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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05352672




Registration number
NCT05352672
Ethics application status
Date submitted
6/04/2022
Date registered
29/04/2022
Date last updated
22/02/2024

Titles & IDs
Public title
Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Scientific title
A Phase 2 and Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Secondary ID [1] 0 0
2021-004453-23
Secondary ID [2] 0 0
R3767-ONC-2011
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: A: fianlimab+cemiplimab dose 1 - Phase 2 and Phase 3

Experimental: A1: fianlimab+cemiplimab dose 2 - Phase 2 and Phase 3 (except for PA1 patients as described in the protocol)

Experimental: B: pembrolizumab+placebo - Phase 2 and Phase 3

Experimental: C: cemiplimab+placebo - Phase 2 (as described in the protocol)


Treatment: Drugs: Fianlimab
Intravenous (IV) infusion

Treatment: Drugs: Cemiplimab
IV infusion

Treatment: Drugs: Pembrolizumab
IV infusion

Treatment: Drugs: Placebo
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Approximately 27 months
Primary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
Approximately 27 months
Secondary outcome [1] 0 0
PFS
Timepoint [1] 0 0
Up to 27 months
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
Up to 96 months
Secondary outcome [3] 0 0
ORR
Timepoint [3] 0 0
Up to 27 months
Secondary outcome [4] 0 0
Disease control rate (DCR)
Timepoint [4] 0 0
Up to 27 months
Secondary outcome [5] 0 0
Duration of response (DoR)
Timepoint [5] 0 0
Up to 27 months
Secondary outcome [6] 0 0
Incidence of Adverse Events (AEs)
Timepoint [6] 0 0
Up to 90 days post last dose, approximately 6 years
Secondary outcome [7] 0 0
Occurrence of interruption and discontinuation of study drug(s) due to AEs
Timepoint [7] 0 0
Up to 90 days post last dose, approximately 6 years
Secondary outcome [8] 0 0
Incidence of deaths related to TEAEs
Timepoint [8] 0 0
Up to 6 years
Secondary outcome [9] 0 0
Incidence of laboratory abnormalities
Timepoint [9] 0 0
Up to 90 days post last dose, approximately 6 years
Secondary outcome [10] 0 0
Concentrations of cemiplimab in serum
Timepoint [10] 0 0
Up to 90 days post last dose, approximately 6 years
Secondary outcome [11] 0 0
Concentrations of fianlimab in serum
Timepoint [11] 0 0
Up to 90 days post last dose, approximately 6 years
Secondary outcome [12] 0 0
Incidence of anti-drug antibodies (ADA) to fianlimab over time
Timepoint [12] 0 0
Up to 30 days post last dose, approximately 6 years
Secondary outcome [13] 0 0
Titer of anti-drug antibodies (ADA) to fianlimab over time
Timepoint [13] 0 0
Up to 30 days post last dose, approximately 6 years
Secondary outcome [14] 0 0
Incidence of ADA to cemiplimab over time
Timepoint [14] 0 0
Up to 30 days post last dose, approximately 6 years
Secondary outcome [15] 0 0
Titer of ADA to cemiplimab over time
Timepoint [15] 0 0
Up to 30 days post last dose, approximately 6 years
Secondary outcome [16] 0 0
Incidence of neutralizing antibodies (NAb) to fianlimab over time
Timepoint [16] 0 0
Up to 30 days post last dose, approximately 6 years
Secondary outcome [17] 0 0
Incidence of NAb to cemiplimab over time
Timepoint [17] 0 0
Up to 30 days post last dose, approximately 6 years
Secondary outcome [18] 0 0
Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
Timepoint [18] 0 0
Up to 90 days post last dose, approximately 6 years
Secondary outcome [19] 0 0
PROs as measured by EQ-5D-5L
Timepoint [19] 0 0
Up to 90 days post last dose, approximately 6 years
Secondary outcome [20] 0 0
PROs as measured by Functional Assessment of Cancer Therapy melanoma (FACTM) (melanoma subscale only)
Timepoint [20] 0 0
Up to 90 days post last dose, approximately 6 years
Secondary outcome [21] 0 0
PROs as measured by Patient Global Impression of Severity (PGIS)
Timepoint [21] 0 0
Up to 21 days post last dose, approximately 6 years
Secondary outcome [22] 0 0
PROs as measured by Patient Global Impression of Change (PGIC)
Timepoint [22] 0 0
Up to 21 days post last dose, approximately 6 years
Secondary outcome [23] 0 0
Change in physical functioning per EORTC QLQ-C30
Timepoint [23] 0 0
Baseline to Week 25
Secondary outcome [24] 0 0
Change in role functioning per EORTC QLQ-C30
Timepoint [24] 0 0
Baseline to Week 25
Secondary outcome [25] 0 0
Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30
Timepoint [25] 0 0
Baseline to Week 25
Secondary outcome [26] 0 0
Change in physical functioning per EORTC QLQ-C30
Timepoint [26] 0 0
Baseline to end of study, approximately 6 years
Secondary outcome [27] 0 0
Change in role functioning per EORTC QLQ-C30
Timepoint [27] 0 0
Baseline to end of study, approximately 6 years
Secondary outcome [28] 0 0
Change in GHS/QoL per EORTC QLQ-C30
Timepoint [28] 0 0
Baseline to end of study, approximately 6 years

