Melanoma Clinical 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

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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Study ID:

NCT04495010

Recruitment Status:

Withdrawn

Sponsor:

Bristol-Myers Squibb

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There are 116 Locations for this study

See Locations Near You

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Gilbert Arizona, 85234, United States
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Tucson Arizona, 85724, United States
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San Francisco California, 94158, United States
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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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Saint 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
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Westmead New South Wales, 2145, Australia
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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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St. Poelten , 3100, Austria
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Wien , A-109, Austria
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Brussels , 1200, Belgium
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Gent , 9000, Belgium
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Wilrijk , 2610, Belgium
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Fortaleza Ceara, 60135, Brazil
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Brasilia Distrito Federal, 70200, Brazil
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Curitiba Parana, 80530, Brazil
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Porto Alegre RIO Grande DO SUL, 90035, Brazil
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Porto Alegre RIO Grande DO SUL, 90050, Brazil
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Porto Alegre RIO Grande DO SUL, 91350, Brazil
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Florianopolis Santa Catarina, 88034, Brazil
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Sao Jose do Rio Preto SAO Paulo, 15092, Brazil
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Rio De Janeiro , 20220, Brazil
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Sao Paulo , 01246, Brazil
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Sao Paulo , 05308, Brazil
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Aarhus , 8200, Denmark
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Herlev , 2730, Denmark
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Odense C , 2000, Denmark
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Bordeaux , 33075, France
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Dijon , 21079, France
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Lille , 59000, France
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Marseille , 13385, France
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Nantes , 44093, France
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Nice , 6200, France
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Paris , 75010, France
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Pierre-Benite , 69495, France
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Rennes , 35000, France
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Sr Priest En Jarez , 42270, France
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Toulouse , 31059, France
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Villejuif , 94800, France
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Berlin , 10117, Germany
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Erlangen , 91054, Germany
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Essen , 45122, Germany
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Hannover , 30625, Germany
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Heidelberg , 69120, Germany
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Kiel , 24105, Germany
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Luebeck , 23538, Germany
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Mainz , 55131, Germany
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Regensburg , 93053, Germany
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Tuebingen , 72076, Germany
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Wuerzburg , 97080, Germany
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Bergamo , 24127, Italy
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Meldola , 47014, Italy
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Napoli , 80131, Italy
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Novara , 28100, Italy
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Padova , 35128, Italy
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Pavia , 27100, Italy
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Amsterdam , 1066C, Netherlands
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Amsterdam , 1081 , Netherlands
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Breda , 4818 , Netherlands
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Geleen , 6162b, Netherlands
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Leiden , 2333 , Netherlands
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Rotterdam , 3075 , Netherlands
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Utrecht , 3584C, Netherlands
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Krakow , 31-11, Poland
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Warszawa , 02-78, Poland
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Wroclaw , 53-41, Poland
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Krasnodar , 35000, Russian Federation
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Ryazan , 39001, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Saint-Petersburg , 19825, Russian Federation
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Barcelona , 08036, Spain
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Haddon Heights , 8035, Spain
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Madrid , 28007, Spain
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Malaga , 29010, Spain
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Oviedo , 33011, Spain
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Santiago de Compostela , 15706, Spain
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Sevilla , 41009, Spain
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Vaxjo , 352 3, Sweden
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Zuerich , CH - , Switzerland
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Cambridge , CB2 0, United Kingdom
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Glasgow , G12 0, United Kingdom
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Guildford , GU2 7, United Kingdom
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Leeds , LS9 7, United Kingdom
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London , SE1 9, United Kingdom
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London , SW3 6, United Kingdom
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Manchester , M20 4, United Kingdom
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Northwood , HA6 2, United Kingdom
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Oxford , OX3 7, United Kingdom
Local Institution
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Study ID:

NCT04495010

Recruitment Status:

Withdrawn

Sponsor:


Bristol-Myers Squibb

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