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

Sponsor
UNICANCER
Study ID
NCT03132038
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Cancer
  • Recurrent Cancer
  • Salivary Gland Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    3 mg/kg, every two weeks, during a maximum of one year

Study Details

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.

Key Dates

Start date
Mar 24, 2017
Status verified
Jan 2022
Primary completion
Jan 1, 2019
Completion
Oct 20, 2021

Study Design

Enrollment
98 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab 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

Primary Outcome Measure

non-progression rate [ Time Frame: 6 months ]

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