Back to resultsNeoadjuvant 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 (CheckMate 7UA)
Primary Purpose
Melanoma
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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
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
Sites / Locations
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Neoadjuvant treatment + Adjuvant treatment
Adjuvant treatment
Neo treat with patho response-driven Adju treat or observation
Arm Description
Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
Outcomes
Primary Outcome Measures
Event-free survival (EFS)
Secondary Outcome Measures
Recurrence-free survival (RFS) Time from Surgery
RFS Time from Adjuvant Therapy
Pathologic response rate (pRR) by immune-related pathologic response (irPR)
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
RFS by MPR
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of deaths
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04495010
Brief 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
Acronym
CheckMate 7UA
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Business objectives have changed
Study Start Date
March 31, 2021 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
October 23, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neoadjuvant treatment + Adjuvant treatment
Arm Type
Experimental
Arm Title
Adjuvant treatment
Arm Type
Experimental
Arm Title
Neo treat with patho response-driven Adju treat or observation
Arm Type
Experimental
Arm Description
Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Event-free survival (EFS)
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Recurrence-free survival (RFS) Time from Surgery
Time Frame
Up to 5 years
Title
RFS Time from Adjuvant Therapy
Time Frame
Up to 5 years
Title
Pathologic response rate (pRR) by immune-related pathologic response (irPR)
Time Frame
Up to 5 years
Title
Concordance major pathologic response (MPR) by local and central pathology Review
Description
MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR
Time Frame
Up to 5 years
Title
RFS by MPR
Time Frame
Up to 5 years
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 5 years
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
Up to 5 years
Title
Incidence of deaths
Time Frame
Up to 5 years
Title
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame
Up to 5 years
Title
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame
Up to 5 years
Title
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame
Up to 5 years
Title
Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Local Institution
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Local Institution
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Local Institution
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Local Institution
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Local Institution
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Local Institution
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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United States
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Local Institution
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
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United States
Facility Name
Local Institution
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
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United States
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Local Institution
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
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United States
Facility Name
Local Institution
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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United States
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Local Institution
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
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United States
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Local Institution
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New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
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United States
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Local Institution
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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United States
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Local Institution
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
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United States
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Local Institution
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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United States
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Local Institution
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Local Institution
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Local Institution
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Local Institution
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Local Institution
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
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Australia
Facility Name
Local Institution
City
Doubleview
State/Province
Western Australia
ZIP/Postal Code
6018
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
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Australia
Facility Name
Local Institution
City
Graz
ZIP/Postal Code
803 6
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Austria
Facility Name
Local Institution
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Local Institution
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution
City
St. Poelten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Local Institution
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60135237
Country
Brazil
Facility Name
Local Institution
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80530-010
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Local Institution
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Local Institution
City
Sao Jose do Rio Preto
State/Province
SAO Paulo
ZIP/Postal Code
15092-415
Country
Brazil
Facility Name
Local Institution
City
Rio De Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
05308-020
Country
Brazil
Facility Name
Local Institution
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Local Institution
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Local Institution
City
Odense C
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Local Institution
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Local Institution
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Nice
ZIP/Postal Code
6200
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution
City
Pierre-Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Local Institution
City
Sr Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Local Institution
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Local Institution
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Local Institution
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Local Institution
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Local Institution
City
Geleen
ZIP/Postal Code
6162bg
Country
Netherlands
Facility Name
Local Institution
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Local Institution
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Local Institution
City
Krasnodar
ZIP/Postal Code
350000
Country
Russian Federation
Facility Name
Local Institution
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Haddon Heights
ZIP/Postal Code
8035
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Local Institution
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Local Institution
City
Vaxjo
ZIP/Postal Code
352 34
Country
Sweden
Facility Name
Local Institution
City
Zuerich
ZIP/Postal Code
CH - 8091
Country
Switzerland
Facility Name
Local Institution
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Local Institution
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Local Institution
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Local Institution
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Local Institution
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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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