Eligibility
Key inclusion criteria
Key

1. Age =12 years on the date of providing informed consent

2. 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

1. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible
if they did not have evidence of progression or recurrence of disease and/or
discontinued due to occurrence of unmanageable imAEs = grade 3 (with the
exclusion of endocrinopathies which are fully controlled by hormone replacement)
while on such therapies. Also, patients must have had a treatment-free and
disease-free interval of >6 months. Accrual of these patients is limited to
approximately 10% of the total population enrolled in each of the Phase 2 and
Phase 3 parts of the study.

2. Patients with acral and mucosal melanomas are eligible. Combined accrual will be
limited to 10% of the total population enrolled in the Phase 3 part of the study.

3. Measurable disease per RECIST v1.1

1. Previously irradiated lesions can only be counted as target lesions if they have
been demonstrated to progress and no other target lesion is available

2. Cutaneous lesions should be evaluated as non-target lesions

4. Performance status:

1. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status
(PS) 0 or 1

2. For pediatric patients: Karnofsky performance status =70 (patients =16 years) or
Lansky performance status =70 (patients =16 years)

5. Anticipated life expectancy of at least 3 months

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. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required
systemic treatment with immunosuppressive agents. The following are non-exclusionary:
vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires
only hormone replacement, psoriasis not requiring systemic treatment.

3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or
hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related
to, or results in chronic infection

4. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as
described in the protocol

5. Systemic immune suppression:

1. Use of immunosuppressive doses of corticosteroids (>10mg of prednisone per day or
equivalent) within 14 days of the first dose of study medication. Physiologic
replacement doses are allowed up to and including 10mg of prednisone/day or
equivalent. Inhaled or topical steroids are permitted, if they are not for
treatment of an autoimmune disorder.

2. Other clinically relevant forms of systemic immune suppression

6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy,
major surgery or biological therapy within 21 days prior to the first dose of trial
treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive
cancers in long term remission is allowed.

7. History or current evidence of significant (CTCAE Grade =2) local or systemic
infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic
treatment within 14 days prior to the first dose of trial medication.

8. Participants with a history of myocarditis.

9. Active or untreated brain metastases or spinal cord compression. Patients with
leptomeningeal disease are excluded. Patients with known brain metastases are eligible
if they:

1. Received radiotherapy or another appropriate standard therapy for the brain
metastases,

2. Have neurologically returned to baseline (except for residual signs and symptoms
related to the CNS treatment) for at least 14 days prior to enrollment

3. Did not require immunosuppressive doses of corticosteroids therapy (>10mg of
prednisone per day or equivalent) in the 14 days prior to enrollment

