment: 20 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed esophageal squamous cell carcinoma
2. Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)
3. ECOG performance 0 or 1
4. Age 19 years or older

Exclusion criteria

1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
2. Ineligibility or contraindication for esophagectomy
3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
5. Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Study Arm

Experimental group

Description:

Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles

Treatment:

Drug: Nivolumab