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

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ClinicalTrials.gov Identifier: NCT03132038
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Brief 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.


Condition or disease Intervention/treatment Phase
Salivary Gland Carcinoma Metastatic Cancer Recurrent Cancer Drug: Nivolumab Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab
Nivolumab will be given every two weeks for a maximum of one year (12 cycles) at a dose of 3mg/kg to be administered as a 60 minute IV infusion
Drug: Nivolumab
3mg/kg, every two weeks, during a maximum of one year
Other Name: Opdivo




Primary Outcome Measures :
  1. non-progression rate [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. progression free survival (PFS) [ Time Frame: the time from the date of first Nivolumab administration until the date of event, assessed up to 84 months. ]
    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)

  2. Overall survival [ Time Frame: the time from the date of first dose until the date of death due to any cause, assessed up to 84 months. ]
    the time from the date of first dose until the date of death due to any cause

  3. Objective response rate (ORR) [ Time Frame: 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 ]
    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).

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: the time from the date of first dose until the end of treatment, assessed up to 84 months. ]
    incidence of all adverse events, serious adverse events, deaths and laboratory abnormalities

  5. quality of life [ Time Frame: the time from the date of first dose until the end of treatment, assessed up to 84 months. ]
    Quality of Life will be assessed using the EORTC QLQ-C30 and QLQ-H&N35 questionnaires.

  6. Biomarkers (central PD-L1 assessment, PD-L2, TILs) [ Time Frame: after 2 months of treatment and at the end of treatment, assessed up to 12 months. ]
    Correlations between expression of molecular targets and efficacy

  7. Growth Tumor rate [ Time Frame: At each disease evaluation from baseline to last imagery, assessed up to 84 months. ]
    The growth tumor rate will be assessed using RECIST 1.1 criteria before and under treatment for all eligible patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 1.1 criteria with MRI or 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.
  • Performance status ECOG < 2 (Eastern Cooperative Oncology Group)
  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132038


Contacts
Contact: Jessy DELAYE 33 (0)144235577 j-delaye@unicancer.fr

Locations
France
CHU Bordeaux Not yet recruiting
Bordeaux, France, 33075
Principal Investigator: Laurence DIGUE, MD         
Centre Georges François Leclerc Not yet recruiting
Dijon, France, 21079
Principal Investigator: Nicolas ISAMBERT, MD         
Centre Léon Bérard Recruiting
Lyon, France, 69437
Principal Investigator: Jérôme FAYETTE, MD         
ICM Val d'Aurelle Not yet recruiting
Montpellier, France, 34298
Principal Investigator: Didier CUPISSOL, MD         
Centre Antoine Lacassagne Not yet recruiting
Nice, France, 06189
Principal Investigator: Joel GUIGAY, MD PhD         
Institut Curie Not yet recruiting
Paris, France
Principal Investigator: Christophe LE TOURNEAU, MD         
Centre Eugene Marquis Not yet recruiting
Rennes, France, 35042
Principal Investigator: Brigitte LAGUERRE, MD         
Institut Curie Saint Cloud Not yet recruiting
Saint Cloud, France, 92210
Principal Investigator: Laurence BOZEC LE MOAL, MD         
Centre René Gauducheau Not yet recruiting
Saint-Herblain, France, 44805
Principal Investigator: Frédéric ROLLAND, Md         
Centre Paul Strauss Not yet recruiting
Strasbourg, France, 67000
Principal Investigator: Christian BOREL, MS         
Institut de cancérologie Alexis Vautrin Not yet recruiting
Vandoeuvre les Nancy, France, 54519
Principal Investigator: Marie-Christine KAMINSKY, MD         
Gustave Roussy Not yet recruiting
Villejuif, France, 94800
Principal Investigator: Caroline EVEN, MD         
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Jérôme FAYETTE, MD Léon Bérard Center

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03132038     History of Changes
Other Study ID Numbers: UC-0130/1619
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no individual participant data is shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasm Metastasis
Salivary Gland Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Carcinoma
Recurrence
Neoplastic Processes
Pathologic Processes
Disease Attributes
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs