Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

NCT01844505 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-0672012-005371-13
• Study Type: interventional
• Target: 945
• Locations: 21 countries
• Sites: 136

Brief Summary

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

Conditions

Unresectable or Metastatic Melanoma

Outcome Measures

Primary Outcomes (4)

• Progression Free Survival (PFS)

  PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Particpants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.

  From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)

• Overall Survival (OS)

  OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

  From randomization to date of death (Assessed up to September 2016, approximately 39 months)

• Rate of Overall Survival

  OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. The overall survival rate at time T (6, 12, or 24 months) was defined as the probability that a participant was alive at time T following randomization.

  24 months

• Rate of Progression-Free Survival

  PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.

  24 months

Secondary Outcomes (11)

• Progression Free Survival (PFS)

  From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)

• Overall Survival (OS)

  From randomization until death (assessed up to approximately 128 months)

• Objective Response Rate (ORR) Per Investigator Assessment

  From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)

• Progression-Free Survival Based on PD-L1 Expression Level

  From randomization until disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months)

• Overall Survival Based on PD-L1 Expression Level

  From randomization until death (assessed up to approximately 128 months)

Study Arms (3)

Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab

EXPERIMENTAL

Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Ipilimumab 0 mg/kg solution intravenously on weeks 1, 4 and Placebo matching with Nivolumab on weeks 4 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Biological: Nivolumab; Biological: Placebo for Nivolumab; Biological: Placebo for Ipilimumab

Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab

EXPERIMENTAL

Nivolumab 1 mg/kg solution intravenously combined with Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Nivolumab on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Biological: Nivolumab; Biological: Ipilimumab; Biological: Placebo for Nivolumab

Arm C: Ipilimumab+Placebo for Nivolumab

EXPERIMENTAL

Ipilimumab 3 mg/kg solution intravenously every 3 weeks for a total of 4 doses plus Placebo matching with Nivolumab 0 mg/kg solution intravenously on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends (Placebo matching with Nivolumab is no longer required)

Biological: Ipilimumab; Biological: Placebo for Nivolumab

Interventions

Nivolumab BIOLOGICAL

Also known as: BMS-936558, MDX-1106

Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab; Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab

Ipilimumab BIOLOGICAL

Also known as: Yervoy, BMS-734016, MDX-010

Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab; Arm C: Ipilimumab+Placebo for Nivolumab

Placebo for Nivolumab BIOLOGICAL

Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab; Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab; Arm C: Ipilimumab+Placebo for Nivolumab

Placebo for Ipilimumab BIOLOGICAL

Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed stage III (unresectable) or stage IV melanoma
• Treatment naïve patients
• Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
• Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

You may not qualify if:

• Active brain metastases or leptomeningeal metastases
• Ocular melanoma
• Subjects with active, known or suspected autoimmune disease
• Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
• Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (150)

Local Institution - 0085

Gilbert, Arizona, 85234, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Local Institution - 0046

La Jolla, California, 92093-0698, United States

Location

Local Institution - 0053

Los Angeles, California, 90025, United States

Location

Local Institution - 0014

Los Angeles, California, 90095, United States

Location

Comprehensive Cancer Center At Desert Regional Medical Ctr

Palm Springs, California, 92262, United States

Location

Local Institution - 0066

Rancho Mirage, California, 92270, United States

Location

California Pacific Medical Center Research Institute

San Francisco, California, 94115, United States

Location

Local Institution - 0049

San Francisco, California, 94143, United States

Location

Local Institution - 0052

Aurora, Colorado, 80045, United States

Location

Local Institution - 0084

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0098

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution - 0183

Washington D.C., District of Columbia, 20010, United States

Location

Local Institution - 0042

Jacksonville, Florida, 32207, United States

Location

Local Institution - 0008

Orlando, Florida, 32806, United States

Location

Local Institution - 0051

Atlanta, Georgia, 30322, United States

Location

Maine Center For Cancer Medicine

Scarborough, Maine, 04074, United States

Location

Local Institution - 0080

Lutherville, Maryland, 21093, United States

Location

Local Institution - 0081

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0082

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0083

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0087

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0187

Minneapolis, Minnesota, 55407, United States

Location

Local Institution - 0065

Jackson, Mississippi, 39216, United States

Location

Local Institution - 0067

St Louis, Missouri, 63110, United States

Location

Local Institution - 0015

Las Vegas, Nevada, 89148, United States

Location

Local Institution - 0188

Morristown, New Jersey, 07962, United States

Location

Local Institution - 0068

Albuquerque, New Mexico, 87106, United States

Location

Local Institution - 0079

Albany, New York, 12206, United States

Location

Local Institution - 0174

New York, New York, 10016, United States

Location

Local Institution - 0070

New York, New York, 10020, United States

Location

Local Institution - 0047

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0048

Durham, North Carolina, 27710, United States

Location

Local Institution - 0007

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0045

Portland, Oregon, 97213, United States

Location

Local Institution - 0061

Allentown, Pennsylvania, 18102, United States

Location

Local Institution - 0112

Bethlehem, Pennsylvania, 18015, United States

Location

Local Institution - 0069

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 0154

Greenville, South Carolina, 29605, United States

Location

Local Institution - 0062

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0064

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0044

Dallas, Texas, 75246, United States

Location

Texas Oncology

Dallas, Texas, 75246, United States

Location

Local Institution - 0088

Houston, Texas, 77210, United States

Location

Local Institution - 0089

Salt Lake City, Utah, 84112, United States

Location

Local Institution - 0054

Seattle, Washington, 98109, United States

Location

Local Institution - 0017

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0031

Coffs Harbour, New South Wales, 2450, Australia

Location

Local Institution - 0028

Gateshead, New South Wales, 2290, Australia

Location

Local Institution - 0023

Macquarie University, New South Wales, 2109, Australia

Location

Local Institution - 0138

North Sydney, New South Wales, 2060, Australia

Location

Local Institution - 0019

Brisbane, Queensland, 4120, Australia

Location

Local Institution - 0022

Southport, Queensland, 4215, Australia

Location

Local Institution - 0018

Woolloongabba, Queensland, 4102, Australia

Location

Local Institution - 0020

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0025

Kurralta Park, South Australia, 5037, Australia

Location

Local Institution - 0024

Box Hill, Victoria, 3128, Australia

Location

Local Institution - 0016

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0026

Melbourne, Victoria, 3000, Australia

Location

Local Institution - 0021

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0148

Salzburg, 5020, Austria

Location

Local Institution - 0145

Vienna, 1090, Austria

Location

Local Institution - 0003

Brussels, 1090, Belgium

Location

Local Institution - 0002

Brussels, 1200, Belgium

Location

Local Institution - 0004

Edegem, 2650, Belgium

Location

Local Institution - 0005

Ghent, 9000, Belgium

Location

Local Institution - 0103

Leuven, 3000, Belgium

Location

Local Institution - 0140

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0165

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0141

London, Ontario, N6A 4L6, Canada

Location

Local Institution - 0143

