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.
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
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There are 116 Locations for this study
Gilbert Arizona, 85234, United States
Tucson Arizona, 85724, United States
San Francisco California, 94158, United States
Aurora Colorado, 80045, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Marietta Georgia, 30060, United States
Annapolis Maryland, 21401, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55455, United States
Hattiesburg Mississippi, 39401, United States
Saint Louis Missouri, 63110, United States
Morristown New Jersey, 07960, United States
New Brunswick New Jersey, 08901, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98109, United States
North Sydney New South Wales, 2060, Australia
Westmead New South Wales, 2145, Australia
Greenslopes Queensland, 4120, Australia
Woolloongabba Queensland, 4120, Australia
Adelaide South Australia, 5000, Australia
Hobart Tasmania, 7000, Australia
Ballarat Victoria, 3350, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
Doubleview Western Australia, 6018, Australia
Nedlands Western Australia, 6009, Australia
Graz , 803 6, Austria
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
St. Poelten , 3100, Austria
Wien , A-109, Austria
Brussels , 1200, Belgium
Gent , 9000, Belgium
Wilrijk , 2610, Belgium
Fortaleza Ceara, 60135, Brazil
Brasilia Distrito Federal, 70200, Brazil
Curitiba Parana, 80530, Brazil
Porto Alegre RIO Grande DO SUL, 90035, Brazil
Porto Alegre RIO Grande DO SUL, 90050, Brazil
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Florianopolis Santa Catarina, 88034, Brazil
Sao Jose do Rio Preto SAO Paulo, 15092, Brazil
Rio De Janeiro , 20220, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 05308, Brazil
Aarhus , 8200, Denmark
Herlev , 2730, Denmark
Odense C , 2000, Denmark
Bordeaux , 33075, France
Dijon , 21079, France
Lille , 59000, France
Marseille , 13385, France
Nantes , 44093, France
Nice , 6200, France
Paris , 75010, France
Pierre-Benite , 69495, France
Rennes , 35000, France
Sr Priest En Jarez , 42270, France
Toulouse , 31059, France
Villejuif , 94800, France
Berlin , 10117, Germany
Erlangen , 91054, Germany
Essen , 45122, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Luebeck , 23538, Germany
Mainz , 55131, Germany
Regensburg , 93053, Germany
Tuebingen , 72076, Germany
Wuerzburg , 97080, Germany
Bergamo , 24127, Italy
Meldola , 47014, Italy
Napoli , 80131, Italy
Novara , 28100, Italy
Padova , 35128, Italy
Pavia , 27100, Italy
Amsterdam , 1066C, Netherlands
Amsterdam , 1081 , Netherlands
Breda , 4818 , Netherlands
Geleen , 6162b, Netherlands
Leiden , 2333 , Netherlands
Rotterdam , 3075 , Netherlands
Utrecht , 3584C, Netherlands
Krakow , 31-11, Poland
Warszawa , 02-78, Poland
Wroclaw , 53-41, Poland
Krasnodar , 35000, Russian Federation
Ryazan , 39001, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saint-Petersburg , 19825, Russian Federation
Barcelona , 08036, Spain
Haddon Heights , 8035, Spain
Madrid , 28007, Spain
Malaga , 29010, Spain
Oviedo , 33011, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41009, Spain
Vaxjo , 352 3, Sweden
Zuerich , CH - , Switzerland
Cambridge , CB2 0, United Kingdom
Glasgow , G12 0, United Kingdom
Guildford , GU2 7, United Kingdom
Leeds , LS9 7, United Kingdom
London , SE1 9, United Kingdom
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Northwood , HA6 2, United Kingdom
Oxford , OX3 7, United Kingdom
Sutton , SM2 5, United Kingdom
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