Pembrolizumab for Melanoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Orlando Health, Inc, Orlando, FL
Melanoma
Pembrolizumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS) The secondary objectives of the study are: To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component To assess immunogenicity of fianlimab and cemiplimab To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults To characterize safety and tolerability of treatment in patients 12 to <18 years of age To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Melanoma

Study Objectives

1 Primary · 26 Secondary · Reporting Duration: Up to 6 years

Approximately 27 months
Progression-free survival (PFS)
Baseline to Week 25
Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30
Year 6
Change in GHS/QoL per EORTC QLQ-C30
Change in physical functioning per EORTC QLQ-C30
Change in role functioning per EORTC QLQ-C30
Year 6
PROs as measured by Patient Global Impression of Change (PGIC)
PROs as measured by Patient Global Impression of Severity (PGIS)
Up to 27 months
Disease control rate (DCR)
Duration of response (DoR)
Objective response rate (ORR)
PFS
Year 6
Incidence of ADA to cemiplimab over time
Incidence of NAb to cemiplimab over time
Incidence of anti-drug antibodies (ADA) to fianlimab over time
Incidence of neutralizing antibodies (NAb) to fianlimab over time
Titer of ADA to cemiplimab over time
Titer of anti-drug antibodies (ADA) to fianlimab over time
Up to 6 years
Incidence of deaths
Year 6
Concentrations of cemiplimab in serum
Concentrations of fianlimab in serum
Incidence of Adverse Events (AEs)
Incidence of laboratory abnormalities
Occurrence of interruption and discontinuation of study drug(s) due to AEs
PROs as measured by EQ-5D-5L
PROs as measured by Functional Assessment of Cancer Therapy (FACT)-melanoma (melanoma subscale only)
Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
Up to 96 months
Overall survival (OS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Melanoma

Trial Design

5 Treatment Groups

A1: fianlimab+cemiplimab dose 2
1 of 5
A: fianlimab+cemiplimab dose 1
1 of 5
C: cemiplimab+placebo
1 of 5
B: pembrolizumab+placebo
1 of 5
A: fianlimab+cemiplimab
1 of 5
Experimental Treatment

1590 Total Participants · 5 Treatment Groups

Primary Treatment: Pembrolizumab · Has Placebo Group · Phase 3

A1: fianlimab+cemiplimab dose 2Experimental Group · 2 Interventions: Cemiplimab, Fianlimab · Intervention Types: Drug, Drug
A: fianlimab+cemiplimab dose 1Experimental Group · 2 Interventions: Cemiplimab, Fianlimab · Intervention Types: Drug, Drug
C: cemiplimab+placeboExperimental Group · 2 Interventions: Cemiplimab, Placebo · Intervention Types: Drug, Drug
B: pembrolizumab+placeboExperimental Group · 2 Interventions: Placebo, Pembrolizumab · Intervention Types: Drug, Drug
A: fianlimab+cemiplimabExperimental Group · 2 Interventions: Cemiplimab, Fianlimab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 1
~400
Placebo
1995
Completed Phase 3
~2670
Pembrolizumab
2017
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 years
Closest Location: Orlando Health, Inc · Orlando, FL
Photo of Orlando 1Photo of Orlando 2Photo of Orlando 3
2015First Recorded Clinical Trial
7 TrialsResearching Melanoma
14 CompletedClinical Trials

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
535 Previous Clinical Trials
193,995 Total Patients Enrolled
8 Trials studying Melanoma
708 Patients Enrolled for Melanoma
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
217 Previous Clinical Trials
84,766 Total Patients Enrolled
1 Trials studying Melanoma
47 Patients Enrolled for Melanoma

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 12 years of age or older.
Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease are eligible for this study.
Patients with acral and mucosal melanomas are eligible.
The presence of a previously irradiated lesion does not preclude the need for further treatment.
For adult patients: PS 0 or 1.
For pediatric patients: You are aged 16 years or older.
You have a life expectancy of at least 3 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.