Single-arm, Multicentre, Phase II Study of Immunotherapy in Patients With Type B3 Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy

European Organisation for Research and Treatment of Cancer - EORTC20 sites in 6 countries55 target enrollmentApril 11, 2018

ConditionsThymoma Type B3 Thymic Carcinoma

InterventionsNivolumab

DrugsNivolumab

Overview

Phase: Phase 2
Intervention: Nivolumab
Conditions: Thymoma Type B3
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Enrollment: 55
Locations: 20
Primary Endpoint: Progression Free Survival Rate (PFSR) at month 6
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 11, 2018

End Date

July 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Relapsed/advanced thymoma B3 and thymic carcinoma not amenable to curative-intent radical treatment;
•At least one previous line of platinum-based chemotherapy for advanced disease
•Patients treated with neo-adjuvant or adjuvant platinum based chemotherapy combined with radical surgical or as part of radical chemoradiotherapy are eligible if chemotherapy was completed less than 6 months before enrollment;
•Radiological progression documented per RECIST 1.1 during or after completion of previous line therapy;
•Presence of measurable disease according to RECIST 1.
•Disease status must be documented by full chest and upper abdomen (including adrenal glands) CT and/or MRI within 28 days of study enrollment. If clinically indicated, brain imaging must be performed
•At least 18 years;
•WHO Performance Status (PS) 0-2 Note: for the cohort of patient that will be treated with nivolumab and ipilimumab: PS 0-1
•Availability of FFPE tumor tissue (a tumour block or 10 unstained slides), notably for PD-L1 Immunohistochemistry (IHC) expression assessment. Archival material is allowed. Patients will be eligible to participate regardless of the level of PD-L1 expression, however tissue must be considered adequate (assessed by a local pathologist) for characterization of PD-L1 status as per procedure manual;
•Adequate hematological function:

Exclusion Criteria

•No evidence of active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable (i.e. without evidence of progression by imaging for at least four weeks prior to the enrollment and any neurologic symptoms have returned to baseline), and have not received steroids (for a total equivalent dose of more than 10mg of prednisone per day) for at least 7 days prior to enrollment;
•Prior treatment with anti-PD-1, anti-PD-L1/2, anti- CD137, CTLA-4 modulators;
•Current participation to any other clinical research nor treatment with an investigational agent or use of an investigational device within 4 weeks of the enrollment;
•Known history or current evidence of active Hepatitis B (e.g., HBsAg reactive) or C (e.g., HCV RNA\[qualitative\] is detected) or Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies);
•Known contra-indications for CT with IV contrast
•Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 15 days prior to enrollment
•Corticosteroid use as premedication for IV contrast allergies/reactions is allowed;
•Daily prednisone at doses up to 10 mg or equivalent doses of any othe corticosteroid is allowed for example as replacement therapy
•No history of interstitial lung disease (ILD) OR pneumonitis (other than COPD exacerbation) that has required oral or IV steroids;
•Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed;