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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
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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
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Secondary ID [1]
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2022-501576-25-00
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Secondary ID [2]
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R3767-ONC-2055
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Relapse free survival (RSF)
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Assessment method [1]
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Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.
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Timepoint [1]
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Up to 5 Years
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Secondary outcome [1]
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Distant metastasis-free survival (DMFS)
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Assessment method [1]
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Time between the date of randomization and the date of the first distant metastasis.
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Timepoint [1]
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Up to 5 Years
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Secondary outcome [2]
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Overall survival (OS)
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Assessment method [2]
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Time from randomization to the date of death.
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Timepoint [2]
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Up to 5 Years
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Secondary outcome [3]
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Occurrence of treatment-emergent adverse events (TEAEs)
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Assessment method [3]
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A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
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Timepoint [3]
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Up to 5 Years
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Secondary outcome [4]
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Occurrence of immune-mediated EAEs (im-EAEs)
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Assessment method [4]
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imAEs are a unique set of toxicities thought to be caused by unrestrained cellular immune responses.
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Timepoint [4]
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Up to 5 Years
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Secondary outcome [5]
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Occurrence of serious adverse events (SAEs)
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Assessment method [5]
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An SAE is any untoward medical occurrence that at any dose:
* Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger).
* Is life-threatening
* Requires in-patient hospitalization or prolongation of existing hospitalization.
* Results in persistent or significant disability/incapacity
* Is a congenital anomaly/birth defect.
* Is an important medical event
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Timepoint [5]
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Up to 5 Years
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Secondary outcome [6]
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Occurrence of adverse events of special interest (AESIs)
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Assessment method [6]
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An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it
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Timepoint [6]
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0
Up to 5 Years
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Secondary outcome [7]
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Occurrence of TEAEs resulting in death
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Assessment method [7]
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A TEAE resulting in death is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
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Timepoint [7]
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0
Up to 5 Years
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Secondary outcome [8]
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Occurrence of dose-limiting toxicity (DLT)
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Assessment method [8]
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A DLT is defined as a study-drug related TEAE, including imAEs, that could preclude enrolling additional adolescent patients at the selected dose. Dose-limiting toxicity will be evaluated in adolescents only.
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Timepoint [8]
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0
Up to 5 Years
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Secondary outcome [9]
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Occurrence of interruption or discontinuation of study drug(s) due to TEAE
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Assessment method [9]
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0
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
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Timepoint [9]
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Up to 5 Years
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Secondary outcome [10]
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Occurrence of laboratory abnormalities
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Assessment method [10]
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As assessed by the NCI-CTCAE grading system (= Grade 3 or higher)
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Timepoint [10]
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Up to 5 Years
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Secondary outcome [11]
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Concentrations of fianlimab in serum over time
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Assessment method [11]
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The concentrations of fianlimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.
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Timepoint [11]
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Up to 5 Years
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Secondary outcome [12]
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Concentrations of cemiplimab in serum over time
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Assessment method [12]
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The concentrations of cemiplimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.
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Timepoint [12]
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Up to 5 Years
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Secondary outcome [13]
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Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies
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Assessment method [13]
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Immunogenicity will be characterized per drug molecule by ADA and NAb status.
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Timepoint [13]
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Up to 5 Years
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Secondary outcome [14]
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Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies
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Assessment method [14]
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Immunogenicity will be characterized per drug molecule by ADA and NAb status.
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Timepoint [14]
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Up to 5 Years
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Secondary outcome [15]
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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)
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Assessment method [15]
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The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome.
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Timepoint [15]
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Up to 5 Year
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Secondary outcome [16]
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PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L)
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Assessment method [16]
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The EQ-5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
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Timepoint [16]
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Up to 5 Years
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Secondary outcome [17]
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PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma
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Assessment method [17]
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The FACT-M is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-M is scored on a 5 point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL).
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Timepoint [17]
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Up to 5 Years
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Secondary outcome [18]
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PRO for adults as determined by the Patient Global Impressions Scale (PGIS)
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Assessment method [18]
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The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
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Timepoint [18]
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Up to 5 Years
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Secondary outcome [19]
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PRO for adults as determined by the Patient Global Impressions of Change Scale (PGIC)
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Assessment method [19]
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The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".
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Timepoint [19]
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Up to 5 Years
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Secondary outcome [20]
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Time to global health status/quality of life deterioration per EORTC QLQ-C30
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Assessment method [20]
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0
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Timepoint [20]
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Up to 5 years
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Secondary outcome [21]
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Time to physical functioning deterioration per EORTC QLQ-C30
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Assessment method [21]
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0
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Timepoint [21]
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Up to 5 Years
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Secondary outcome [22]
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Time to role functioning deterioration per EORTC QLQ-C30
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Assessment method [22]
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0
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Timepoint [22]
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Up to 5 Years
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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
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/02/2030
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Actual
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Sample size
Target
1530
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Lismore Base Hospital - Lismore
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Recruitment hospital [2]
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Liverpool Hospital (Cancer Therapy Pharmacy) - Liverpool
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Recruitment hospital [3]
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Calvary North Adelaid Hospital (HPS Pharmacies) - Adelaide
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Recruitment hospital [4]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [5]
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Box Hill Hospital - Box Hill
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Recruitment hospital [6]
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Andrew Love Cancer Centre, University Hospital Geelong - Geelong
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Recruitment hospital [7]
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Alfred Health - Melbourne
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Recruitment hospital [8]
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One Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2480 - Lismore
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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5006 - Adelaide
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Recruitment postcode(s) [4]
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5042 - Bedford Park
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3220 - Geelong
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Recruitment postcode(s) [7]
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3004 - Melbourne
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Colorado
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United States of America
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Florida
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Country [4]
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United States of America
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Illinois
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Country [5]
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United States of America
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Massachusetts
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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Country [15]
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Argentina
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Buenos Aires
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Country [16]
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Argentina
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State/province [16]
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Rio Negro
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Argentina
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Santa Fe
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Argentina
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Tacuman Province
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Belgium
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State/province [19]
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East Flanders
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Belgium
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Region De Bruxelles
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Belgium
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West-Vlaaderen
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Brazil
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Minas Geraise
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Brazil
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Parana
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Brazil
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Rio De Janeiro
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Sao Paulo Estado
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Brazil
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Sao Paulo
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Canada
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New Brunswick
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Canada
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Ontario
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Chile
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Metropolitana De Santiago
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Chile
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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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South Moravian
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France
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Bourgogne-Franche-Comte
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France
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Bourgogne-Franche-Comté
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France
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Bourgogne
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Grenoble
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Haute-Garonne
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Nord Deparment
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Normandy
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France
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Nouvelle-Aquitaine
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Occitanie Region
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Paris
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Puy-de-Dôme
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France
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Sarthe
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France
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Seine Saint Denis
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France
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Somme
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France
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Villejuif Cedex
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France
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Nice
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France
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Rouen
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Georgia
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Adjara
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Georgia
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South Caucasus
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Germany
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Baden-Wurttemberg
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Germany
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Bavaria
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Germany
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Hessen
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Germany
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Lower Saxony
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Germany
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Mecklenburg Vorpommern
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Germany
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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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Germany
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Saxony
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Germany
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Schleswig-Holstein
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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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Bremen
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Germany
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Erfurt
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Germany
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Germany
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Athens
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Italy
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Milano
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Italy
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Italy
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Italy
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Italy
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Italy
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Novara
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Italy
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Italy
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Floresti
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Moldava
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Romania
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Timis
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Bucharest
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Madrid
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Valencia
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Turkey
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Edime
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Gaziantep
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Istanbul
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United Kingdom
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Devon
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London
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United Kingdom
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Lothian
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United Kingdom
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Somerset
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Regeneron Pharmaceuticals
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Summary
Brief summary
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. 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 drug (which could make the drug 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.
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Trial website
https://clinicaltrials.gov/study/NCT05608291
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Public notes
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Contacts
Principal investigator
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Clinical Trial Management
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Regeneron Pharmaceuticals
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Clinical Trials Administrator
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844-734-6643
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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
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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.
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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
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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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