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 0166

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0139

Montreal, Quebec, H2X 3E4, Canada

Location

Local Institution - 0142

Québec, Quebec, G1J 1Z4, Canada

Location

Local Institution - 0092

Brno, 656 53, Czechia

Location

Local Institution - 0091

Hradec Králové, 500 05, Czechia

Location

Local Institution - 0090

Prague, 128 08, Czechia

Location

Local Institution - 0167

Prague, 180 81, Czechia

Location

Local Institution - 0076

Aarhus, 8200, Denmark

Location

Local Institution - 0078

Herlev, 2730, Denmark

Location

Local Institution - 0077

Odense, 5000, Denmark

Location

Local Institution - 0071

Helsinki, Uusimaa, 00290, Finland

Location

Local Institution - 0169

Tampere, 33521, Finland

Location

Local Institution - 0125

Boulogne-Billancourt, 92104, France

Location

Local Institution - 0126

Marseille, 13385, France

Location

Local Institution - 0056

Nantes, 44093, France

Location

Local Institution - 0058

Paris, 75475, France

Location

Local Institution - 0124

Pierre-Bénite, 69310, France

Location

Local Institution - 0127

Rennes, 35042, France

Location

Local Institution

Villejuif, 94805, France

Location

Local Institution - 0162

Buxtehude, 21614, Germany

Location

Local Institution - 0161

Erfurt, 99089, Germany

Location

Local Institution - 0171

Erlangen, 91054, Germany

Location

Local Institution - 0156

Essen, 45147, Germany

Location

Local Institution - 0159

Hanover, 30625, Germany

Location

Local Institution - 0157

Heidelberg, 69120, Germany

Location

Local Institution - 0158

Kiel, 24105, Germany

Location

Local Institution - 0178

Leipzig, 04103, Germany

Location

Local Institution - 0160

München, 80337, Germany

Location

Local Institution - 0134

Tübingen, 72076, Germany

Location

Local Institution - 0035

Dublin, Dublin, Ireland

Location

Local Institution - 0033

Cork, T12DFK4, Ireland

Location

Local Institution - 0168

Dublin, 01, Ireland

Location

Local Institution - 0036

Dublin, 7, Ireland

Location

Local Institution - 0034

Dublin, Ireland

Location

Local Institution - 0032

Galway, 0, Ireland

Location

Local Institution - 0120

Jerusalem, 91120, Israel

Location

Local Institution - 0121

Tel Litwinsky, 52621, Israel

Location

Local Institution - 0176

Bergamo, 24127, Italy

Location

Local Institution - 0115

Genova, 16132, Italy

Location

Local Institution - 0113

Meldola (FC), 47014, Italy

Location

Local Institution - 0172

Milan, 20133, Italy

Location

Local Institution - 0117

Milan, 20141, Italy

Location

Local Institution - 0114

Napoli, 80131, Italy

Location

Local Institution - 0118

Padua, Padova, Italy

Location

Local Institution - 0177

Roma, 00144, Italy

Location

Local Institution - 0116

Siena, 53100, Italy

Location

Local Institution - 0010

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 0012

Leiden, 2333 ZA, Netherlands

Location

Local Institution - 0013

Nijmegen, 6525 GC, Netherlands

Location

Local Institution - 0029

Auckland, 1142, New Zealand

Location

Local Institution - 0123

Oslo, 0424, Norway

Location

Local Institution - 0109

Gdansk, 80-952, Poland

Location

Local Institution - 0133

Krakow, 31-115, Poland

Location

Local Institution - 0060

Lodz, 93-513, Poland

Location

Local Institution - 0059

Warsaw, 02-781, Poland

Location

Local Institution - 0130

Moscow, 115478, Russia

Location

Local Institution - 0132

Saint Petersburg, 197758, Russia

Location

Local Institution - 0128

Saint Petersburg, 198255, Russia

Location

Local Institution - 0131

Samara, 443031, Russia

Location

Local Institution - 0152

Badalona-Barcelona, 08916, Spain

Location

Local Institution - 0151

Barcelona, 08035, Spain

Location

Local Institution - 0175

Barcelona, 08036, Spain

Location

Local Institution - 0150

Madrid, 28007, Spain

Location

Local Institution - 0149

Madrid, 28046, Spain

Location

Local Institution - 0153

Málaga, 29010, Spain

Location

Local Institution - 0147

Pamplona, 31008, Spain

Location

Local Institution - 0182

Gothenberg, 413 45, Sweden

Location

Local Institution - 0184

Stockholm, 171 76, Sweden

Location

Local Institution - 0164

Geneva, 1211, Switzerland

Location

Local Institution - 0189

Lausanne, 1011, Switzerland

Location

Local Institution - 0186

Sankt Gallen, 9007, Switzerland

Location

Local Institution - 0163

Zurich, 8091, Switzerland

Location

Local Institution - 0039

Glasgow, Dumfries & Galloway, G12 0YN, United Kingdom

Location

Local Institution - 0038

London, Greater London, SW3 6JJ, United Kingdom

Location

Local Institution - 0119

Manchester, Greater Manchester, M20 4XB, United Kingdom

Location

Local Institution - 0041

Northwood, Middlesex, HA6 2JR, United Kingdom

Location

Local Institution - 0122

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Local Institution - 0037

Cambridge, CB2 2QQ, United Kingdom

Location

Local Institution - 0040

Swansea, SA2 8QA, United Kingdom

Location

Related Publications (10)

