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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
2020-000070-16
Secondary ID [2] 0 0
CA209-7UA
Universal Trial Number (UTN)
Trial acronym
CheckMate 7UA
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
Other interventions - Nivolumab
Other interventions - 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


Other interventions: Nivolumab
Specified dose on specified days

Other interventions: Ipilimumab
Specified dose on specified days

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free survival (EFS)
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Recurrence-free survival (RFS) Time from Surgery
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
RFS Time from Adjuvant Therapy
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Pathologic response rate (pRR) by immune-related pathologic response (irPR)
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Concordance major pathologic response (MPR) by local and central pathology Review - MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
RFS by MPR
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Incidence of Adverse Events (AEs)
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Incidence of deaths
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)
Timepoint [12] 0 0
Up to 5 years

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
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - North Sydney
Recruitment hospital [2] 0 0
Local Institution - Westmead
Recruitment hospital [3] 0 0
Local Institution - Greenslopes
Recruitment hospital [4] 0 0
Local Institution - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - Adelaide
Recruitment hospital [6] 0 0
Local Institution - Hobart
Recruitment hospital [7] 0 0
Local Institution - Ballarat
Recruitment hospital [8] 0 0
Local Institution - Melbourne
Recruitment hospital [9] 0 0
Local Institution - Doubleview
Recruitment hospital [10] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
4120 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3350 - Ballarat
Recruitment postcode(s) [8] 0 0
3000 - Melbourne
Recruitment postcode(s) [9] 0 0
3004 - Melbourne
Recruitment postcode(s) [10] 0 0
6018 - Doubleview
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Austria
State/province [18] 0 0
Graz
Country [19] 0 0
Austria
State/province [19] 0 0
Innsbruck
Country [20] 0 0
Austria
State/province [20] 0 0
Salzburg
Country [21] 0 0
Austria
State/province [21] 0 0
St. Poelten
Country [22] 0 0
Austria
State/province [22] 0 0
Wien
Country [23] 0 0
Belgium
State/province [23] 0 0
Brussels
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Belgium
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Gent
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Belgium
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Wilrijk
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Brazil
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Ceara
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Distrito Federal
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Brazil
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Parana
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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
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Brazil
State/province [32] 0 0
Rio De Janeiro
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Brazil
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Sao Paulo
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Denmark
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Aarhus
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Denmark
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Herlev
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Denmark
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Odense C
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France
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Bordeaux
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Lille
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Nantes
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Nice
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France
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Paris
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France
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Pierre-Benite
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France
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Rennes
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France
State/province [46] 0 0
Sr Priest En Jarez
Country [47] 0 0
France
State/province [47] 0 0
Toulouse
Country [48] 0 0
France
State/province [48] 0 0
Villejuif
Country [49] 0 0
Germany
State/province [49] 0 0
Berlin
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Hannover
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Germany
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Heidelberg
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Kiel
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Luebeck
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Germany
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Mainz
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Regensburg
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Tuebingen
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Germany
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Wuerzburg
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Italy
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Bergamo
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Italy
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Meldola
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Italy
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Napoli
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Novara
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Padova
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Pavia
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Amsterdam
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Breda
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Geleen
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Leiden
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Rotterdam
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Utrecht
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Poland
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Krakow
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Warszawa
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Wroclaw
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Russian Federation
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Krasnodar
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Ryazan
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Russian Federation
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Saint Petersburg
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Saint-Petersburg
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Spain
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Barcelona
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Haddon Heights
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Malaga
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Oviedo
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Santiago de Compostela
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Sevilla
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Sweden
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Vaxjo
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Switzerland
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Zuerich
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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Guildford
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United Kingdom
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Leeds
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United Kingdom
State/province [92] 0 0
London
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United Kingdom
State/province [93] 0 0
Manchester
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United Kingdom
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Northwood
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Oxford
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04495010
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04495010