A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objective:

To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by RFS.

Secondary Objectives:

To evaluate whether post-operative adjuvant therapy improves DMFS, in stage IIB, IIC, or III patients receiving fianlimab + cemiplimab compared to pembrolizumab.
To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by OS.
To assess safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab.
To characterize PK of fianlimab + cemiplimab using sparse PK sampling in patients 12 years of age and older.
To assess immunogenicity of fianlimab and against cemiplimab.
To assess impact of fianlimab + cemiplimab on quality of life as compared to pembrolizumab in adults.

Eligibility

Inclusion Criteria:

All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition 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
Participants with a history of myocarditis
Adolescent patients (≥12 to <18 years old) with body weight <40 kg

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices