NCT03758729

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a phase II, single-arm, single-center study to evaluate the response rate, efficacy and safety of nivolumab in combination with radiation therapy in subjects with of locally advanced, unresectable head and neck mucosal melanoma. A cycle is defined as 14 days. The nivolumab dose will be fixed at the recommended phase II dose of 3mg/kg as a 60-minute IV infusion every two weeks. Patients will continue on nivolumab up to 8 weeks, until disease progression, unacceptable toxicity, investigator's decision to remove patient from the study, patient refusal to continue, or alternative treatment. Concurrent radiotherapy of 70Gy for 6-7 weeks will be initiated on the same day of first nivolumab dose of cycle 1. The combination of 70 Gy radiotherapy for 6-7 weeks begins on the day of initial administration of nivolumab, radiation therapy dose and treatment schedule 2.0, based on NCFC practice. Nivolumab is administered every two weeks in in combination with radiation therapy and has elapsed since 8 weeks (after 4 cycles) The administration of clinical trials in is terminated but nivolumabs is sustainable at the discretion of investigator. (This is carried out independently of the clinical trial) The response rate of radiation therapy is assessed by performing a tumor assessment every two months up to the end of radiation therapy.

Conditions

• Melanoma

Interventions

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

Timeline

• Start date: 2020-05-01
• Primary completion: 2020-05-01
• Completion: 2020-05-11
• First posted: 2018-11-29
• Last updated: 2021-02-16