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Salivary Gland CarcinomaPhase 2NISCAHNNCT03132038

Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck

A Phase 2 study testing Nivolumab in people with Salivary Gland Carcinoma and Metastatic Cancer, run by UNICANCER at 11 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

INDICATION: Patients with recurrent and/or metastatic salivary glands carcinoma who have progressed during the 6 months period before entering the study and who are eligible for nivolumab monotherapy. Read more about this study

Who is it for?
Ages 18 years and older
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
98 participants
Where
11 sitesFrance
Study dates
24 Mar 2017to 20 Oct 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Adult men and women ≥18 years
  • Histologically confirmed carcinoma of the salivary glands, recurrent or metastatic (adenoid cystic carcinoma or non-adenoid cystic carcinoma) not eligible to local treatment
  • Pre-treatment tumor tissue available for central review and biomarkers analysis.
  • At least one measurable lesion ≥10 mm (outside any previous irradiated field) according to RECIST v1.1 with magnetic resonance imaging (MRI) or computed tomography (CT)-scan
  • Patients with confirmed disease progression at study entry. The "baseline" radiological evaluation (either MRI or CT scan) should demonstrate disease progression by RECIST 1.1 when compared to a prior disease assessment done within a 6 months period prior to screening
  • Previous anti-cancer therapies must be discontinued at least 4 weeks prior to administration of study drug. Concomitant, palliative (limited-field) radiation therapy is permitted during the study, if all of the following criteria are met: (1) repeated imaging demonstrates no new sites of bone metastases ; (2) The lesion being considered for palliative radiation is not a target lesion
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  • Performance status Eastern Cooperative Oncology Group (ECOG) <2
  • Screening laboratory values must meet the following criteria and should be obtained within 7 days prior to starting study drug: White Blood Cell (WBC) ≥2000/mm³, Neutrophils ≥1500/mm³, Platelets ≥100 000 /mm³, Hemoglobin >9.0 g/dL, Serum creatinine ≤1.5 x Upper Limit of Normal (ULN) or creatinine clearance (CrCl) ≥40 mL/min (using the Cockcroft-Gault formula), aspartate transaminase (AST) / alanine transaminase (ALT) / alkaline phosphatase (PAL) ≤3 x ULN or ≤5 x ULN when liver metastases, Total Bilirubin ≤1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin <3.0 mg/dL)
  • Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab
  • Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception)
  • Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
  • Patients with social insurance coverage

Who cannot join

  • Stable disease
  • Symptomatic / active brain metastases
  • Immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone equivalents) within 2 weeks prior to study drug administration. A 2 weeks wash-out minimum is required before starting study drug
  • Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
  • Patients with any active or suspected autoimmune disease or an history of known autoimmune disease (Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are however eligible for this trial)
  • Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
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  • History of organ transplantation requiring long-term immunosuppressive medications
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
  • Known history or active tuberculosis
  • Any other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured in situ cancer) unless free of disease for at least three years
  • History of allergy to study drug components
  • Any toxicity (other than alopecia) attributed to prior anti-cancer therapy not resolved to grade 1 (NCI CTCAE version 4) at baseline level before administration of study drug.
  • Known or underlying medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events
  • History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake (if applicable)
  • Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study
  • Individuals deprived of liberty or placed under the authority of a tutor
  • Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment and during the treatment period

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • CHU Bordeaux

    Bordeaux, 33075

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Léon Bérard

    Lyon, 69437

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie

    Paris

  • Institut Curie Saint Cloud

    Saint-Cloud, 92210

  • Centre René Gauducheau

    Saint-Herblain, 44805

  • Centre Paul Strauss

    Strasbourg, 67000

  • Institut de cancérologie Alexis Vautrin

    Vandœuvre-lès-Nancy, 54519

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: A Phase II, Multicenter, Non Randomized, Open Label Study of Nivolumab In Recurrent and/or Metastatic Salivary Gland Carcinoma of the Head and Neck

INDICATION:

Patients with recurrent and/or metastatic salivary glands carcinoma who have progressed during the 6 months period before entering the study and who are eligible for nivolumab monotherapy.

Read the detailed description

METHODOLOGY:

The present study is a multicenter, open-label, non-controlled, phase II study in patients who are suffering from recurrent and/or metastatic Salivary Glands Carcinoma, who have progressed during the 6 months period before entering the study and who are eligible for nivolumab monotherapy.

