Nivolumab in Patients With Type B3 Thymoma and Thymic Carcinoma (NIVOTHYM)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Study ID
- NCT03134118
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Thymic Carcinoma
- Thymoma Type B3
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGPatients will be centrally registered and will receive nivolumab 240 mg IV every 2 weeks
Study Details
The aim of the phase II Nivothym study is to collect data on activity and toxicity of nivolumab therapy in patients with thymic carcinoma or type B3 thymoma that previously received a first platinum-based chemotherapy.
Key Dates
- Start date
- Apr 11, 2018
- Status verified
- May 2026
- Primary completion
- Sep 5, 2023
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 55 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: NivolumabPatients will be centrally registered and will receive nivolumab 240 mg IV every 2 weeks
Primary Outcome Measure
Progression Free Survival Rate (PFSR) at month 6 [ Time Frame: The Progression Free Survival Rate (PFSR) analysis will be performed at month 6 ]
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