Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

NCT01515189 | Completed Phase 3 Results DMC

• 2 other identifiers: CA184-1692011-004029-28
• Study Type: interventional
• Target: 831
• Locations: 21 countries
• Sites: 82

Brief Summary

The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.

  Approximately 48 months (assessed up to February 2016)

Secondary Outcomes (7)

• Progression Free Survival (PFS) by mWHO Criteria

  From date of randomization until 540 death events occurred (approximately 48 months)

• Best Overall Response Rate (BORR) by mWHO Criteria

  From date of randomization until 540 death events occurred (approximately 48 months)

• Disease Control Rate (DCR) by mWHO Criteria

  From date of randomization until 540 death events occurred (approximately 48 months)

• Duration of Response (DOR) by mWHO Criteria

  From date of randomization until 540 death events occurred (approximately 48 months)

• Duration of Stable Disease by mWHO Criteria

  From date of randomization until 540 death events occurred (approximately 48 months)

Study Arms (2)

Arm 1: Ipilimumab (3 mg/kg)

EXPERIMENTAL

Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity

Biological: Ipilimumab

Arm 2: Ipilimumab (10 mg/kg)

EXPERIMENTAL

Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity

Biological: Ipilimumab

Interventions

Ipilimumab BIOLOGICAL

Also known as: Yervoy, BMS-734016

Arm 1: Ipilimumab (3 mg/kg); Arm 2: Ipilimumab (10 mg/kg)

Eligibility Criteria

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

You may qualify if:

• Unresectable Stage III or Stage IV melanoma
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if:

• Brain metastases with symptoms or requiring treatment
• History of autoimmune disease

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (88)

The Angeles Clinic And Research Institute

Los Angeles, California, 90025, United States

Location

University Of California Los Angeles

Los Angeles, California, 90095, United States

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Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

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Orlando Health, Inc

Orlando, Florida, 32806, United States

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Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

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Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

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Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

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Duke University Hospital

Durham, North Carolina, 27710, United States

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Providence Portland Medical Center

Portland, Oregon, 97213, United States

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St. Luke's Cancer Center - Anderson Campus

Easton, Pennsylvania, 18045, United States

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Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

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Local Institution

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Fundacion Cidea

Buenos Aires, 1121, Argentina

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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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Brisbane, Queensland, 4102, Australia

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Southport, Queensland, 4215, Australia

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Adelaide, South Australia, 5000, Australia

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Heidelberg, Victoria, 3084, Australia

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Linz, 4020, Austria

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Vienna, 1090, Austria

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Brussels, 1200, Belgium

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Leuven, 3000, Belgium

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Edmonton, Alberta, T6G 1Z2, Canada

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Halfax, Nova Scotia, B3H 2Y9, Canada

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Montreal, Quebec, H2W1S6, Canada

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Brno, 656 53, Czechia

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Olomouc, 775 20, Czechia

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Prague, 128 08, Czechia

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Aarhus, 8000, Denmark

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Herlev, 2730, Denmark

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Odense, 5000, Denmark

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Bordeaux, 33075, France

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Dijon, 21079, France

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Grenoble, 38043, France

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Lille, 59037, France

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Marseille, 13385, France

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Nantes, 44093, France

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Paris, 75010, France

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Pierre-Bénite, 69495, France

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Reims, 51092, France

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Toulouse, 31059, France

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Villejuif, 94805, France

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Buxtehude, 21614, Germany

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Essen, 45122, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Kiel, 24105, Germany

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Mainz, 55131, Germany

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Munich, 81675, Germany

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Tübingen, 72076, Germany

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Budapest, 1122, Hungary

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Kaposvár, 7400, Hungary

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Szeged, 6720, Hungary

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Jerusalem, 71908, Israel

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Meldola (fc), 47014, 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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Roma, 00144, Italy

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Siena, 53100, Italy

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Leon, Guanajato, Guanajuato, 37000, Mexico

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Amsterdam, 1081 HV, Netherlands

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Groningen, 9713 GZ, Netherlands

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Leiden, 2300 RC, Netherlands

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Bergen, 5021, Norway

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Oslo, 0379, Norway

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Gdansk, 80-219, Poland

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Poznan, 60-693, Poland

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Warsaw, 02-781, Poland

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Cape Town, Western Cape, 7570, South Africa

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George, Western Cape, 6530, South Africa

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Rondebosch, Western Cape, 7700, South Africa

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Barcelona, 08036, Spain

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Barcelona, 08908, Spain

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Madrid, 28041, Spain

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Navarra, 31008, Spain

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Instituto Valenciano De Oncologia

Valencia, 46009, Spain

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Valencia, 46014, Spain

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Gothenberg, 413 45, Sweden

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Lund, 221 85, Sweden

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Stockholm, 171 76, Sweden

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Umeå, 901 85, Sweden

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Lausanne, 1011, Switzerland

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Manchester, Greater Manchester, M20 4BX, United Kingdom

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Glasgow, Scotland, Strathclyde, G12 OYN, United Kingdom

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London, SW3 6JJ, United Kingdom

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Swansea, SA2 8QA, United Kingdom

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Related Publications (3)

• Ascierto PA, Del Vecchio M, Mackiewicz A, Robert C, Chiarion-Sileni V, Arance A, Lebbe C, Svane IM, McNeil C, Rutkowski P, Loquai C, Mortier L, Hamid O, Bastholt L, Dreno B, Schadendorf D, Garbe C, Nyakas M, Grob JJ, Thomas L, Liszkay G, Smylie M, Hoeller C, Ferraresi V, Grange F, Gutzmer R, Pikiel J, Hosein F, Simsek B, Maio M. Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma. J Immunother Cancer. 2020 Jun;8(1):e000391. doi: 10.1136/jitc-2019-000391.

  PMID: 32503946 DERIVED

• Feng Y, Wang X, Suryawanshi S, Bello A, Roy A. Linking Tumor Growth Dynamics to Survival in Ipilimumab-Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling. CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):825-834. doi: 10.1002/psp4.12454. Epub 2019 Aug 13.

  PMID: 31334596 DERIVED

• Ascierto PA, Del Vecchio M, Robert C, Mackiewicz A, Chiarion-Sileni V, Arance A, Lebbe C, Bastholt L, Hamid O, Rutkowski P, McNeil C, Garbe C, Loquai C, Dreno B, Thomas L, Grob JJ, Liszkay G, Nyakas M, Gutzmer R, Pikiel J, Grange F, Hoeller C, Ferraresi V, Smylie M, Schadendorf D, Mortier L, Svane IM, Hennicken D, Qureshi A, Maio M. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2017 May;18(5):611-622. doi: 10.1016/S1470-2045(17)30231-0. Epub 2017 Mar 27.

  PMID: 28359784 DERIVED

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Melanoma

Interventions

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

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: January 18, 2012
• First Posted: January 24, 2012
• Study Start: February 17, 2012
• Primary Completion: February 6, 2016
• Study Completion: August 17, 2017
• Last Updated: July 31, 2019
• Results First Posted: March 24, 2017

Record last verified: 2019-07

Locations

NL (3); BE (2); SE (4); FR (11); IT (6); IL (1); PL (3); ZA (3); CZ (3); ES (6); CA (3); AR (2); GB (4); AU (2); HU (3); ME (1); NO (2); DE (8); CH (1); DK (3); US (11)