Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objective of the study is To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS)

The secondary objectives of the study are:

  • To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by overall survival (OS)
  • To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by melanoma specific survival (MSS)
  • To evaluate whether post-operative adjuvant therapy improves distant metastasis-free survival (DMFS), in stage IIC or III patients receiving fianlimab + cemiplimab compared to pembrolizumab
  • To assess impact of fianlimab + cemiplimab on quality of life as compared to pembrolizumab in adults
  • To assess safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab
  • To characterize pharmacokinetics (PK) of fianlimab + cemiplimab using sparse PK sampling in patients 12 years of age and older
  • To assess immunogenicity of fianlimab and against cemiplimab

Official Title

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

Keywords

Melanoma, Resected High Risk Melanoma, Skin Cancer, Stage IIC, Stage III, Stage IV, LAG-3 Lymphocyte activation gene 3, Adjuvant Setting, anti-PD-1 Monoclonal Antibody, Pembrolizumab, Cemiplimab, Fianlimab, Fianlimab HD + Cemiplimab, Fianlimab LD + Cemiplimab

Eligibility

You can join if…

Open to people ages 12 years and up

  1. All patients must be either stage 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
  2. Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
  3. 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

You CAN'T join if...

  1. Uveal melanoma
  2. Any evidence of residual disease after surgery by imaging, pathology, or cytology.
  3. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required systemic treatment with immunosuppressive agents
  4. 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
  5. Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
  6. Adolescent patients (≥12 to <18 years old) with body weight <40 kg

    Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • John Wayne Cancer Institute - Saint John's Health Center accepting new patients
    Santa Monica California 90404-2312 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT05608291
Phase
Phase 3 Skin Cancer/Melanoma Research Study
Study Type
Interventional
Participants
Expecting 1530 study participants
Last Updated