Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Medarex
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00324155
First received: May 8, 2006
Last updated: July 2, 2012
Last verified: July 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: Ipilimumab Drug: Placebo Drug: Dacarbazine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Overall Survival [ Time Frame: Patient Status is assessed at every visit (Weeks 1, 4, 7, 10, 12, 13, 16, 19, 20, 22, 24 in the Induction Phase, Weeks 24, 30, 36, 42, 48 and every 12 weeks thereafter in the Maintenance Phase, and every 12 weeks in the Follow-up Phase) ] [ Designated as safety issue: No ]
- Extension phase: Survival rates at 3, 4 and 5 years [ Time Frame: Patient Status is assessed at every visit (every 12 weeks in the Extended Dosing Phase and every 24 weeks in the Extended Follow-Up Phase) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: Tumor Assessments at Baseline Visit in the Screening Phase, Wks 12, 16, 20, & 24 in Induction Phase, Wks 30, 36, 42, 48, & every 12 wks thereafter in Maintenance Phase, & the first two standard- of-care scans are collected in Follow-up Phase ] [ Designated as safety issue: No ]
- Disease Control Rate [ Time Frame: Tumor Assessments at Baseline Visit in the Screening Phase, Wks 12, 16, 20, & 24 in Induction Phase, Wks 30, 36, 42, 48, & every 12 wks thereafter in Maintenance Phase, & the first two standard- of-care scans are collected in Follow-up Phase ] [ Designated as safety issue: No ]
- Best Overall Response Rate [ Time Frame: Tumor Assessments at Baseline Visit in the Screening Phase, Wks 12, 16, 20, & 24 in Induction Phase, Wks 30, 36, 42, 48, & every 12 wks thereafter in Maintenance Phase, & the first two standard- of-care scans are collected in Follow-up Phase ] [ Designated as safety issue: No ]
- Survival rate at one year, eighteen months, and two years [ Time Frame: Patient Status is assessed at every visit (Weeks 1, 4, 7, 10, 12, 13, 16, 19, 20, 22, 24 in the Induction Phase, Weeks 24, 30, 36, 42, 48 and every 12 weeks thereafter in the Maintenance Phase, and every 12 weeks in the Follow-up Phase) ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Tumor Assessments at Baseline Visit in the Screening Phase, Wks 12, 16, 20, & 24 in Induction Phase, Wks 30, 36, 42, 48, & every 12 wks thereafter in Maintenance Phase, & the first two standard- of-care scans are collected in Follow-up Phase ] [ Designated as safety issue: No ]
- Time to Response [ Time Frame: Tumor Assessments at Baseline Visit in the Screening Phase, Wks 12, 16, 20, & 24 in Induction Phase, Wks 30, 36, 42, 48, & every 12 wks thereafter in Maintenance Phase, & the first two standard- of-care scans are collected in Follow-up Phase ] [ Designated as safety issue: No ]
- Safety Profile [ Time Frame: Adverse Events are assessed at every visit (Weeks 1, 4, 7, 10, 12, 13, 16, 19, 20, 22, 24 in the Induction Phase, Weeks 24, 30, 36, 42, 48 and every 12 weeks thereafter in the Maintenance Phase, and every 12 weeks in the Follow-up Phase) ] [ Designated as safety issue: Yes ]
- Health-Related Quality of Life (QoL) [ Time Frame: QoL assessments are performed at Weeks 1, 4, 7, 12, 24, 36, 48, and at the first follow-up phase visit ] [ Designated as safety issue: No ]
- Population Pharmacokinetics (PK) [ Time Frame: PK samples are collected at Weeks 1, 7, 7 to 8, 8 to 9, and 10 ] [ Designated as safety issue: No ]
- Extension phase: Safety profile of Ipilimumab for patients in the Extension Phase [ Time Frame: Safety will be assessed every 12 weeks in the Extended Dosing Phase and every 24 weeks in the Extended Follow-Up Phase ] [ Designated as safety issue: No ]Incidence of adverse events and their severity
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A: Ipilimumab and Dacarbazine
In Extension phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Extension phase
|
Drug: Ipilimumab
Intravenous solution; intravenous; 10mg/kg; one dose every 3 wks for 10wks then one dose every 12 wks starting at Wk24, until disease progression, unacceptable toxicity or withdrawal of consent In Extension phase: Only Ipilimumab: 10mg/kg, every 12 wks will be continued until disease progression Other Names:
Drug: Dacarbazine
Intravenous solution; intravenous; 850 mg/m2; one dose every 3 wks for 22 wks, until disease progression, unacceptable toxicity or withdrawal of consent
|
| Active Comparator: Arm B: Placebo and Dacarbazine |
Drug: Placebo
Intravenous solution; intravenous; 0 mg; one dose every 3 wks for 10 wks then one dose every 12w ks starting at Wk24; until disease progression, unacceptable toxicity or withdrawal of consent
Drug: Dacarbazine
Intravenous solution; intravenous; 850 mg/m2; one dose every 3 wks for 22 wks, until disease progression, unacceptable toxicity or withdrawal of consent
|
Detailed Description:
For the extension phase:
Allocation: single arm study; Masking: open label; Intervention Model: Single Group
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324155
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| United States, California | |
| Pacific Cancer Medical Center | |
| Anaheim, California, United States, 92801 | |
| Wilshire Oncology Medical Group Inc | |
| La Verne, California, United States, 91750 | |
| The Angeles Clinic And Research Institute | |
| Los Angeles, California, United States, 90025 | |
| Comprehensive Cancer Center | |
| Palm Springs, California, United States, 92262 | |
| Sharp Clinical Oncology Research | |
| San Diego, California, United States, 92123 | |
| United States, Connecticut | |
| Saint Francis Hospital And Medical Center | |
| Hartford, Connecticut, United States, 06105 | |
| Hematology Oncology, P.C. | |
| Stamford, Connecticut, United States, 06902 | |
| United States, Florida | |
| Integrated Community Oncology Network | |
| Jacksonville, Florida, United States, 32256 | |
| Orlando Health, Inc. M.D. Anderson Cancer Center Orlando | |
| Orlando, Florida, United States, 32806 | |
| Hematology Oncology Associates Of The Treasure Coast | |
| Port St. Lucie, Florida, United States, 34952 | |
| United States, Illinois | |
| University Of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Mid-Illinois Hematology/Oncology Associates, Ltd. | |
| Normal, Illinois, United States, 61761 | |
| Oncology Specialists, Sc | |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Indiana | |
| Central Indiana Cancer Centers | |
| Fishers, Indiana, United States, 46037 | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| Hutchinson Clinic, Pa | |
