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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/NCT04410445
Registration number
NCT04410445
Ethics application status
Date submitted
27/05/2020
Date registered
1/06/2020
Date last updated
21/04/2023
Titles & IDs
Public title
Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
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Scientific title
A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)
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Secondary ID [1]
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20-214-29/CA045-022
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Universal Trial Number (UTN)
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Trial acronym
PIVOT-12
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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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Melanoma Stage III
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Melanoma Stage IV
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Melanoma (Skin)
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Condition category
Condition code
Cancer
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0
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0
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Malignant melanoma
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Bempegaldesleukin
Other interventions - Nivolumab
Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab - Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
Active Comparator: Nivolumab - Arm B: Participants will receive nivolumab IV alone every 4 weeks.
Other interventions: Bempegaldesleukin
Specified dose on specified days
Other interventions: Nivolumab
Specified dose on specified days
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Intervention code [1]
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Other interventions
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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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Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
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Assessment method [1]
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Recurrence-free Survival (RFS) of bempegaldesleukin plus nivolumab versus nivolumab alone is determined based on the disease recurrence date provided by Blinded Independent Central Review (BICR) and is defined as the time between date of randomization and date of first recurrence (local, regional, or distant metastasis by BICR), new primary melanoma (by BICR), or all-cause death, whichever occurs first.
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Timepoint [1]
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Up to 21 months
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Secondary outcome [1]
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Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone
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Assessment method [1]
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Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. Patients who do not have a date of death will be censored on the last date for which a patient was known to be alive.
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Timepoint [1]
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Up to 21 months
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Secondary outcome [2]
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Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.
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Assessment method [2]
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Distant metastasis-free survival (DMFS) by Investigator is defined as the time between the date of randomization and the date of first distant metastasis by Investigator or date of death due to any cause, in patients who have Stage III melanoma at study entry.
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Timepoint [2]
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Up to 21 months
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Secondary outcome [3]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [3]
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To evaluate safety and tolerability of (NKTR-214) 0.006 mg/kg in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients <40 kg) and nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients < 40 kg). Treatment-emergent adverse event (TEAE) is defined as an AE that was not present prior to treatment with study drug but appeared following treatment or was present at treatment start date but worsened during treatment-emergent period. The treatment-emergent period is defined as the period from the date of the first dose of study drug up to 30 days after the date of the last dose of study drug or the day prior to the initiation of subsequent anticancer treatment, whichever occurs first.
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Timepoint [3]
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Approximately up to 21 months
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Secondary outcome [4]
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Changes at 6 Months of Treatment From Baseline in Scores for the Global Health/Quality of Life (GH/QoL) and Physical Functioning Subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire
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Assessment method [4]
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The EORTC QLQ-C30 comprises 30 items (i.e. single questions). 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the global health status/quality of life scale indicates a better level of functioning, and positive changes from baseline indicate improvement. A change of 5 - 10 points is considered a small change, and a change of 10 - 20 points is considered a moderate change. Due to the study termination, results for the mean change from baseline for GH/QoL and the physical functioning subscale were analyzed at approximately 6 months of treatment.
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Timepoint [4]
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From baseline, up to approximately 6 months
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Secondary outcome [5]
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Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS)
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Assessment method [5]
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The predictive strength of Programmed Death-Ligand 1 (PD-L1) expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level.
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Timepoint [5]
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Up to 21 months
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Secondary outcome [6]
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Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
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Assessment method [6]
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Recurrence-free Survival by Investigator is defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis by Investigator), new primary melanoma (by Investigator), or all-cause death, whichever occurs first.
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Timepoint [6]
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Up to 21 months
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Secondary outcome [7]
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Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab
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Assessment method [7]
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Time to disease progression after the next line of treatment is defined as time from randomization to progression per Investigator after the start of next line of therapy or death, whichever occurs first. Patients who were alive and without progression after the next line of therapy can be censored at last known alive date.
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Timepoint [7]
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Up to 21 months
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Secondary outcome [8]
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Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry.
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Assessment method [8]
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Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) is defined as the time between the date of randomization and the date of first distant metastasis by BICR or date of death due to any cause, whichever occurs first, in patients who have Stage III melanoma at study entry.
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Timepoint [8]
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Up to 21 months
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Eligibility
Key inclusion criteria
- Male or female patients, age 12 years or older at the time of signing the informed
consent form (age 18 years or older where local regulations, countries, and/or
institutional policies do not allow for patients < 18 years of age (adolescents) to
participate). In regions where adolescents are not allowed to participate in the study
due to age restrictions, enrolled patients must be = 18 years of age.
