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Recruiting Phase 2 2023-508658-24-00

EORTC-1525-LCG: Single-arm, multicenter, phase II study of immunotherapy in patients with type B3 thymoma and thymic carcinoma previously treated with chemotherapy - (Nivothym)

Phase 2 – studying effectiveness and dosage
Conditions: type B3 thymoma and thymic carcinoma

Sponsor: European Organisation For Research And Treatment Of Cancer

trial.available_in: БГ
Overview
Trial status: Authorised Progression Free Survival Rate at 6 months (PFSR-6) according to RECIST 1.1 per local investigator assessment, Safety according to CTCAE v4.0, Overall Response Rate (ORR) according to RECIST 1.1 per local investigator assessment, Disease Control Rate according to RECIST 1.1 per local investigator assessment (DCR), Duration of response according to RECIST 1.1 per local investigator assessment, Progression Free Survival (PFS) according to RECIST 1.1 per local investigator assessment, Overall Survival (OS), Progression Free Survival for patients continuing treatment after progression Progression Free Survival Rate at 6 months (PFSR-6) per independent radiological review
Description
Progression Free Survival Rate at 6 months (PFSR-6) according to RECIST 1.1 per local investigator assessment, Safety according to CTCAE v4.0, Overall Response Rate (ORR) according to RECIST 1.1 per local investigator assessment, Disease Control Rate according to RECIST 1.1 per local investigator assessment (DCR), Duration of response according to RECIST 1.1 per local investigator assessment, Progression Free Survival (PFS) according to RECIST 1.1 per local investigator assessment, Overall Survival (OS), Progression Free Survival for patients continuing treatment after progression
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 99 participants
Interventions
IPILIMUMAB
Drug
NIVOLUMAB
Drug
Locations 4
Belgium (1)
France (1)
Netherlands (1)
Spain (1)
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.08.2024
Registry ID
2023-508658-24-00
Source
euclinicaltrials.eu
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