| Hutchinson, Kansas, United States, 67502 | |
| United States, Kentucky | |
| Kentucky Cancer Clinic | |
| Hazard, Kentucky, United States, 41701 | |
| United States, Maryland | |
| Greater Baltimore Medical Center | |
| Baltimore, Maryland, United States, 21204 | |
| Sinai Hospital Of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center | |
| Columbia, Missouri, United States, 65203 | |
| St Joseph Oncology Inc | |
| St Joseph, Missouri, United States, 64507 | |
| United States, New Mexico | |
| University Of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Blumenthal Cancer Center | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Oregon | |
| Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| St. Luke'S Hospital & Health Network | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| United States, South Carolina | |
| Lowcountry Hematology & Oncology, Pa | |
| Mt. Pleasant, South Carolina, United States, 29464 | |
| United States, Tennessee | |
| Thompson Cancer Survival Center | |
| Knoxville, Tennessee, United States, 37916 | |
| Vanderbilt-Ingram Cancer Ctr | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Joe Arrington Cancer Research And Treatment Center | |
| Lubbock, Texas, United States, 79410 | |
| United States, Virginia | |
| Virginia Cancer Institute | |
| Richmond, Virginia, United States, 23230 | |
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| Buenos Aires, Argentina, 1185 | |
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| Buenos Aires, Argentina, C1426ANZ | |
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| Edegem, Belgium, B-2650 | |
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| Gent, Belgium, 9000 | |
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| Fortaleza, Ceara, Brazil, 60430 | |
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| Porto Alegre, Rio Grande Do Sul, Brazil, 90050 | |
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| Olomouc, Czech Republic, 775 20 | |
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| Nantes, Cedex 1, France, 44093 | |
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| Wurzburg, Netherlands, 97080 | |
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| Montebello, Oslo, Norway, 0310 | |
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| Gdansk, Poland, 80-219 | |
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| Lodz, Poland, 93-509 | |
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| Poznan, Poland, 61-866 | |
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| Wroclaw, Poland, 51-124 | |
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| Coimbra, Portugal, 3000-075 | |
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| Lisboa, Portugal, 1099-023 | |
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| Setubal, Portugal, 2910-446 | |
| Russian Federation | |
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| Pyatigorsk, Stavropol, Russian Federation, 357502 | |
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| Barnaul, Russian Federation, 656049 | |
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| Moscow, Russian Federation, 115478 | |
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| Moscow, Russian Federation, 105229 | |
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| Murmansk, Russian Federation, 183047 | |
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| Ryazan, Russian Federation, 390011 | |
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| Samara, Russian Federation, 443066 | |
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| St Petersburg, Russian Federation, 198255 | |
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| St.-Petersburg, Russian Federation, 191104 | |
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| Stavropol, Russian Federation, 355047 | |
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| Voronezh, Russian Federation, 394000 | |
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| Port Elizabeth, Eastern Cape, South Africa, 6001 | |
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| Groenkloof, Gauteng, South Africa, 0181 | |
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| Pretoria, Gauteng, South Africa, 0041 | |
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| Saxonworld, Gauteng, South Africa, 2196 | |
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| Cape Town, Western Cape, South Africa, 7570 | |
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| Johannesburg, South Africa, 2199 | |
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| Barcelona, Spain, 08007 | |
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| Barcelona, Spain, 08036 | |
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| Canarias, Spain, 38320 | |
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| Malaga, Spain, 29010 | |
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| Valencia, Spain, 46014 | |
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| Zaragoza, Spain, 50009 | |
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| Basel, Switzerland, 4031 | |
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| Geneva, Switzerland, 1211 | |
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| Cherkassy, Ukraine, 18009 | |
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| Dnepropetrovsk, Ukraine, 49044 | |
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| Lviv, Ukraine, 79031 | |
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| Uzhgorod, Ukraine, 88000 | |
| United Kingdom | |
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| Bristol, Avon, United Kingdom, BS2 8ED | |
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| Poole, Dorset, United Kingdom, BH15 2JB | |
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| Chelmsford, Essex, United Kingdom, CM1 7ET | |
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| London, Greater London, United Kingdom, SW3 6JJ | |
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| Wirral, Merseyside, United Kingdom, CH63 4JY | |
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| Guildford, Surrey, United Kingdom, GU2 7XX | |
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided by Bristol-Myers Squibb
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00324155 History of Changes |
| Other Study ID Numbers: | CA184-024 |
| Study First Received: | May 8, 2006 |
| Last Updated: | July 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Stage IIIc N3 (unresectable) Stage IV melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013