A trial to see if the combination of fianlimab with cemiplimab works better than pembrolizumab for preventing or delaying melanoma from coming back after it has been removed with surgery

Phase 1

Recruiting

• Conditions: Melanoma; MedDRA version: 21.1Level: PTClassification code: 10025650Term: Malignant melanoma Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-501576-25-00
• Lead Sponsor: Regeneron Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1530

Inclusion Criteria

All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition according to cutaneous melanoma staging criteria and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol, Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery, All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol

Exclusion Criteria

Uveal melanoma, Any evidence of residual disease after surgery by imaging, pathology, or cytology, Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment, Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol, Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol, Adolescent patients (=12 to <18 years old) with body weight <40 kg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified