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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05352672
Ethics application status
Date submitted
6/04/2022
Date registered
29/04/2022

Titles & IDs
Public title
Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Scientific title
A 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 - Protocol Amendment 1: 40 participants randomized 2:1:1 (Futility Analysis) Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)

Experimental: A1: fianlimab+cemiplimab dose 2 - Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)

Experimental: B: pembrolizumab+placebo - Protocol Amendment 1: 40 participants randomized 2:1:1 (Futility Analysis) Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)

Experimental: C: cemiplimab+placebo - Protocol Amendment 1: 40 participants randomized 2:1:1 (Futility Analysis) Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population)


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
Progression-free survival (PFS)
Timepoint [1] 0 0
Approximately 27 months
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to 96 months
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Up to 27 months
Secondary outcome [3] 0 0
Disease control rate (DCR)
Timepoint [3] 0 0
Up to 27 months
Secondary outcome [4] 0 0
Duration of response (DoR)
Timepoint [4] 0 0
Up to 27 months
Secondary outcome [5] 0 0
PFS
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
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 irAEs = 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.
2. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.
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 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. 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 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
1590
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
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United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
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Ohio
Country [5] 0 0
United States of America
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Tennessee
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Argentina
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Caba
Country [8] 0 0
Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Austria
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Tyrol
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Austria
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Graz
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Austria
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St. Poelten
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Kortrijk
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Belgium
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Namur
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Belgium
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Sint Niklaas
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Barretos
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Belo Horizonte
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Curitiba
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Ijui
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Itajai
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Joinville
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Lages
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Lajeado
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Passo Fundo
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Porto Alegre
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Brazil
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Porto Velho
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Santo Cristo
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Sao Jose do Rio Preto
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Sao paulo
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Sao Paulo
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Canada
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Ontario
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Barrie
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Edmonton
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Fredericton
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Canada
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Saskatoon
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Toronto
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Chi
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Santiago
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Chile
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Vina del Mar
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Czechia
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Hradec Kralove
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Czechia
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Prague 10
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Pierre Benite Cedex
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Poitiers Cedex
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Rouen
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Saint-Etienne
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Strasbourg
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France
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Villejuif Cedex
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Georgia
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Batumi
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Georgia
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Tbilisi
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Augsburg
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Buxtehude
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Germany
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Dessau
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Germany
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Dresden
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Erfurt
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Germany
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Frankfurt
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Germany
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Giessen
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Germany
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Göttingen
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Germany
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Kiel
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Germany
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Leipzig
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Luebeck
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Muenster
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Germany
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Munchen
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Germany
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Nuremberg
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Germany
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Quedlinburg
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Germany
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Regensburg
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Germany
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Schwerin
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Germany
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Tuebingen
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Hungary
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Debrecen
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Hungary
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Nyíregyhaza
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Hungary
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Pecs
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Hungary
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Szeged
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Ireland
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Cork
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Ireland
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Dublin 4
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Brescia
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Italy
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Candiolo
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Italy
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Cuneo
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Italy
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Genova
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Milano
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Italy
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Monza
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Napoli
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Italy
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Novara
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Padova
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Pisa
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Roma
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Italy
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Rome
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Italy
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Rozzano
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Italy
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San Giovanni Rotondo
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Italy
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Terni
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Italy
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Trento
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Italy
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Turin
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Chihuahua
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Mexico
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Mexico
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Guadalajara
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Mexico
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Leon
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Mexico
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Merida
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Mexico
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Monterrey
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Tuxtla Gutierrez
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Mexico
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Veracruz
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Mexico
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Zapopan
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Amsterdam
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Groningen
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Peru
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Arequipa
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Peru
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Bellavista
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Peru
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Peru
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Lima
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Peru
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San Borja
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Peru
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Trujillo
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Poznan
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Poland
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Siedlce
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Poland
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Slupsk
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Poland
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Warszawa
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Romania
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Cluj-Napoca
Country [146] 0 0
Romania
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Cluj
Country [147] 0 0
Romania
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Craiova
Country [148] 0 0
Romania
State/province [148] 0 0
Iasi
Country [149] 0 0
Romania
State/province [149] 0 0
Otopeni
Country [150] 0 0
Romania
State/province [150] 0 0
Timisoara
Country [151] 0 0
South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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Kraaifontein
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Spain
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A Coruna
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Girona
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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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Malaga
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Múrcia
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Oviedo
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Spain
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San Sebastian
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Spain
State/province [166] 0 0
Sevilla
Country [167] 0 0
Spain
State/province [167] 0 0
Valencia
Country [168] 0 0
Turkey
State/province [168] 0 0
Adana
Country [169] 0 0
Turkey
State/province [169] 0 0
Ankara
Country [170] 0 0
Turkey
State/province [170] 0 0
Diyarbakir
Country [171] 0 0
Turkey
State/province [171] 0 0
Edirne
Country [172] 0 0
Turkey
State/province [172] 0 0
Gaziantep
Country [173] 0 0
Turkey
State/province [173] 0 0
Istanbul
Country [174] 0 0
Turkey
State/province [174] 0 0
Izmir
Country [175] 0 0
Turkey
State/province [175] 0 0
Kocaeli
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Devon
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Guildford
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Hull
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Leeds
Country [180] 0 0
United Kingdom
State/province [180] 0 0
London

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 the study 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/NCT05352672