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A Phase I/II Trial of Vemurafenib and Ipilimumab in Subjects With V600 BRAF Mutation-positive Metastatic Melanoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

A Phase I/II Trial of Vemurafenib and Ipilimumab in Subjects With V600 BRAF Mutation-positive Metastatic Melanoma


Inclusion Criteria:



- Metastatic melanoma with activating V600 BRAF mutation

- Measurable Tumor

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

Exclusion Criteria:

- Autoimmune disease

- Active Brain Metastasis (must be stable after radiation for at least one month)

- Prior therapy with immune stimulating agents

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Safety and tolerability of combination of Ipilimumab and Vemurafenib as determined by the number and grade of Adverse Event (AEs)/Serious Adverse Events (SAEs)

Outcome Time Frame:

During dose escalation and for up to 12 weeks following the treatment of the last subject in Phase 1

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-161

NCT ID:

NCT01400451

Start Date:

November 2011

Completion Date:

January 2014

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of California Los AngelesLos Angeles, California  90095-6951
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Dana-Farber Cancer InstBoston, Massachusetts  02115
Dana Farber Cancer InstBoston, Massachusetts  02215