Neoadjuvant Nivolumab for Operable Esophageal Carcinoma

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Nivolumab

• Registration Number: NCT03987815
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-17
• Study Start: 2019-08-01
• Status Verified: 2019-12
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-17
• Primary Completion: 2021-12-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm	Nivolumab	Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles

Primary Outcome Measures

Name	Time	Method
Major pathologic response	2 months	Viable tumor comprised ≤ 10% of resected tumor specimens

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	2 months	Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions
Positron Emission Tomography (PET)-CT response	2 months	Complete metabolic response is defined as the SUV of 2.5 or less than 2.5 of primary tumor
Progression-free survival (PFS)	24 months	Time from the enrollment to disease relapse after complete resection or death from any cause
Overall survival (OS)	24 months	Time from the enrollment to death of any cause

Trial Locations

Locations (1)

Jong-Mu Sun; 🇰🇷 Seoul, Korea, Republic of