Nivolumab in Patients With Type B3 Thymoma and Thymic Carcinoma (NIVOTHYM)

NCT03134118 | Unknown Phase 2 DMC

• 3 other identifiers: EORTC-15252015-005504-28ETOP 11-16
• Study Type: interventional
• Target: 55
• Locations: 6 countries
• Sites: 20

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.

Conditions

Thymoma Type B3; Thymic Carcinoma

Keywords

Thymoma; Phase II; nivolumab; Thymic carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Rate (PFSR) at month 6

  The Progression Free Survival Rate (PFSR) analysis will be performed at month 6

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  32 months after first patient in

• Overall Survival (OS)

  32 months after first patient in

• Toxicity according CTCAE version 4.03

  32 months after first patient in

• Overall Response Rate (ORR)

  32 months after first patient in

• Disease Control Rate (DCR)

  32 months after first patient in

Study Arms (1)

Nivolumab

EXPERIMENTAL

Patients will be centrally registered and will receive nivolumab 240 mg IV every 2 weeks

Drug: Nivolumab

Interventions

Nivolumab DRUG

Patients will be centrally registered and will receive nivolumab 240 mg IV every 2 weeks

Also known as: BMS-936558-01

Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.1.
• 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:
• white blood count ≥ 2 × 109/L;
• haemoglobin \>9 g/dL;
• platelet count \>100 × 109/L;
• Adequate liver function:
• Total bilirubin \<1.5 × ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL);

You may not qualify if:

• 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;
• Live vaccines within 30 days prior to the first dose of study therapy and while participating in study. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, H1N1 flu, rabies, BCG, and typhoid vaccine.
• Autoimmune paraneoplastic syndrome requiring immunosuppressive or dedicated treatment. A specific attention should be given in order to detect any minor myasthenia signs at enrollment; acetylcholine receptor antibodies will be systematically tested when symptoms are suggestive of a myasthenia;
• History of any other hematologic or primary solid tumor malignancy, unless in remission for at least 5 years. A pT1-2 prostatic cancer Gleason score \< 6, superficial bladder cancer, non melanomatous skin cancer or carcinoma in situ of the cervix is eligible;
• Previous allogeneic tissue/solid organ transplant;
• Active infection requiring therapy;

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• ETOP IBCSG Partners Foundation: collaborator

Study Sites (20)

Institut Jules Bordet

Brussels, Belgium

Location

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Belgium

Location

CHU de Brest

Brest, 29200, France

Location

CHU de Lyon - Hopital Louis Pradel

Bron, 69500, France

Location

Centre Francois Baclesse

Caen, 14076, France

Location

CHU de Grenoble - La Tronche - Hôpital A. Michallon

La Tronche, 38700, France

Location

Assistance Publique - Hopitaux de Marseille - Hopital Nord (APHM)

Marseille, France

Location

Institut Curie- Hopital de Paris

Paris, 75248, France

Location

CHU Toulouse - Hopital Larrey

Toulouse, 31059, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

Amsterdam, 1066, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Vall d'Hebron Institut d'Oncologia

Barcelona, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, Spain

Location

UniversitaetsSpital Zurich

Zurich, Switzerland

Location

NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

Glasgow, United Kingdom

Location

Royal Marsden Hospital - Chelsea, London

London, United Kingdom

Location

Royal Marsden Hospital - Sutton, Surrey

Sutton, United Kingdom

Location

The Christie NHS Foundation Trust

Wythenshawe, M23 9LT, United Kingdom

Location

Related Publications (1)

• Remon J, Girard N, Novello S, de Castro J, Bigay-Game L, Bernabe R, Greillier L, Mosquera J, Cousin S, Juan O, Sampayo M, Besse B. PECATI: A Multicentric, Open-Label, Single-Arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-Thymoma and Thymic Carcinoma Patients. Clin Lung Cancer. 2022 May;23(3):e243-e246. doi: 10.1016/j.cllc.2021.07.008. Epub 2021 Jul 20.

  PMID: 34393061 DERIVED

MeSH Terms

Conditions

Thymoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Nicolas Girard

  Institut Curie, Paris, France

  PRINCIPAL INVESTIGATOR

• Solange Peters

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: April 28, 2017
• Study Start: April 11, 2018
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

BE (2); ES (2); NL (3); CH (1); FR (8); GB (4)