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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
Not Enrolling
Both
Advanced Melanoma

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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 CenterNew York, New York  10021
The Angeles Clinic & Research Inst.Los Angeles, California  90025
Blumenthal Cancer Center, Carolinas Medical CenterCharlotte, North Carolina  28204
H Lee Moffit Cancer Cnt And Res InstTampa, Florida  33612