Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

NCT ID: NCT00324155

Last Updated: 2014-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 681 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2013-10-31

Brief Summary

The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine

Detailed Description

For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group

Conditions

Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm A: Ipilimumab and Dacarbazine

In Maintenance phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Maintenance phase

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent

In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression

Dacarbazine

Intervention Type: DRUG

Intravenous solution; intravenous; 850 mg/m\^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent

Arm B: Placebo and Dacarbazine

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent

Dacarbazine

Intervention Type: DRUG

Intravenous solution; intravenous; 850 mg/m\^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent

Interventions

Ipilimumab

Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent

In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression

Intervention Type: DRUG

Placebo

Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent

Intervention Type: DRUG

Dacarbazine

Intravenous solution; intravenous; 850 mg/m\^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent

Intervention Type: DRUG

Other Intervention Names

MDX-010; BMS-734016

Eligibility Criteria

Inclusion Criteria

• Informed Consent
• Measurable Disease
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Lab / imaging requirements
• Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C
• Men and Women > 18 years (16 were allowable)
• Prior therapy restriction (adjuvant only)

Exclusion:

• Pregnant / nursing
• Inadequate contraception
• Brain metastasis
• Primary ocular or mucosal melanoma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medarex

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Pacific Cancer Medical Center

Anaheim, California, United States

Wilshire Oncology Medical Group Inc

La Verne, California, United States

The Angeles Clinic And Research Institute

Los Angeles, California, United States

Comprehensive Cancer Center

Palm Springs, California, United States

Sharp Clinical Oncology Research

San Diego, California, United States

Saint Francis Hospital And Medical Center

Hartford, Connecticut, United States

Hematology Oncology, P.C.

Stamford, Connecticut, United States

Cancer Specialists Of North Florida Beaches

Jacksonville, Florida, United States

Orlando Health, Inc. M.D. Anderson Cancer Center Orlando

Orlando, Florida, United States

Hematology Oncology Associates Of The Treasure Coast

Port Saint Lucie, Florida, United States

University Of Chicago

Chicago, Illinois, United States

Mid-Illinois Hematology/Oncology Associates, Ltd.

Normal, Illinois, United States

Oncology Specialists, Sc

Park Ridge, Illinois, United States

Central Indiana Cancer Centers

Fishers, Indiana, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Hutchinson Clinic, Pa

Hutchinson, Kansas, United States

Kentucky Cancer Clinic

Hazard, Kentucky, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Sinai Hospital Of Baltimore

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Ellis Fischel Cancer Center

Columbia, Missouri, United States

St Joseph Oncology Inc

Saint Joseph, Missouri, United States

University Of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Blumenthal Cancer Center

Charlotte, North Carolina, United States

Providence Portland Medical Center

Portland, Oregon, United States

St. Luke'S Hospital & Health Network

Bethlehem, Pennsylvania, United States

Lowcountry Hematology & Oncology, Pa

Mt. Pleasant, South Carolina, United States

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Vanderbilt-Ingram Cancer Ctr

Nashville, Tennessee, United States

Joe Arrington Cancer Research And Treatment Center

Lubbock, Texas, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Local Institution

Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Santa Fe, Santa Fe Province, Argentina

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Coffs Harbour, New South Wales, Australia

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Newcastle, New South Wales, Australia

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Port Macquarie, New South Wales, Australia

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South Brisbane, Queensland, Australia

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Box Hill, Victoria, Australia

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Vienna, , Austria

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Brasschaat, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Fortaleza, Ceará, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rs, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Santiago, , Chile

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Olomouc, , Czechia

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Prague, , Czechia

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Nantes, Cedex 1, France

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Saint-Etienne, Cedex 2, France

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Brest, Cedex, France

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Bordeaux, , France

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Marseille, , France

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Paris, , France

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Pierre-Bénite, , France

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Villejuif, , France

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Berlin, , Germany

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Heidelberg, , Germany

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Jena, , Germany

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Kiel, , Germany

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Mannheim, , Germany

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München, , Germany

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Tübingen, , Germany

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Kaposyar, , Hungary

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Dublin, Dublin 4, Ireland

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Galway, Galway, Ireland

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Cork, , Ireland

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Jerusalem, , Israel

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Tel Aviv, , Israel

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Genova, , Italy

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Milan, , Italy

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Napoli, , Italy

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Padua, , Italy

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Ragusa, , Italy

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Rome, , Italy

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Siena, , Italy

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Eindhoven, , Netherlands

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Hv Amsterdam, , Netherlands

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Wurzburg, , Netherlands

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Montebello, Oslo County, Norway

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Gdansk, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Wroclaw, , Poland

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Lisbon, , Portugal

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Pyatigorsk, Stavropol Kray, Russia

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Moscow, , Russia

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Moscow, , Russia

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Murmansk, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Stavropol, , Russia

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Port Elizabeth, Eastern Cape, South Africa

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Groenkloof, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Saxonworld, Gauteng, South Africa

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Cape Town, Western Cape, South Africa

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Johannesburg, , South Africa

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Barcelona, , Spain

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Canarias, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Basel, , Switzerland

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Geneva, , Switzerland

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Cherkassy, , Ukraine

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Dnipro, , Ukraine

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Lviv, , Ukraine

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Uzhhorod, , Ukraine

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Bristol, Avon, United Kingdom

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Poole, Dorset, United Kingdom

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Chelmsford, Essex, United Kingdom

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London, Greater London, United Kingdom

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Metropolitan Borough of Wirral, Merseyside, United Kingdom

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Guildford, Surrey, United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Chile; Czechia; France; Germany; Hungary; Ireland; Israel; Italy; Netherlands; Norway; Poland; Portugal; Russia; South Africa; Spain; Switzerland; Ukraine; United Kingdom

References

Maio M, Grob JJ, Aamdal S, Bondarenko I, Robert C, Thomas L, Garbe C, Chiarion-Sileni V, Testori A, Chen TT, Tschaika M, Wolchok JD. Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial. J Clin Oncol. 2015 Apr 1;33(10):1191-6. doi: 10.1200/JCO.2014.56.6018. Epub 2015 Feb 23.

Reference Type: DERIVED

PMID: 25713437 (View on PubMed)

Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

Reference Type: DERIVED

PMID: 25667295 (View on PubMed)

Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. doi: 10.1056/NEJMoa1104621. Epub 2011 Jun 5.

Reference Type: DERIVED

PMID: 21639810 (View on PubMed)

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CA184-024

Identifier Type: -

Identifier Source: org_study_id