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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05608291




Registration number
NCT05608291
Ethics application status
Date submitted
14/10/2022
Date registered
8/11/2022

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2022-501576-25-00
Secondary ID [2] 0 0
R3767-ONC-2055
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fianlimab
Treatment: Drugs - Cemiplimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Placebo

Experimental: Fianlimab HD + Cemiplimab - Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab

Experimental: Fianlimab LD + Cemiplimab - Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab

Active comparator: Pembrolizumab - Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo


Treatment: Drugs: Fianlimab
Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks

Treatment: Drugs: Cemiplimab
Cemiplimab will be administered by IV infusion Q 3 weeks

Treatment: Drugs: Pembrolizumab
Pembrolizumab will be administered by IV infusion Q 3 weeks

Treatment: Drugs: Placebo
Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relapse free survival (RSF)
Timepoint [1] 0 0
Up to 5 Years
Secondary outcome [1] 0 0
Distant metastasis-free survival (DMFS)
Timepoint [1] 0 0
Up to 5 Years
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
Up to 5 Years
Secondary outcome [3] 0 0
Occurrence of treatment-emergent adverse events (TEAEs)
Timepoint [3] 0 0
Up to 5 Years
Secondary outcome [4] 0 0
Occurrence of immune-mediated EAEs (im-EAEs)
Timepoint [4] 0 0
Up to 5 Years
Secondary outcome [5] 0 0
Occurrence of serious adverse events (SAEs)
Timepoint [5] 0 0
Up to 5 Years
Secondary outcome [6] 0 0
Occurrence of adverse events of special interest (AESIs)
Timepoint [6] 0 0
Up to 5 Years
Secondary outcome [7] 0 0
Occurrence of TEAEs resulting in death
Timepoint [7] 0 0
Up to 5 Years
Secondary outcome [8] 0 0
Occurrence of dose-limiting toxicity (DLT)
Timepoint [8] 0 0
Up to 5 Years
Secondary outcome [9] 0 0
Occurrence of interruption or discontinuation of study drug(s) due to TEAE
Timepoint [9] 0 0
Up to 5 Years
Secondary outcome [10] 0 0
Occurrence of laboratory abnormalities
Timepoint [10] 0 0
Up to 5 Years
Secondary outcome [11] 0 0
Concentrations of fianlimab in serum over time
Timepoint [11] 0 0
Up to 5 Years
Secondary outcome [12] 0 0
Concentrations of cemiplimab in serum over time
Timepoint [12] 0 0
Up to 5 Years
Secondary outcome [13] 0 0
Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies
Timepoint [13] 0 0
Up to 5 Years
Secondary outcome [14] 0 0
Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies
Timepoint [14] 0 0
Up to 5 Years
Secondary outcome [15] 0 0
Patient report outcomes (PRO) for adults as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Timepoint [15] 0 0
Up to 5 Year
Secondary outcome [16] 0 0
PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L)
Timepoint [16] 0 0
Up to 5 Years
Secondary outcome [17] 0 0
PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma
Timepoint [17] 0 0
Up to 5 Years
Secondary outcome [18] 0 0
PRO for adults as determined by the Patient Global Impressions Scale (PGIS)
Timepoint [18] 0 0
Up to 5 Years
Secondary outcome [19] 0 0
PRO for adults as determined by the Patient Global Impressions of Change Scale (PGIC)
Timepoint [19] 0 0
Up to 5 Years
Secondary outcome [20] 0 0
Time to global health status/quality of life deterioration per EORTC QLQ-C30
Timepoint [20] 0 0
Up to 5 years
Secondary outcome [21] 0 0
Time to physical functioning deterioration per EORTC QLQ-C30
Timepoint [21] 0 0
Up to 5 Years
Secondary outcome [22] 0 0
Time to role functioning deterioration per EORTC QLQ-C30
Timepoint [22] 0 0
Up to 5 Years

Eligibility
Key inclusion criteria
Key

1. 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
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

Key
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 treatment
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. Participants with a history of myocarditis
7. Adolescent patients (=12 to <18 years old) with body weight <40 kg

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/02/2030
Actual
Sample size
Target
1530
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [2] 0 0
Liverpool Hospital (Cancer Therapy Pharmacy) - Liverpool
Recruitment hospital [3] 0 0
Calvary North Adelaid Hospital (HPS Pharmacies) - Adelaide
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Andrew Love Cancer Centre, University Hospital Geelong - Geelong
Recruitment hospital [7] 0 0
Alfred Health - Melbourne
Recruitment hospital [8] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
5006 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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Florida
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United States of America
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Illinois
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Massachusetts
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New Jersey
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New York
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North Carolina
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Ohio
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United States of America
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Rio Negro
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Santa Fe
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Argentina
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Tacuman Province
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East Flanders
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New Brunswick
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Ontario
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Chile
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Metropolitana De Santiago
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Santiago Region Metropolitana De Santiago
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Chile
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Valparaiso
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Bohemia
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Grenoble
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Ile-de-France
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Normandy
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Occitanie Region
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Pays De La Loire Région
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Sarthe
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Rouen
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South Caucasus
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Germany
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Baden-Wurttemberg
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Bavaria
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Hessen
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Lower Saxony
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Mecklenburg Vorpommern
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North Rhine-Westphalia
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Germany
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Rhindeland Palatinate
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Germany
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Sachsen-Anhalt
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Saxony
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Schleswig-Holstein
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Berlin
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Bochum
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Bremen
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Erfurt
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Essen
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Regensburg
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Pireas
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Pylaia
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Connacht
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Northern District
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Jerusalem
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Abruzzo
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Italy
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Campania
Country [87] 0 0
Italy
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Friuli-Venezia Giulia
Country [88] 0 0
Italy
State/province [88] 0 0
Lazio
Country [89] 0 0
Italy
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Lombardy
Country [90] 0 0
Italy
State/province [90] 0 0
Metropolitan City Of Bari
Country [91] 0 0
Italy
State/province [91] 0 0
Milano
Country [92] 0 0
Italy
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Piedmont
Country [93] 0 0
Italy
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Rome Province
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Italy
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Umbria
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Italy
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Veneto
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Italy
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Novara
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Italy
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Taormina
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Italy
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Torrette
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Italy
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Trento
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Mexico
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Sinaloa
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Mexico
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Yucatan
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Mexico
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Veracruz
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Poland
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Mazowieckie
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Pomeria
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Poland
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Pomorskie
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Romania
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Dolj
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Floresti
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Moldava
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Timis
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Transylvania
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Romania
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Bucharest
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South Africa
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Gauteng
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South Africa
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Western Cape
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Spain
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Andalucia
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Spain
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Asturias
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Spain
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Cantabria
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Spain
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Catalonia
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Spain
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Madrid Provincia
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Spain
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Badalona
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Spain
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Granada
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Valencia
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Turkey
State/province [127] 0 0
Anatolia
Country [128] 0 0
Turkey
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Ankara
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Turkey
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Central Anatolia
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Turkey
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Cilicia
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Turkey
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Diyarbakir Province
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Turkey
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Edime
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Turkey
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Gaziantep
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Turkey
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Istanbul Province
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Turkey
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Istanbul
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Turkey
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Izmir Province
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Turkey
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Kocaeli
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Devon
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United Kingdom
State/province [139] 0 0
London
Country [140] 0 0
United Kingdom
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Lothian
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United Kingdom
State/province [141] 0 0
Somerset
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Available to whom?
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05608291