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Thymoma Type B3Phase 2NIVOTHYMNCT03134118

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

A Phase 2 study testing Nivolumab in people with Thymoma Type B3 and Thymic Carcinoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 20 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thymoma Type B3, Thymic Carcinoma
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
20 sitesin 6 countries
Study dates
11 Apr 2018to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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;

Trial locations and contacts

20 sites in 6 countries.

20 sites in 6 countries

France8 sites

  • CHU de Brest

    Brest, 29200

  • CHU de Lyon - Hopital Louis Pradel

    Bron, 69500

  • Centre Francois Baclesse

    Caen, 14076

  • CHU de Grenoble - La Tronche - Hôpital A. Michallon

    La Tronche, 38700

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

    Marseille

  • Institut Curie- Hopital de Paris

    Paris, 75248

  • CHU Toulouse - Hopital Larrey

    Toulouse, 31059

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

United Kingdom4 sites

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

    Glasgow

  • Royal Marsden Hospital - Chelsea, London

    London

  • Royal Marsden Hospital - Sutton, Surrey

    Sutton

  • The Christie NHS Foundation Trust

    Wythenshawe, M23 9LT

Other trials in United Kingdom

Netherlands3 sites

  • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

    Amsterdam, 1066

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

Belgium2 sites

  • Institut Jules Bordet

    Brussels

  • Universitair Ziekenhuis Antwerpen (UZA)

    Edegem

Other trials in Belgium

Spain2 sites

  • Vall d'Hebron Institut d'Oncologia

    Barcelona

  • Hospital Universitario 12 De Octubre

    Madrid

Other trials in Spain

Switzerland1 site

  • UniversitaetsSpital Zurich

    Zurich

Other trials in Switzerland

About this study

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

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.

Being tested
Nivolumab
Keywords
Thymoma, Phase II, nivolumab, Thymic carcinoma
Medical subject headings
Thymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called BMS-936558-01

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

Study groups in NCT03134118
Study groupRoleWhat they receive
NivolumabExperimentalPatients will be centrally registered and will receive nivolumab 240 mg IV every 2 weeks
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival Rate (PFSR) at month 6

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

Secondary outcomes (6)

  1. Progression Free Survival (PFS)

    Measured: 32 months after first patient in

  2. Overall Survival (OS)

    Measured: 32 months after first patient in

  3. Toxicity according CTCAE version 4.03

    This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, for adverse event reporting.

    Measured: 32 months after first patient in

  4. Overall Response Rate (ORR)

    Overall Response Rate (ORR) will be measured according to RECIST 1.1

    Measured: 32 months after first patient in

  5. Disease Control Rate (DCR)

    Measured: 32 months after first patient in

  6. Duration of response

    Measured: 32 months after first patient in

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2017
  2. Study start11 Apr 2018
  3. Primary completion5 Sep 2023
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03134118
Sponsor's protocol ID
EORTC-1525
Other IDs
2015-005504-28, ETOP 11-16, 2015
Acronym
NIVOTHYM
Status last verified
May 2026
First submitted
26 Apr 2017
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34393061

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Thymoma Type B3 and Thymic Carcinoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 20 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France, United Kingdom, Netherlands, Belgium, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival Rate (PFSR) at month 6 (time frame: The Progression Free Survival Rate (PFSR) analysis will be performed at month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03134118, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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