Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma

NCT02599402 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-4012015-001274-17
• Study Type: interventional
• Target: 533
• Locations: 11 countries
• Sites: 93

Brief Summary

The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events

  Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

  From first dose to 30 days after last dose (up to approximately 37 months)

Secondary Outcomes (11)

• Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events

  From first dose to 30 days after last dose (up to approximately 37 months)

• Median Time to Onset (Grades 3-4) of Select Adverse Events

  From first dose to 30 days after last dose (up to approximately 37 months)

• Median Time to Resolution (Grades 3-4) of Select Adverse Events

  From first dose to 30 days after last dose (up to approximately 37 months)

• Time to Resolution of an Adverse Event (AE)

  From first dose to 30 days after last dose (up to approximately 37 months)

• Overall Survival (OS)

  Up to approximately 37 months

Study Arms (2)

Combination therapy: Nivolumab + Ipilimumab

EXPERIMENTAL

Nivolumab + Ipilimumab specified dose on specified days

Drug: Nivolumab; Drug: Ipilimumab

Monotherapy: Nivolumab

EXPERIMENTAL

Nivolumab specified dose on specified days

Drug: Nivolumab

Interventions

Nivolumab DRUG

Combination therapy: Nivolumab + Ipilimumab; Monotherapy: Nivolumab

Ipilimumab DRUG

Combination therapy: Nivolumab + Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects must have advanced Melanoma (stage III or IV as confirmed by biopsy) with spread to other sites in the body and unable to be removed by surgery.
• Potential subjects must be newly diagnosed with advanced melanoma and received no treatment for the advanced disease.
• NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs must be discontinued 6 months prior to study entry and the side effects related to the prior therapy resolved.
• Potential subjects (with disease spread to brain) who previously received primary treatment are permitted if there was no evidence of disease as confirmed by the MRI (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the first dose of the study drug). Potential subjects must not have received intravenous steroid treatment (\>10 mg/day) intravenously for at least 2 weeks prior to study drug administration.

You may not qualify if:

• Leptomenigeal metastases
• Subjects with autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• All side effects from previous primary treatments other than alopecia, fatigue, or peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (111)

Local Institution

Garran, Australian Capital Territory, 2605, Australia

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Camperdown, New South Wales, 2050, Australia

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Coffs Harbour, New South Wales, 2450, Australia

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Gateshead, New South Wales, 2290, Australia

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North Sydney, New South Wales, 2060, Australia

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Tiwi, Northern Territory, 0810, Australia

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Brisbane, Queensland, 4102, Australia

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Cairns, Queensland, 4870, Australia

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Greenslopes, Queensland, 4120, Australia

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Southport, Queensland, 4215, Australia

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Adelaide, South Australia, 5000, Australia

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Bedford Park, South Australia, 5402, Australia

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Hobart, Tasmania, 7000, Australia

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Melbourne, Victoria, 3004, Australia

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Melbourne, Victoria, 3128, Australia

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Melbourne, Victoria, 3144, Australia

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Murdoch, Western Australia, 6150, Australia

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Nedlands, Western Australia, 6009, Australia

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Salzburg, 5020, Austria

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Vienna, 1090, Austria

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Brussels, 1090, Belgium

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Brussels, 1200, Belgium

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Helsinki, 00290, Finland

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Oulu, 90029, Finland

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Tampere, 33520, Finland

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Turku, FIN-20520, Finland

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Angers, 49933, France

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Bordeaux, 33075, France

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Boulogne-Billancourt, 92104, France

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Clermont-Ferrand, 63003, France

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Dijon, 21079, France

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Grenoble, 38043, France

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Le Mans, 72037, France

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Lille, 59037, France

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Marseille, 13385, France

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Montpellier, 34295, France

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Nantes, 44093, France

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Nice, 06202, France

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Paris, 75010, France

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Pierre Benite Cedax, 69495, France

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Rennes, 35042, France

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Rouen, 76031, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54511, France

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Villejuif, 94805, France

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Mainz, Rhineland-palladium, 55131, Germany

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Berlin, 10117, Germany

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Dresden, 01277, Germany

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Erfurt, 99028, Germany

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Erlangen, 91054, Germany

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Frankfurt, 60590, Germany

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Freiburg im Breisgau, 79104, Germany

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Göttingen, 37075, Germany

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Hanover, 30625, Germany

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Kiel, 24105, Germany

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Leipzig, 04103, Germany

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Ludwigshafen, 67063, Germany

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Lübeck, 23538, Germany

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Mannheim, 68167, Germany

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Regensburg, 93053, Germany

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Schwerin, 19049, Germany

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Stade, 21682, Germany

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Cork, Ireland

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Dublin, 4, Ireland

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Dublin, 7, Ireland

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Dublin, 8, Ireland

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Dublin, 9, Ireland

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Galway, ST4 6QG, Ireland

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Bari, 70124, Italy

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Bergamo, 24127, Italy

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Genova, 16132, Italy

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Meldola, 47014, Italy

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Milan, 20141, Italy

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Milan, 20133, Italy

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Napoli, 80131, Italy

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Padua, 35128, Italy

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Pisa, 56126, Italy

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Roma, 00144, Italy

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Roma, Italy

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Siena, 53100, Italy

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Terni, 05100, Italy

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Torino, 10126, Italy

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Oslo, 0424, Norway

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Stavanger, 4011, Norway

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Eskilstuna, 631 88, Sweden

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Gävle, SE-80187, Sweden

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Karlskrona, 371 85, Sweden

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Linköping, SE-58185, Sweden

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Stockholm, 17176, Sweden

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Sundsvall, 164 40, Sweden

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Vaxjo, SE-35185, Sweden

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Västerås, 721 89, Sweden

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Basel, 4031, Switzerland

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Lausanne, 1005, Switzerland

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London, Greater London, SW3 6JJ, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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Headington, OX3 7LE, United Kingdom

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London, SE1 9RT, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Mount Vernon Hospital

Northwood, HA6 2RN, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Preston, PR2 9HT, United Kingdom

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Sheffield, S10 2SJ, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Swansea, SA2 8QA, United Kingdom

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Truro, TR1 3LJ, United Kingdom

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Related Publications (1)

• Dummer R, Corrie P, Gutzmer R, Meniawy TM, Del Vecchio M, Lebbe C, Guida M, Dutriaux C, Dreno B, Meyer N, Ferrucci PF, Dalle S, Khattak MA, Grob JJ, Briscoe K, Larkin J, Mansard S, Lesimple T, Guidoboni M, Sabatini S, Richtig E, Herbst R, Lobo M, Askelson M, Ascierto PA, Maio M. First-Line, Fixed-Duration Nivolumab Plus Ipilimumab Followed by Nivolumab in Clinically Diverse Patient Populations With Unresectable Stage III or IV Melanoma: CheckMate 401. J Clin Oncol. 2023 Aug 10;41(23):3917-3929. doi: 10.1200/JCO.22.02199. Epub 2023 Jun 12.

  PMID: 37307514 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 6, 2015
• Study Start: December 20, 2015
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Locations

AU (4); IE (6); IT (14); DE (17); SE (8); FR (19); BE (2); CH (2); NO (2); GB (15); FI (4)