All eligible patients will receive nivolumab treatment for a maximum of 12 cycles of treatment. 92 eligible patients will be dosed with nivolumab intravenously over 60 minutes (± 5 minutes) at 3 mg/kg every two weeks.

Each 28-day dosing period will constitute a cycle.

Being tested
Nivolumab
Medical subject headings
Salivary Gland Neoplasms, Neoplasm Metastasis, Recurrence

What participants receive

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

  • NivolumabDrug

    Also called Opdivo

    3 mg/kg, every two weeks, during a maximum of one year

Study groups in NCT03132038
Study groupRoleWhat they receive
NivolumabExperimentalNivolumab will be given every two weeks for a maximum of one year (12 cycles) at a dose of 3 mg/kg to be administered as a 60 minute IV infusion
Receives: Drug: Nivolumab

What is being measured

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

  1. non-progression rate

    The proportion of patients with a complete response (CR) or a partial response (PR) or a stable disease (SD) as per RECIST 1.1 after 6 months of treatment.

    Measured: 6 months

Secondary outcomes (8)

  1. progression free survival (PFS)

    the time from the date of first Nivolumab administration until the date of event defined as the first progression according to RECIST 1.1, or death (by any cause in the absence of progression)

    Measured: the time from the date of first Nivolumab administration until the date of event, assessed up to 84 months.

  2. Overall survival

    the time from the date of first dose until the date of death due to any cause

    Measured: the time from the date of first dose until the date of death due to any cause, assessed up to 84 months.

  3. Objective response rate (ORR)

    ORR is defined as the number and percentage of patients with a Best Overall Response (BOR) of confirmed complete response (CR) or partial response (PR).

    Measured: the time from the date of first dose until the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, assessed up to 84 months

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    incidence of all adverse events, serious adverse events, deaths and laboratory abnormalities

    Measured: the time from the date of first dose until the end of treatment, assessed up to 84 months.

  5. Quality of life questionnaire - Core 30 (QLQ-C30)

    Developed by the European Organisation for Research and Treatment of Cancer (EORTC), this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

    The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: the time from the date of first dose until the end of treatment, assessed up to 84 months.

  6. Quality of Life Questionnaire - Head & Neck Cancer Module (QLQ-H&N35)

    This EORTC head \& neck cancer specific questionnaire is intended to supplement the QLQ-C30.

    The head \& neck cancer module is a 35-item questionnaire designed for use among a wide range of patients with head \& neck cancer, varying in disease stage and treatment modality. It includes 7 multi-item scales that assess pain (4 items), swallowing (4 items), senses (2 items), speech (3 items), social eating (4 items), social contact (5 items), and sexuality (2 items). There are also 11 single items. Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms. For all items and scales, high scores indicate more problems.

    Measured: The time from the date of first dose until the end of treatment, assessed up to 84 months.

  7. Biomarkers (central PD-L1 assessment, PD-L2, tumor-infiltrating lymphocyte (TILs))

    Correlations between expression of molecular targets and efficacy

    Measured: after 2 months of treatment and at the end of treatment, assessed up to 12 months.

  8. Growth Tumor rate

    The growth tumor rate will be assessed using RECIST 1.1 criteria before and under treatment for all eligible patients.

    Measured: At each disease evaluation from baseline to last imagery, assessed up to 84 months.

Timeline

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

  1. First posted27 Apr 2017
  2. Study start24 Mar 2017
  3. Primary completion1 Jan 2019
  4. Study completion20 Oct 2021

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
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03132038
Sponsor's protocol ID
UC-0130/1619
Other IDs
2016-001794-32, 2016
Acronym
NISCAHN
Status last verified
Jan 2022
First submitted
19 Apr 2017
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: no individual participant data is shared

Publications

  • Fayette J, Even C, Digue L, Geoffrois L, Rolland F, Cupissol D, Guigay J, Le Tourneau C, Dillies AF, Zanetta S, Bozec L, Borel C, Couchon-Thaunat S, Costes-Martineau V, Sudaka-Bahadoran A, Jallut I, Garic F, Lardy-Cleaud A, Chabaud S. NISCAHN: a phase II trial of nivolumab in patients with salivary gland carcinoma (Unicancer ORL-08). BMJ Oncol. 2023 Oct 30;2(1):e000065. doi: 10.1136/bmjonc-2023-000065. eCollection 2023.

    PubMed 39886516

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Salivary Gland Carcinoma and Metastatic Cancer, run by UNICANCER at 11 sites in France.

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 14 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: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

non-progression rate (time frame: 6 months). 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 NCT03132038, 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 11 Jan 2022.

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