4. Are asymptomatic with a single untreated brain metastasis <10 mm in size

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 2/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
14/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2032
Actual
Sample size
Target
1925
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Calvary North Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Barwon Health Andrew Love Cancer Centre, University Hospital Geelong - Geelong
Recruitment hospital [3] 0 0
Icon Cancer Centre Hobart - Hobart
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 0 0
The Townsville Hospital and Health Service - Townsville
Recruitment hospital [7] 0 0
Ballarat Oncology and Haematology Clinical Trials Unit - Wendouree
Recruitment postcode(s) [1] 0 0
05006 - Adelaide
Recruitment postcode(s) [2] 0 0
03220 - Geelong
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
03004 - Melbourne
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
04814 - Townsville
Recruitment postcode(s) [7] 0 0
03355 - Wendouree
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
Caba
Country [8] 0 0
Argentina
State/province [8] 0 0
Ciudad Autonoma de Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Rosario
Country [10] 0 0
Argentina
State/province [10] 0 0
San Miguel de Tucuman
Country [11] 0 0
Austria
State/province [11] 0 0
Tyrol
Country [12] 0 0
Austria
State/province [12] 0 0
Graz
Country [13] 0 0
Austria
State/province [13] 0 0
St. Poelten
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Kortrijk
Country [17] 0 0
Belgium
State/province [17] 0 0
Namur
Country [18] 0 0
Belgium
State/province [18] 0 0
Sint Niklaas
Country [19] 0 0
Brazil
State/province [19] 0 0
Barretos
Country [20] 0 0
Brazil
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Belo Horizonte
Country [21] 0 0
Brazil
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Curitiba
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Brazil
State/province [22] 0 0
Ijui
Country [23] 0 0
Brazil
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Itajai
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Brazil
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Joinville
Country [25] 0 0
Brazil
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Lages
Country [26] 0 0
Brazil
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Lajeado
Country [27] 0 0
Brazil
State/province [27] 0 0
Passo Fundo
Country [28] 0 0
Brazil
State/province [28] 0 0
Porto Alegre
Country [29] 0 0
Brazil
State/province [29] 0 0
Porto Velho
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio de Janeiro
Country [31] 0 0
Brazil
State/province [31] 0 0
Salvador
Country [32] 0 0
Brazil
State/province [32] 0 0
Santo Cristo
Country [33] 0 0
Brazil
State/province [33] 0 0
Sao Jose do Rio Preto
Country [34] 0 0
Brazil
State/province [34] 0 0
Sao paulo
Country [35] 0 0
Brazil
State/province [35] 0 0
Sao Paulo
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Barrie
Country [38] 0 0
Canada
State/province [38] 0 0
Edmonton
Country [39] 0 0
Canada
State/province [39] 0 0
Fredericton
Country [40] 0 0
Canada
State/province [40] 0 0
Saskatoon
Country [41] 0 0
Canada
State/province [41] 0 0
Toronto
Country [42] 0 0
Chile
State/province [42] 0 0
Chi
Country [43] 0 0
Chile
State/province [43] 0 0
Region Metropolitana De Santiago
Country [44] 0 0
Chile
State/province [44] 0 0
Antofagasta
Country [45] 0 0
Chile
State/province [45] 0 0
Santiago
Country [46] 0 0
Chile
State/province [46] 0 0
Vina del Mar
Country [47] 0 0
Czechia
State/province [47] 0 0
Hradec Kralove
Country [48] 0 0
Czechia
State/province [48] 0 0
Ostrava
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Czechia
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Prague 10
Country [50] 0 0
France
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Besancon Cedex
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Bobigny
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Boulogne Billancourt
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Clermont-Ferrand
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Creteil
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Dijon
