NCT03405155

Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by Surgery

Phase II Study of Adjuvant Nivolumab in Patients With Resected Stage IIB/IIC Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well nivolumab works in treating patients with stage IIB-IIC melanoma that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. To assess the efficacy nivolumab administered in the adjuvant setting in patients with resected stage IIB or stage IIC cutaneous melanoma. SECONDARY OBJECTIVES: I. To evaluate and estimate the median duration of overall survival (OS) in stage IIB-IIC melanoma patients. II. To evaluate and estimate the median duration of distant metastases-free survival (DMFS) in stage IIB-IIC melanoma patients. III. To assess safety and toxicity using Common Terminology Criteria for Adverse Events (CTCAE) version (V)5. IV. To assess quality of life using the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life instrument. TERTIARY OBJECTIVES: I. To assess and compare clinical, histological, immunological and molecular panels as prognostic and predictive biomarkers.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2018-01-17
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2018-01-19
• Last updated: 2025-12-31

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study