Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | August 2006 |
| End Date: | October 2013 |
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
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
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
For the extension phase:
Allocation: single arm study; Masking: open label; Intervention Model: Single Group
Allocation: single arm study; Masking: open label; Intervention Model: Single Group
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
We found this trial at
33
sites
4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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St Luke'S Hospital And Health Network St. Luke's University Health Network (SLUHN) is a nonprofit,...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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114 Woodland St
Hartford, Connecticut 06105
Hartford, Connecticut 06105
(860) 714-4000
Saint Francis Hospital and Medical Center Saint Francis Hospital and Medical Center has come a...
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Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1400 South Orange Avenue
Orlando, Florida 32806
Orlando, Florida 32806
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