MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
Public ClinicalTrials.gov record NCT00094653. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.
Study identification
- NCT ID
- NCT00094653
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,783 participants
Conditions and interventions
Conditions
Interventions
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2004 (Type not available)
- Primary completion
- Aug 2009 (Actual)
- Completion
- Oct 2009 (Actual)
- Last update posted
- Jul 11, 2011
2004 – 2009
United States locations
- U.S. sites
- 110
- U.S. states
- 27
- U.S. cities
- 81
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| University Medical Center | Tucson | Arizona | 85724 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| San Diego Cancer Center | Encinitas | California | 92024 | — |
| La Jolla Hematology and Oncology Medical Group | La Jolla | California | 92037 | — |
| Scripps Cancer Center | La Jolla | California | 92037 | — |
| Moores UCSD Cancer Center | La Jolla | California | 92093 | — |
| Pacific Shores Medical Group | Long Beach | California | 90813 | — |
| Cancer Institute Medical Group, Inc | Los Angeles | California | 90025 | — |
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | — |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| North County Oncology Medical Clinical, Inc. | Oceanside | California | 92056 | — |
| City of Hope Medical Group | Pasadena | California | 91105 | — |
| University of California, San Diego | San Diego | California | 92103 | — |
| St. Mary's Medical Center - Northern California Melanoma Center | San Francisco | California | 94109 | — |
| Cancer Institute Medical Group, Inc | Santa Monica | California | 90404 | — |
| San Diego Cancer Center | Vista | California | 92081 | — |
| Anschutz Cancer Pavilion | Aurora | Colorado | 80010 | — |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | — |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | — |
| Rocky Mountain Cancer Centers | Boulder | Colorado | 80304 | — |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80909 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| University of Colorado Hospital | Denver | Colorado | 80262 | — |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | — |
| Rocky Mountain Cancer Centers | Littleton | Colorado | 80120 | — |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | 80124 | — |
| Rocky Mountain Cancer Centers | Longmont | Colorado | 80501 | — |
| Yale University School of Medicine - Oncology Outpatient Clinic | New Haven | Connecticut | 06520 | — |
| Mount Sinai Comprehensive Cancer Center at Aventura | Aventura | Florida | 33180 | — |
| Memorial Regional Cancer Center | Hollywood | Florida | 33021 | — |
| Shands Jacksonville | Jacksonville | Florida | 32209 | — |
| University of Florida/Jacksonville Faculty Clinic | Jacksonville | Florida | 32209 | — |
| Jackson Memorial Hospital & Clinics | Miami | Florida | 33136 | — |
| University of Miami Hospital & Clinics | Miami | Florida | 33136 | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| M.D. Anderson Cancer Center Orlando | Orlando | Florida | 32806 | — |
| Palm Beach Cancer Institute | Palm Beach Gardens | Florida | 33410 | — |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | — |
| Palm Beach Cancer Institute | Wellington | Florida | 33414 | — |
| Palm Beach Cancer Institute | West Palm Beach | Florida | 33401 | — |
| Emory University Hospital-Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Cancer Care Specialists of Central IL | Decatur | Illinois | 62526 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Cancer Care Specialists of Central IL | Effingham | Illinois | 62401 | — |
| Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr. | Maywood | Illinois | 60153 | — |
| Center for Cancer Care at Goshen Health System | Goshen | Indiana | 46526 | — |
| Indiana Oncology Hematology Consultants North | Indianapolis | Indiana | 46202 | — |
| American Health Network of IN, LLC | Indianapolis | Indiana | 46237 | — |
| Indiana Oncology Hematology South | Indianapolis | Indiana | 46237 | — |
| Indiana Oncology Hematology Consutants of Noblesville | Noblesville | Indiana | 46060 | — |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | — |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| Norton Hospital | Louisville | Kentucky | 40202 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | — |
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Lutherville | Maryland | 21093 | — |
| Beth Isreal Dec Medical Center | Boston | Massachusetts | 02115 | — |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Henry Ford Medical Center | Dearborn | Michigan | 48126 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Henry Ford Medical Center- West Bloomfield | West Bloomfield | Michigan | 48322 | — |
| Humphrey Cancer Center | Coon Rapids | Minnesota | 55433 | — |
| Humphrey Cancer Center | Fridley | Minnesota | 55432 | — |
| Hubert H Humphrey Cancer Center | Robbinsdale | Minnesota | 55422 | — |
| Family Cancer Center | Olive Branch | Mississippi | 38654 | — |
| Ellis Fischel Cancer Center | Columbia | Missouri | 65203 | — |
| St. Joseph Oncology, Inc | Saint Joseph | Missouri | 64507 | — |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Washington Unv. School of Med./ Siteman Cancer Center | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| The Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Hematology-Oncology Associates of Northern NJ, PA | Morristown | New Jersey | 07962 | — |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | — |
| The Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Overlook Oncology Center | Summit | New Jersey | 07901 | — |
| New Mexico Oncology Hematology Consultants, Ltd. | Albuquerque | New Mexico | 87109 | — |
| Hematology-Oncology Associates of CNY | East Syracuse | New York | 13057 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | — |
| Columbia University Medical Center, Irving Center for Clinical Research | New York | New York | 10032 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7050 | — |
| The Christ Hospital Cancer Center | Cincinnati | Ohio | 45219 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| The Oregon Clinical | Portland | Oregon | 97213 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University Hosptital | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Hillman Cancer Research Pavilion | Pittsburgh | Pennsylvania | 15213 | — |
| Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | — |
| Cancer Centers of the Carolinas | Easley | South Carolina | 29640 | — |
| Cancer Centers of the Carolinas | Greenville | South Carolina | 29615 | — |
| Cancer Centers of the Carolinas | Seneca | South Carolina | 29672 | — |
| Cancer Centers of the Carolinas | Spartanburg | South Carolina | 29307 | — |
| Family Cancer Center | Bartlett | Tennessee | 38133 | — |
| Family Cancer Center | Collierville | Tennessee | 38017 | — |
| Family Cancer Center | Memphis | Tennessee | 38119 | — |
| The West Clinic | Memphis | Tennessee | 38120 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Arlington Cancer Center | Arlington | Texas | 76012 | — |
| Center for Oncology Research and Treatment | Dallas | Texas | 75230 | — |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | — |
| Center for Oncology Research and Treatment | Richardson | Texas | 75080 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112-5550 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Fletcher Allen Health Care | Burlington | Vermont | 05405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 99 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00094653, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 11, 2011 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00094653 live on ClinicalTrials.gov.