A Randomized, Parallel, 3-arm Study to Characterize the Effect of Ipilimumab + Chemotherapy in Patients With Untreated Advanced Melanoma
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Advanced Melanoma
Both
Advanced Melanoma
Trial Information
A Randomized, Parallel, 3-arm Study to Characterize the Effect of Ipilimumab + Chemotherapy in Patients With Untreated Advanced Melanoma
Inclusion Criteria:
- Histologic diagnosis of advanced malignant melanoma
- ECOG performances status 0-1
- Measurable/evaluable disease as per mWHO criteria
Exclusion Criteria:
- Evidence of active brain metastases
- Prior treatment with anti-CTLA-4 or anti-CD137 antibody
- Total Bilirubin > 1.5 x ULN and AST or ALT > 2.5 x ULN
- Prior Autoimmune disease
- Use of immunosuppressing therapies
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pharmacokinetic parameters [Cmax, Tmax, AUC, T-HALF, and Clearence] will be derived from plasma concentration versus time for Ipilimumab, Paclitaxel and Dacarbazine
Outcome Time Frame:
Within the 7 weeks (after 3rd dose)
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:
CA184-078
NCT ID:
NCT00796991
Start Date:
February 2009
Completion Date:
October 2012
Related Keywords:
- Advanced Melanoma
- Untreated Advanced Melanoma
- Melanoma
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| The Angeles Clinic & Research Inst. | Los Angeles, California 90025 |
| Blumenthal Cancer Center, Carolinas Medical Center | Charlotte, North Carolina 28204 |
| H Lee Moffit Cancer Cnt And Res Inst | Tampa, Florida 33612 |
