Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck (NISCAHN)
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|ClinicalTrials.gov Identifier: NCT03132038|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : October 29, 2019
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|
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)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||January 1, 2019|
|Estimated Study Completion Date :||March 2024|
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
3mg/kg, every two weeks, during a maximum of one year
Other Name: Opdivo
- 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.
- 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)
- 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
- 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).
- 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
- Quality of life questionnaire - Core 30 (QLQ-C30) [ Time Frame: the time from the date of first dose until the end of treatment, assessed up to 84 months. ]
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.
- Quality of Life Questionnaire - Head & Neck Cancer Module (QLQ-H&N35) [ Time Frame: The time from the date of first dose until the end of treatment, assessed up to 84 months. ]
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.
- Biomarkers (central PD-L1 assessment, PD-L2, tumor-infiltrating lymphocyte (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
- 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.
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
|Bordeaux, France, 33075|
|Centre Georges François Leclerc|
|Dijon, France, 21079|
|Centre Léon Bérard|
|Lyon, France, 69437|
|ICM Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Institut Curie Saint Cloud|
|Saint Cloud, France, 92210|
|Centre René Gauducheau|
|Saint-Herblain, France, 44805|
|Centre Paul Strauss|
|Strasbourg, France, 67000|
|Institut de cancérologie Alexis Vautrin|
|Vandoeuvre les Nancy, France, 54519|
|Villejuif, France, 94800|
|Principal Investigator:||Jérôme FAYETTE, MD||Léon Bérard Center|