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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
CheckMate 7UA
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
2 other identifiers
interventional
N/A
15 countries
113
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2021
Longer than P75 for phase_2
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 31, 2020
CompletedStudy Start
First participant enrolled
March 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2027
ExpectedMarch 19, 2021
March 1, 2021
2.9 years
July 30, 2020
March 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Event-free survival (EFS)
Up to 4 years
Secondary Outcomes (12)
Recurrence-free survival (RFS) Time from Surgery
Up to 5 years
RFS Time from Adjuvant Therapy
Up to 5 years
Pathologic response rate (pRR) by immune-related pathologic response (irPR)
Up to 5 years
Concordance major pathologic response (MPR) by local and central pathology Review
Up to 5 years
RFS by MPR
Up to 5 years
- +7 more secondary outcomes
Study Arms (3)
Neoadjuvant treatment + Adjuvant treatment
EXPERIMENTALAdjuvant treatment
EXPERIMENTALNeo treat with patho response-driven Adju treat or observation
EXPERIMENTALNeoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
Interventions
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (118)
Local Institution
Gilbert, Arizona, 85234, United States
Local Institution
Tucson, Arizona, 85724, United States
Local Institution
San Francisco, California, 94158, United States
Local Institution
Aurora, Colorado, 80045, United States
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Tampa, Florida, 33612, United States
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Atlanta, Georgia, 30322, United States
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Atlanta, Georgia, 30342, United States
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Marietta, Georgia, 30060, United States
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Annapolis, Maryland, 21401, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02215, United States
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Minneapolis, Minnesota, 55407, United States
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Minneapolis, Minnesota, 55455, United States
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Hattiesburg, Mississippi, 39401, United States
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St Louis, Missouri, 63110, United States
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Morristown, New Jersey, 07960, United States
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New Brunswick, New Jersey, 08901, United States
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Cleveland, Ohio, 44195, United States
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Portland, Oregon, 97239, United States
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Houston, Texas, 77030, United States
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Salt Lake City, Utah, 84112, United States
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Charlottesville, Virginia, 22908, United States
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Seattle, Washington, 98109, United States
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North Sydney, New South Wales, 2060, Australia
Local Institution
Westmead, New South Wales, 2145, Australia
Local Institution
Greenslopes, Queensland, 4120, Australia
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Woolloongabba, Queensland, 4120, Australia
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Adelaide, South Australia, 5000, Australia
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Hobart, Tasmania, 7000, Australia
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Ballarat, Victoria, 3350, Australia
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Melbourne, Victoria, 3000, Australia
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Melbourne, Victoria, 3004, Australia
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Doubleview, Western Australia, 6018, Australia
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Nedlands, Western Australia, 6009, Australia
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Graz, 803 6, Austria
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Innsbruck, 6020, Austria
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Salzburg, 5020, Austria
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Sankt Pölten, 3100, Austria
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Vienna, A-1090, Austria
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Wilrijk, 2610, Belgium
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Fortaleza, Ceará, 60135237, Brazil
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BrasÃlia, Federal District, 70200-730, Brazil
Local Institution
Curitiba, Paraná, 80530-010, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Local Institution
Florianópolis, Santa Catarina, 88034-000, Brazil
Local Institution
São José do Rio Preto, São Paulo, 15092-415, Brazil
Local Institution
Rio de Janeiro, 20220-410, Brazil
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São Paulo, 01246-000, Brazil
Local Institution
São Paulo, 05308-020, Brazil
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Aarhus, 8200, Denmark
Local Institution
Herlev, 2730, Denmark
Local Institution
Odense C, 2000, Denmark
Local Institution
Bordeaux, 33075, France
Local Institution
Dijon, 21079, France
Local Institution
Lille, 59000, France
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Marseille, 13385, France
Local Institution
Nantes, 44093, France
Local Institution
Nice, 6200, France
Local Institution
Paris, 75010, France
Local Institution
Pierre-Bénite, 69495, France
Local Institution
Rennes, 35000, France
Local Institution
Sr Priest En Jarez, 42270, France
Local Institution
Toulouse, 31059, France
Local Institution
Villejuif, 94800, France
Local Institution
Berlin, 10117, Germany
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Erlangen, 91054, Germany
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Essen, 45122, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Kiel, 24105, Germany
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Lübeck, 23538, Germany
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Mainz, 55131, Germany
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Regensburg, 93053, Germany
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Tübingen, 72076, Germany
Local Institution
Würzburg, 97080, Germany
Local Institution
Bergamo, 24127, Italy
Local Institution
Meldola, 47014, Italy
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Napoli, 80131, Italy
Local Institution
Novara, 28100, Italy
Local Institution
Padua, 35128, Italy
Local Institution
Pavia, 27100, Italy
Local Institution
Amsterdam, 1066CX, Netherlands
Local Institution
Amsterdam, 1081 HV, Netherlands
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Breda, 4818 CK, Netherlands
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Geleen, 6162bg, Netherlands
Local Institution
Leiden, 2333 ZA, Netherlands
Local Institution
Rotterdam, 3075 EA, Netherlands
Local Institution
Utrecht, 3584CX, Netherlands
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Krakow, 31-115, Poland
Local Institution
Warsaw, 02-781, Poland
Local Institution
Wroclaw, 53-413, Poland
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Krasnodar, 350000, Russia
Local Institution
Ryazan, 390011, Russia
Local Institution
Saint Petersburg, 197758, Russia
Local Institution
Saint Petersburg, 198255, Russia
Local Institution
Barcelona, 08036, Spain
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Haddon Heights, 8035, Spain
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Madrid, 28007, Spain
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Málaga, 29010, Spain
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Oviedo, 33011, Spain
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Santiago de Compostela, 15706, Spain
Local Institution
Seville, 41009, Spain
Local Institution
Vaxjo, 352 34, Sweden
Local Institution
Zurich, CH - 8091, Switzerland
Local Institution
Cambridge, CB2 0QQ, United Kingdom
Local Institution
Glasgow, G12 0YN, United Kingdom
Local Institution
Guildford, GU2 7XX, United Kingdom
Local Institution
Leeds, LS9 7TF, United Kingdom
Local Institution
London, SE1 9RT, United Kingdom
Local Institution
London, SW3 6JJ, United Kingdom
Local Institution
Manchester, M20 4BX, United Kingdom
Local Institution
Northwood, HA6 2RN, United Kingdom
Local Institution
Oxford, OX3 7LE, United Kingdom
Local Institution
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.
PMID: 36648215DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2020
First Posted
July 31, 2020
Study Start
March 31, 2021
Primary Completion
February 28, 2024
Study Completion (Estimated)
October 23, 2027
Last Updated
March 19, 2021
Record last verified: 2021-03