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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE
NIVOTHYM

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

Rekrutierend

NCT-Nummer:
NCT03134118

Studienbeginn:
April 2018

Letztes Update:
08.03.2021

Wirkstoff:
Nivolumab

Indikation (Clinical Trials):
Carcinoma, Thymoma, Thymus Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC

Collaborator:
European Thoracic Oncology Platform

Studienleiter

Nicolas Girard
Principal Investigator
Institut Curie, Paris, France
Solange Peters
Principal Investigator
University of Lausanne Hospitals

Kontakt

Studienlocations
(3 von 17)

CHU de Grenoble - La Tronche - Hôpital A. Michallon
38700 La Tronche
FranceRekrutierend» Google-Maps
Assistance Publique - Hopitaux de Marseille - Hopital Nord (APHM)
Marseille
FranceRekrutierend» Google-Maps
CHU Toulouse - Hopital Larrey
31059 Toulouse
FranceRekrutierend» Google-Maps
Institut de Cancerologie de Lorraine
54519 Vandœuvre-lès-Nancy
FranceRekrutierend» Google-Maps
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
1066 Amsterdam
NetherlandsRekrutierend» Google-Maps
Academisch Ziekenhuis Maastricht
6202 Maastricht
NetherlandsRekrutierend» Google-Maps
Vall d'Hebron Institut d'Oncologia
Barcelona
SpainRekrutierend» Google-Maps
Centre Hospitalier Universitaire Vaudois
Lausanne
SwitzerlandRekrutierend» Google-Maps
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow
United KingdomRekrutierend» Google-Maps
Royal Marsden Hospital - Chelsea, London
London
United KingdomRekrutierend» Google-Maps
Royal Marsden Hospital - Sutton, Surrey
Sutton
United KingdomRekrutierend» Google-Maps
The Christie NHS Foundation Trust
M23 9LT Wythenshawe
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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 1.1.

- 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);

- ALT and/or AST <2.5 × ULN (< 4 x ULN in case of liver metastasis)

- alkaline phosphatase <5 × ULN;

- Adequate renal function: calculated creatinine clearance ≥50 mL/min (according to

Cockroft- Gault, see below);

- Female CrCl = ((140 - age in years) x weight in kg x 0.85)/ 72 x serum creatinine in

mg/dL;

- Male CrCl = ((140 - age in years) x weight in kg x 1.00)/72 x serum creatinine in

mg/dL;

- Women of child bearing potential (WOCBP) must have a negative serum pregnancy test

within 72 hours prior to the first dose of study treatment.

Note: women of childbearing potential are defined as premenopausal females capable of

becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months,

with the exception of those who had prior hysterectomy). However, women who have been

amenorrheic for 12 or more months are still considered to be of childbearing potential if

the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight,

ovarian suppression or other reasons.

- Patients of childbearing / reproductive potential should use adequate birth control

measures, as defined by the investigator, during the study treatment period and for at

least 5 months for a woman and 7 months for a man after the last study treatment. A

highly effective method of birth control is defined as a method which results in a low

failure rate (i.e. less than 1% per year) when used consistently and correctly. Such

methods include:

- Combined (estrogen and progestogen containing) hormonal contraception associated with

inhibition of ovulation (oral, intravaginal, transdermal)

- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral,

injectable, implantable)

- Intrauterine device (IUD)

- Intrauterine hormone-releasing system (IUS)

- Bilateral tubal occlusion

- Vasectomized partner

- Sexual abstinence

- Female patients who are breast feeding should discontinue nursing prior to the first

dose of study medication and must not be breast feeding during the trial treatment and

for a period of at least 5 months following the last administration of trial drug(s).

- Before patient registration, written informed consent must be given according to

ICH/GCP, and national/local regulations

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;

- 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;

- Surgery or chemotherapy related toxicity (toxicity resolved to grade 1, with the

exception of alopecia, fatigue, neuropathy and lack of appetite /nausea);

- Severe comorbidities that in the opinion of the Investigator might hamper the

participation to the study and/or the treatment administration;

- Any psychological, familial, sociological or geographical condition potentially

hampering compliance with the study protocol and follow-up schedule; those conditions

should be discussed with the patient before registration in the trial;

Studien-Rationale

Primary outcome:

1. Progression Free Survival Rate (PFSR) at month 6 (Time Frame - The Progression Free Survival Rate (PFSR) analysis will be performed at month 6)



Secondary outcome:

1. Progression Free Survival (PFS) (Time Frame - 32 months after first patient in)

2. Overall Survival (OS) (Time Frame - 32 months after first patient in)

3. Toxicity according CTCAE version 4.03 (Time Frame - 32 months after first patient in):
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, for adverse event reporting.

4. Overall Response Rate (ORR) (Time Frame - 32 months after first patient in):
Overall Response Rate (ORR) will be measured according to RECIST 1.1

5. Disease Control Rate (DCR) (Time Frame - 32 months after first patient in)

6. Duration of response (Time Frame - 32 months after first patient in)

Geprüfte Regime

  • Nivolumab (BMS-936558-01):
    Patients will be centrally registered and will receive nivolumab 240 mg IV every 2 weeks

Quelle: ClinicalTrials.gov


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