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Grenoble
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Le Mans
Country [59] 0 0
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Lille Cedex
Country [60] 0 0
France
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Lyon cedex 08
Country [61] 0 0
France
State/province [61] 0 0
Nantes
Country [62] 0 0
France
State/province [62] 0 0
Paris
Country [63] 0 0
France
State/province [63] 0 0
Pierre Benite Cedex
Country [64] 0 0
France
State/province [64] 0 0
Poitiers Cedex
Country [65] 0 0
France
State/province [65] 0 0
Rouen
Country [66] 0 0
France
State/province [66] 0 0
Saint-Etienne
Country [67] 0 0
France
State/province [67] 0 0
Strasbourg
Country [68] 0 0
France
State/province [68] 0 0
Villejuif Cedex
Country [69] 0 0
Georgia
State/province [69] 0 0
Batumi
Country [70] 0 0
Georgia
State/province [70] 0 0
Tbilisi
Country [71] 0 0
Germany
State/province [71] 0 0
Augsburg
Country [72] 0 0
Germany
State/province [72] 0 0
Berlin
Country [73] 0 0
Germany
State/province [73] 0 0
Bochum
Country [74] 0 0
Germany
State/province [74] 0 0
Buxtehude
Country [75] 0 0
Germany
State/province [75] 0 0
Dresden
Country [76] 0 0
Germany
State/province [76] 0 0
Erfurt
Country [77] 0 0
Germany
State/province [77] 0 0
Frankfurt
Country [78] 0 0
Germany
State/province [78] 0 0
Giessen
Country [79] 0 0
Germany
State/province [79] 0 0
Göttingen
Country [80] 0 0
Germany
State/province [80] 0 0
Kiel
Country [81] 0 0
Germany
State/province [81] 0 0
Leipzig
Country [82] 0 0
Germany
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Luebeck
Country [83] 0 0
Germany
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Mannheim
Country [84] 0 0
Germany
State/province [84] 0 0
Muenster
Country [85] 0 0
Germany
State/province [85] 0 0
Quedlinburg
Country [86] 0 0
Germany
State/province [86] 0 0
Regensburg
Country [87] 0 0
Germany
State/province [87] 0 0
Schwerin
Country [88] 0 0
Hungary
State/province [88] 0 0
Debrecen
Country [89] 0 0
Hungary
State/province [89] 0 0
Nyíregyhaza
Country [90] 0 0
Hungary
State/province [90] 0 0
Pecs
Country [91] 0 0
Hungary
State/province [91] 0 0
Szeged
Country [92] 0 0
Ireland
State/province [92] 0 0
Cork
Country [93] 0 0
Ireland
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Dublin 4
Country [94] 0 0
Ireland
State/province [94] 0 0
Dublin
Country [95] 0 0
Ireland
State/province [95] 0 0
Galway
Country [96] 0 0
Italy
State/province [96] 0 0
Bari
Country [97] 0 0
Italy
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Brescia
Country [98] 0 0
Italy
State/province [98] 0 0
Candiolo
Country [99] 0 0
Italy
State/province [99] 0 0
Cuneo
Country [100] 0 0
Italy
State/province [100] 0 0
Genova
Country [101] 0 0
Italy
State/province [101] 0 0
Monza
Country [102] 0 0
Italy
State/province [102] 0 0
Napoli
Country [103] 0 0
Italy
State/province [103] 0 0
Novara
Country [104] 0 0
Italy
State/province [104] 0 0
Padova
Country [105] 0 0
Italy
State/province [105] 0 0
Pisa
Country [106] 0 0
Italy
State/province [106] 0 0
Rome
Country [107] 0 0
Italy
State/province [107] 0 0
San Giovanni Rotondo
Country [108] 0 0
Italy
State/province [108] 0 0
Terni
Country [109] 0 0
Italy
State/province [109] 0 0
Trento
Country [110] 0 0
Italy
State/province [110] 0 0
Turin
Country [111] 0 0
Italy
State/province [111] 0 0
Udine
Country [112] 0 0
Mexico
State/province [112] 0 0
Chihuahua
Country [113] 0 0
Mexico
State/province [113] 0 0
Culiacan
Country [114] 0 0
Mexico
State/province [114] 0 0
Guadalajara
Country [115] 0 0
Mexico
State/province [115] 0 0
Leon
Country [116] 0 0
Mexico
State/province [116] 0 0
Merida
Country [117] 0 0
Mexico
State/province [117] 0 0
Monterrey
Country [118] 0 0
Mexico
State/province [118] 0 0
Tuxtla Gutierrez
Country [119] 0 0
Mexico
State/province [119] 0 0
Veracruz
Country [120] 0 0
Mexico
State/province [120] 0 0
Zapopan
Country [121] 0 0
Netherlands
State/province [121] 0 0
Amsterdam
Country [122] 0 0
Netherlands
State/province [122] 0 0
Groningen
Country [123] 0 0
Peru
State/province [123] 0 0
Arequipa
Country [124] 0 0
Peru
State/province [124] 0 0
Bellavista
Country [125] 0 0
Peru
State/province [125] 0 0
