Nivolumab re-challenge study

JRCT ID: jRCTs051180019

Registered date:28/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: nsclc
• Date of first enrollment: 20/12/2015
• Target sample size: 60
• Study type: Interventional
• Intervention(s): nivolumab (240mg/body) q2w, until disease progression.

Outcome(s)

• Primary Outcome: objective response rate
• Secondary Outcome: disease control rate, progression free survival, safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Clinical benefit was obtained by prior ICI, and progressed. Clinical benefit is defined as complete response, partial response, or disease control rate 6 or > 6 months. Any combination regimen was allowed if included ICI.
Prior ICI was completed 60 or > 60 days of registration
ECOG performance status (PS) of 0-1

Exclude criteria

Without symptomatic brain metastasis
History of severe immune related adverse events during prior ICI.
With active autoimmune disease. Patients who have controlled thyroid dysfunction or skin disease which does not require systemic therapy are allowed.
Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis on chest computed tomography. ICI induced pneumonitis is allowed if patients' lung infiltration is stable and is free from systemic steroid 90 or > 90 days.
Pregnant or nursing women, or women unwilling to use contraceptive methods.
Serious psychiatric condition that makes registration difficult.
Known serious allergy.

Related Information

• Primary Sponsor: Teraoka Shunsuke
• Secondary Sponsor: Akamatsu Hiroaki
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.,Bristol-Myers Squibb Company
• Secondary ID(s): UMIN000028561