A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

NCT02714218 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CA209-511
• Study Type: interventional
• Target: 387
• Locations: 13 countries
• Sites: 57

Brief Summary

The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs)

  The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.

  From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months)

Secondary Outcomes (18)

• Objective Response Rate (ORR)

  From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years)

• Overall Survival (OS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years)

• Progression Free Survival (PFS)

  From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years)

• Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale

  Weeks 7, 16, 20, 24, 28, 32, 36, 40

• Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale

  Weeks 7, 16, 20, 24, 28, 32, 36, 40

Study Arms (3)

Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV

EXPERIMENTAL

Specified dose on specified days

Biological: Nivolumab 3 mg/kg IV; Biological: Ipilimumab 1 mg/kg IV

Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV

EXPERIMENTAL

Specified dose on specified days

Biological: Nivolumab 1 mg/kg IV; Biological: Ipilimumab 3 mg/kg IV

Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg

EXPERIMENTAL

Specified dose on specified days

Biological: Ipilimumab 1 mg/kg IV; Biological: Nivolumab 6 mg/kg IV

Interventions

Nivolumab 3 mg/kg IV BIOLOGICAL

Followed by Nivolumab monotherapy

Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV

Ipilimumab 1 mg/kg IV BIOLOGICAL

Followed by Nivolumab monotherapy

Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV; Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg

Nivolumab 1 mg/kg IV BIOLOGICAL

Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV

Ipilimumab 3 mg/kg IV BIOLOGICAL

Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV

Nivolumab 6 mg/kg IV BIOLOGICAL

A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to \~ 480mg.

Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg

Eligibility Criteria

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

You may qualify if:

• Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma \[per American Joint Committee on Cancer (AJCC) staging system\] that is unresectable or metastatic
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma

You may not qualify if:

• Subjects with active brain metastases or leptomeningeal metastases
• Subjects with ocular melanoma
• Subjects with active, known or suspected autoimmune disease

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (57)

University Of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Allina Health

Fridley, Minnesota, 55432, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

University Of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Local Institution

North Sydney, New South Wales, 2060, Australia

Location

Local Institution - 0045

Waratah, New South Wales, 2298, Australia

Location

Local Institution

Greenslopes, Queensland, 4120, Australia

Location

Local Institution

Melbourne, Victoria, 3004, Australia

Location

Local Institution - 0007

Edmonton, Alberta, T6G 1Z2, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

CHU de Quebec - Universite Laval

Québec, Quebec, G1R 2J6, Canada

Location

Local Institution - 0063

Aarhus N, 8200, Denmark

Location

Local Institution - 0065

Herlev, 2730, Denmark

Location

Local Institution - 0064

Odense, 5000, Denmark

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Chru De Lille

Lille, 59037, France

Location

Hopital De La Timone

Marseille, 13385, France

Location

Hopital Hotel Dieu

Nantes, 44093, France

Location

Hopital Saint Louis

Paris, 75475, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

Local Institution - 0019

Villejuif, 94805, France

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Ludwig-Maximilians-Universitaet

München, 80337, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

Local Institution

Ramat Gan, 5262100, Israel

Location

Local Institution - 0039

Bergamo, 24127, Italy

Location

Local Institution - 0042

Milan, 20133, Italy

Location

Local Institution - 0040

Napoli, 80131, Italy

Location

Istituto Oncologico Veneto IOV

Padua, 35128, Italy

Location

Local Institution - 0041

Siena, 53100, Italy

Location

Ospedale San Vincenzo

Taormina, 98039, Italy

Location

Local Institution - 0052

Amsterdam, 1066 CX, Netherlands

Location

Local Institution

Amsterdam, 1081 HV, Netherlands

Location

University Medical Center Groningen (Umcg)

Groningen, 9700RB, Netherlands

Location

Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote

Gdansk, 80-214, Poland

Location

Klinika Nowotworow Ukladowych i Uogolnionych

Krakow, 31-115, Poland

Location

Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

Warsaw, 02-781, Poland

Location

Local Institution

Moscow, 115478, Russia

Location

Local Institution

Badalona-barcelona, 08916, Spain

Location

Local Institution - 0024

Barcelona, 08036, Spain

Location

Local Institution

Madrid, 28007, Spain

Location

Local Institution - 0027

Madrid, 28034, Spain

Location

Local Institution

San Sabastian Gipuzkoa, 20014, Spain

Location

Local Institution

Valencia, 46014, Spain

Location

Local Institution

Manchester, Greater Manchester, M20 4XB, United Kingdom

Location

Local Institution

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Local Institution

Guildford, GU2 7XX, United Kingdom

Location

Local Institution

London, SW3 6JJ, United Kingdom

Location

Related Publications (2)

• Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6.

  PMID: 39504507 DERIVED

• Lebbe C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J. Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27.

  PMID: 30811280 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 21, 2016
• Study Start: April 4, 2016
• Primary Completion: April 20, 2017
• Study Completion: May 28, 2021
• Last Updated: June 24, 2022
• Results First Posted: April 23, 2019

Record last verified: 2022-06

Locations

IL (1); PL (3); CA (3); NL (3); DE (4); DK (3); IT (6); ES (6); GB (4); US (11); FR (8); AU (4); RU (1)