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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04495010
Registration number
NCT04495010
Ethics application status
Date submitted
30/07/2020
Date registered
31/07/2020
Date last updated
19/03/2021
Titles & IDs
Public title
Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants
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Scientific title
A Phase 2, Randomized Study of Neoadjuvant Nivolumab Plus Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab Plus Ipilimumab Followed by Either Adjuvant Nivolumab or Postsurgical Observation Depending on Pathologic Response Compared With Adjuvant Nivolumab in Treatment-Naive Patients With Resectable Clinically Detectable Stage III Melanoma
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Secondary ID [1]
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2020-000070-16
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Secondary ID [2]
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CA209-7UA
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 7UA
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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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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - Ipilimumab
Experimental: Neoadjuvant treatment + Adjuvant treatment -
Experimental: Adjuvant treatment -
Experimental: Neo treat with patho response-driven Adju treat or observation - Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
Treatment: Other: Nivolumab
Specified dose on specified days
Treatment: Other: Ipilimumab
Specified dose on specified days
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Intervention code [1]
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Treatment: Other
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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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Event-free survival (EFS)
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Assessment method [1]
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Timepoint [1]
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Up to 4 years
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Secondary outcome [1]
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Recurrence-free survival (RFS) Time from Surgery
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Assessment method [1]
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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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RFS Time from Adjuvant Therapy
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Assessment method [2]
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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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Pathologic response rate (pRR) by immune-related pathologic response (irPR)
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Assessment method [3]
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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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Concordance major pathologic response (MPR) by local and central pathology Review
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Assessment method [4]
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MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR
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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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RFS by MPR
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Assessment method [5]
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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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Incidence of Adverse Events (AEs)
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Timepoint [6]
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Secondary outcome [7]
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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Incidence of deaths
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Assessment method [8]
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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Incidence of clinically significant changes in clinical laboratory results: Hematology tests
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Assessment method [9]
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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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Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
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Assessment method [10]
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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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Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
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Assessment method [11]
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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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Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)
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Assessment method [12]
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Timepoint [12]
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* Males and females, = 12 years of age [Except: where local regulations and/or institutional policies do not allow for participants < 18 years of age (adolescent population) to participate. For those sites, the eligible participant population is 18 years of age or local age of majority, inclusive]
* Diagnosed with cytologically or histologically confirmed Stage IIIB, IIIC, or IIID cutaneous melanoma as per American Joint Committee on Cancer (AJCC) staging system, with = 1 clinically detectable lymph node metastases (N1b, N2b, N3b), which are measurable according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
* Adult participants and adolescents 16 to 18 years old must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1. Adolescents < 16 years old must have Lanksky Play-Performance Status scale performance of = 60
* Must be treatment-naïve (ie, no prior systemic anticancer therapy as adjuvant therapy for melanoma or unresectable/metastatic melanoma)
* Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
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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
* Women who are breastfeeding
* Patients with serious or uncontrolled medical disorders
* Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
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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Masking / blinding
Open (masking not used)
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Intervention assignment
Parallel
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Phase
Phase 2
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Recruitment
Recruitment status
Withdrawn
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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
31/03/2021
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Actual
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
23/10/2027
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Actual
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Sample size
Target
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Final
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Recruitment in Australia
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NSW,QLD,SA,TAS,VIC,WA
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2060 - North Sydney
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2145 - Westmead
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4120 - Greenslopes
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4120 - Woolloongabba
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5000 - Adelaide
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7000 - Hobart
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3350 - Ballarat
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3000 - Melbourne
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3004 - Melbourne
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6018 - Doubleview
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6009 - Nedlands
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.
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Trial website
https://clinicaltrials.gov/study/NCT04495010
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT04495010
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