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Adjuvant Immunotherapy With Anti-CTLA-4 Monoclonal Antibody (Ipilimumab) Versus Placebo After Complete Resection of High Risk Stage III Melanoma: A Randomized, Double-blind Phase 3 Trial of the EORTC Melanoma Group


Phase 3
18 Years
N/A
Open (Enrolling)
Both
High Risk Stage III Melanoma

Thank you

Trial Information

Adjuvant Immunotherapy With Anti-CTLA-4 Monoclonal Antibody (Ipilimumab) Versus Placebo After Complete Resection of High Risk Stage III Melanoma: A Randomized, Double-blind Phase 3 Trial of the EORTC Melanoma Group


Inclusion Criteria:



- Age > 18 years

- Complete and adequate resection of Stage III melanoma with histologically confirmed
melanoma metastatic to lymph node

- Disease-free

- ECOG PS 0 or 1

- Randomization within 12 weeks of surgery

Exclusion Criteria:

- No prior therapy for melanoma except surgery

- No auto-immune disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To determine whether post-operative adjuvant therapy with ipilimumab improves recurrence-free survival (RFS) as compared to placebo

Outcome Time Frame:

Upon occurrence

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-029

NCT ID:

NCT00636168

Start Date:

June 2008

Completion Date:

April 2015

Related Keywords:

  • High Risk Stage III Melanoma
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Scripps ClinicLa Jolla, California  92037
Franklin Square Hospital CenterBaltimore, Maryland  21237
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Seattle Cancer Care AllianceSeattle, Washington  98109
Dana Farber Cancer InstituteBoston, Massachusetts  02115
California Pacific Medical CenterSan Francisco, California  94115
University of LouisvilleLouisville, Kentucky  40202
The Angeles Clinic & Research InstituteLos Angeles, California  90404
Oncology Specialists, S.C.Park Ridge, Illinois  60068
Yale University School Of MedicineNew Haven, Connecticut  06520
Dana-Farber Cancer InstBoston, Massachusetts  02115
Vanderbilt-Ingram Cancer CtrNashville, Tennessee  37232
Blumenthal Cancer Center, Carolinas Medical CenterCharlotte, North Carolina  28204
North. Cal. Melanoma Center-St. Mary'S Medical CenterSan Francisco, California  94117
H Lee Moffit Cancer Cnt And Res InstTampa, Florida  33612
Atlantic Melanoma CenterMorristown, New Jersey  07960
Huntsman Cancer Institute At The Univ. Of UtahSalt Lake City, Utah  84112
Dana Farber Cancer InstBoston, Massachusetts  02215
University Hospital Of ArkansasLittle Rock, Arkansas  72205
St. Luke'S Hospital & Health Network LaboratoryBethlehem, Pennsylvania  18015