- Histologically confirmed Stage IIIA (LN metastasis > 1 mm), IIIB/C/D, or IV
(M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been
completely surgically resected within 12 weeks prior to randomization.
- Tumor tissue available from biopsy or resected disease must be provided to central
laboratory for PD-L1 status analysis. Must have PD-L1 expression classification for
stratification purposes.
- Disease-free status documented by a complete physical examination and imaging studies
within 28 days prior to randomization.
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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
- History of ocular/uveal melanoma or mucosal melanoma.
- Active, known or suspected autoimmune disease. Patients with Type I diabetes mellitus,
hypothyroidism only requiring hormone replacement, skin disorders not requiring
systemic treatment, or conditions not expected to recur in the absence of an external
trigger are permitted to enroll.
- Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily
prednisone equivalent) or other immunosuppressive medications within 14 days of
randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10
mg daily prednisone equivalent, are permitted in the absence of active autoimmune
disease.
- Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant
radiation therapy for central nervous system lesions.
- Prior therapy with interferon, talimogene laherparepvec (Imylgic®), interleukin-2
(IL-2) directed therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-cytotoxic T lymphocyte-associated protein 4 antibody (including ipilimumab or any
other antibody or drug specifically targeting T cell co-stimulation or checkpoint
pathways).
- Prior malignancy active within the previous 3 years except for locally potentially
curable cancers that have been apparently cured.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
Terminated
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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
27/07/2020
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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
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Actual
22/09/2022
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Sample size
Target
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Accrual to date
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Final
765
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Cairns Hospital - Cairns
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Recruitment hospital [3]
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Icon Cancer Care Wesley - Chermside
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Recruitment hospital [4]
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Gallipoli Medical Research Foundation - Greenslopes
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Recruitment hospital [5]
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Austin Health - Heidelberg
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Recruitment hospital [6]
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Alfred Hospital - Melbourne
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Recruitment hospital [7]
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Affinity Clinical Research - Nedlands
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Recruitment hospital [8]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [9]
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Melanoma Institute Australia - North Sydney
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Recruitment hospital [10]
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Gold Coast University Hospital - Southport
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Tasman Oncology Research - Southport
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Recruitment hospital [12]
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Blacktown Hospital - Westmead
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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5000 - Adelaide
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4870 - Cairns
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Recruitment postcode(s) [3]
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4032 - Chermside
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Recruitment postcode(s) [4]
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4120 - Greenslopes
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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3004 - Melbourne
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment postcode(s) [8]
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2000 - North Sydney
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Recruitment postcode(s) [9]
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4215 - Southport
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Recruitment postcode(s) [10]
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2145 - Westmead
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Recruitment postcode(s) [11]
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4102 - Woolloongabba
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Recruitment outside Australia
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California
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Colorado
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District of Columbia
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Florida
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Illinois
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Indiana
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Louisiana
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Israel
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Ramat Gan
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Italy
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Bari
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Italy
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Bergamo
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Italy
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Candiolo
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Italy
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Genova
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Italy
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Meldola
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Italy
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
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Padova
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Italy
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Siena
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Netherlands
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Amsterdam
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Netherlands
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Heerlen
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Netherlands
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Leeuwarden
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Netherlands
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Leiden
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Netherlands
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Nijmegen
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Netherlands
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Utrecht
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Netherlands
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Veldhoven
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Netherlands
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Zwolle
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Heidelberg
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New Zealand
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Tauranga
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New Zealand
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Wellington
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Lublin
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Poland
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Poznan
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Lisbon
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Portugal
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Porto
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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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Craiova
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Russian Federation
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Chelyabinsk
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Russian Federation
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Krasnodar
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Kursk
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Russian Federation
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Pushkin
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Russian Federation
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Ryazan'
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Russian Federation
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Saint Petersburg
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Russian Federation
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Yaroslavl
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Spain
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A Coruña
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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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Córdoba
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Spain
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El Palmar
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Spain
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Jaén
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Spain
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L'Hospitalet De Llobregat
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Sevilla
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Spain
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Valencia
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United Kingdom
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Cambridge
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United Kingdom
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Cottingham
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United Kingdom
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Leicester
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United Kingdom
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Nottingham
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United Kingdom
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Nektar Therapeutics
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Bristol-Myers Squibb
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Ethics approval
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Summary
Brief summary
The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab
versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous
melanoma who are at high risk for recurrence.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04410445
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Contacts
Principal investigator
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Study Director
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Nektar Therapeutics
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04410445
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