Concepcion
Country [126] 0 0
Peru
State/province [126] 0 0
Lima
Country [127] 0 0
Peru
State/province [127] 0 0
Trujillo
Country [128] 0 0
Poland
State/province [128] 0 0
Gdansk
Country [129] 0 0
Poland
State/province [129] 0 0
Krakow
Country [130] 0 0
Poland
State/province [130] 0 0
Poznan
Country [131] 0 0
Poland
State/province [131] 0 0
Siedlce
Country [132] 0 0
Poland
State/province [132] 0 0
Slupsk
Country [133] 0 0
Poland
State/province [133] 0 0
Warszawa
Country [134] 0 0
Romania
State/province [134] 0 0
Bucharest
Country [135] 0 0
Romania
State/province [135] 0 0
Cluj Napoca
Country [136] 0 0
Romania
State/province [136] 0 0
Cluj-Napoca
Country [137] 0 0
Romania
State/province [137] 0 0
Cluj
Country [138] 0 0
Romania
State/province [138] 0 0
Craiova
Country [139] 0 0
Romania
State/province [139] 0 0
Iasi
Country [140] 0 0
Romania
State/province [140] 0 0
Otopeni
Country [141] 0 0
Romania
State/province [141] 0 0
Timisoara
Country [142] 0 0
South Africa
State/province [142] 0 0
Cape Town
Country [143] 0 0
South Africa
State/province [143] 0 0
Johannesburg
Country [144] 0 0
South Africa
State/province [144] 0 0
Kraaifontein
Country [145] 0 0
Spain
State/province [145] 0 0
A Coruna
Country [146] 0 0
Spain
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Badalona
Country [147] 0 0
Spain
State/province [147] 0 0
Barcelona
Country [148] 0 0
Spain
State/province [148] 0 0
Cordoba
Country [149] 0 0
Spain
State/province [149] 0 0
Girona
Country [150] 0 0
Spain
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Granada
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Spain
State/province [151] 0 0
Lugo
Country [152] 0 0
Spain
State/province [152] 0 0
Madrid
Country [153] 0 0
Spain
State/province [153] 0 0
Malaga
Country [154] 0 0
Spain
State/province [154] 0 0
Múrcia
Country [155] 0 0
Spain
State/province [155] 0 0
Oviedo
Country [156] 0 0
Spain
State/province [156] 0 0
San Sebastian
Country [157] 0 0
Spain
State/province [157] 0 0
Sevilla
Country [158] 0 0
Spain
State/province [158] 0 0
Valencia
Country [159] 0 0
Turkey
State/province [159] 0 0
Adana
Country [160] 0 0
Turkey
State/province [160] 0 0
Ankara
Country [161] 0 0
Turkey
State/province [161] 0 0
Diyarbakir
Country [162] 0 0
Turkey
State/province [162] 0 0
Edirne
Country [163] 0 0
Turkey
State/province [163] 0 0
Gaziantep
Country [164] 0 0
Turkey
State/province [164] 0 0
Istanbul
Country [165] 0 0
Turkey
State/province [165] 0 0
Kocaeli
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Devon
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Guildford
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Hull
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Leeds
Country [170] 0 0
United Kingdom
State/province [170] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is researching an experimental drug called REGN3767, also known as fianlimab
(R3767), when combined with another medication called REGN2810, also known as cemiplimab
(each individually called a "study drug" or called "study drugs" when combined). The study is
focused on patients with a type of skin cancer known as melanoma.

The aims of the study are to see how effective the combination of fianlimab and cemiplimab
are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab,
approved for the treatment of melanoma skin cancer in adults, and to observe any
similarities, or differences, in how the study drugs work in adolescent participants compared
with adult participants.

The study is looking at several other research questions, including:

- What side effects may happen from receiving the study drugs

- How much study drug is in the blood at different times

- Whether the body makes antibodies against the study drugs (which could make the drugs
less effective or could lead to side effects). Antibodies are proteins that are
naturally found in the blood stream that fight infections.

- How administering the study drugs might improve quality of life
Trial website
https://clinicaltrials.gov/ct2/show/NCT05352672
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
clinicaltrials@regeneron.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05352672