Phase II Study of Nivolumab in Combination With Radiation Therapy as Definitive Treatment for Patients With Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.

Sponsor
Samsung Medical Center
Study ID
NCT03758729
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 3mg/kg + NS 100mL MIV over 1hr every 2 weeks
  • Radiation Therapy — RADIATION
    Radiation Therapy

Study Details

This is a Phase 2, single center study to evaluate the efficacy, safety of nivolumab in combination with radiation therapy in patients with mucosal melanoma of the head and neck (MMHN). Target Accrual and Study duration We will accrue up to 26 patients. It is estimated to take up to 2 years. The sample size is calculated by use of SWOG CRAB (Cancer Research And Biostatistics) to control the type I error at 5 % for null hypothesis that the true response rate was 25 % or below and to have 80 % of power if the true response rate was 50 % or higher. Although the target number of evaluable patients is 23, we planned to recruit 10% more than the target number of patients considering dropout, total 26.

Key Dates

Start date
May 31, 2020
Status verified
Feb 2021
Primary completion
May 31, 2020
Completion
May 11, 2020

Study Design

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

Arms

  • Experimental: Nivolumab
    Nivolumab 3mg/kg + NS 100mL MIV over 1hr every 2 weeks

Primary Outcome Measure

Response rate [ Time Frame: 2 years ]

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