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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508658-24-00

Acronym

1525-LCG

Enrollment

Registered

2024-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type B3 thymoma and thymic carcinoma

Brief summary

Progression Free Survival Rate at 6 months (PFSR-6) per independent radiological review

Detailed 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

Interventions

DRUGIPILIMUMAB

DRUGNIVOLUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival Rate at 6 months (PFSR-6) per independent radiological review	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

—

Countries

Belgium, France, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026