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
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)|
|Estimated Enrollment :||92 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|
|Estimated Primary Completion Date :||September 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 [ 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.
- 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
- 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
|Contact: Jessy DELAYE||33 (0)firstname.lastname@example.org|
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