• 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

• Wolchok JD, Chiarion-Sileni V, Rutkowski P, Cowey CL, Schadendorf D, Wagstaff J, Queirolo P, Dummer R, Butler MO, Hill AG, Postow MA, Gaudy-Marqueste C, Medina T, Lao CD, Walker J, Marquez-Rodas I, Haanen JBAG, Guidoboni M, Maio M, Schoffski P, Carlino MS, Sandhu S, Lebbe C, Ascierto PA, Long GV, Ritchings C, Nassar A, Askelson M, Benito MP, Wang W, Hodi FS, Larkin J; CheckMate 067 Investigators. Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma. N Engl J Med. 2025 Jan 2;392(1):11-22. doi: 10.1056/NEJMoa2407417. Epub 2024 Sep 15.

  PMID: 39282897 DERIVED

• Mantia CM, Werner L, Stwalley B, Ritchings C, Tarhini AA, Atkins MB, McDermott DF, Regan MM. Sensitivity of treatment-free survival to subgroup analyses in patients with advanced melanoma treated with immune checkpoint inhibitors. Melanoma Res. 2022 Feb 1;32(1):35-44. doi: 10.1097/CMR.0000000000000793.

  PMID: 34855329 DERIVED

• Wolchok JD, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Butler MO, Hill A, Marquez-Rodas I, Haanen JBAG, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bas T, Ritchings C, Larkin J, Hodi FS. Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma. J Clin Oncol. 2022 Jan 10;40(2):127-137. doi: 10.1200/JCO.21.02229. Epub 2021 Nov 24.

  PMID: 34818112 DERIVED

• Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Marquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28.

  PMID: 31562797 DERIVED

• Hodi FS, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Cowey CL, Lao CD, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hill A, Hogg D, Marquez-Rodas I, Jiang J, Rizzo J, Larkin J, Wolchok JD. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1480-1492. doi: 10.1016/S1470-2045(18)30700-9. Epub 2018 Oct 22.

  PMID: 30361170 DERIVED

• Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao CD, Wagstaff J, Schadendorf D, Ferrucci PF, Smylie M, Dummer R, Hill A, Hogg D, Haanen J, Carlino MS, Bechter O, Maio M, Marquez-Rodas I, Guidoboni M, McArthur G, Lebbe C, Ascierto PA, Long GV, Cebon J, Sosman J, Postow MA, Callahan MK, Walker D, Rollin L, Bhore R, Hodi FS, Larkin J. Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2017 Oct 5;377(14):1345-1356. doi: 10.1056/NEJMoa1709684. Epub 2017 Sep 11.

  PMID: 28889792 DERIVED

• Long GV, Weber JS, Larkin J, Atkinson V, Grob JJ, Schadendorf D, Dummer R, Robert C, Marquez-Rodas I, McNeil C, Schmidt H, Briscoe K, Baurain JF, Hodi FS, Wolchok JD. Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials. JAMA Oncol. 2017 Nov 1;3(11):1511-1519. doi: 10.1001/jamaoncol.2017.1588.

  PMID: 28662232 DERIVED

• Schadendorf D, Larkin J, Wolchok J, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao C, Wagstaff J, Callahan MK, Postow MA, Smylie M, Ferrucci PF, Dummer R, Hill A, Taylor F, Sabater J, Walker D, Kotapati S, Abernethy A, Long GV. Health-related quality of life results from the phase III CheckMate 067 study. Eur J Cancer. 2017 Sep;82:80-91. doi: 10.1016/j.ejca.2017.05.031. Epub 2017 Jun 23.

  PMID: 28651159 DERIVED

• Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31.

  PMID: 26027431 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

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: April 29, 2013
• First Posted: May 1, 2013
• Study Start: June 11, 2013
• Primary Completion: August 1, 2016
• Study Completion: April 19, 2024
• Last Updated: May 21, 2025
• Results First Posted: September 26, 2017

Record last verified: 2025-05

Locations

SE (2); US (46); NZ (1); AU (2); PL (4); CZ (4); CA (7); IL (2); IT (9); FR (7); NO (1); DK (3); ES (7); GB (7); IE (6); BE (5); FI (2); NL (3); CH (4); RU (4); DE (10)