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A Single Arm Open-Label Phase II Study of Vemurafenib Followed by Ipilimumab in Subjects With Previously Untreated V600 BRAF Mutated Advanced Melanoma


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

Thank you

Trial Information

A Single Arm Open-Label Phase II Study of Vemurafenib Followed by Ipilimumab in Subjects With Previously Untreated V600 BRAF Mutated Advanced Melanoma


Inclusion Criteria:



- Previously untreated, metastatic melanoma with activating V600
Serine/threonine-protein kinase B-Raf (BRAF) mutation

- Measurable Tumor

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Exclusion Criteria:

- Autoimmune disease

- Active Brain Metastases (with symptoms or requiring corticosteroid treatment)

- Prior therapy with immunosuppressive agents (within the past 2 years) and any
anti-cancer therapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Ipilimumab treated subjects with Grade 3-4 drug related skin adverse events (AEs) during the sequence of Vemurafenib and Ipilimumab

Outcome Time Frame:

9 weeks after the last subject's first dose (LPFT) of Ipilimumab

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:

CA184-240

NCT ID:

NCT01673854

Start Date:

October 2012

Completion Date:

August 2014

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
University Hospitals of ClevelandCleveland, Ohio  44106
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Winship Cancer InstituteAtlanta, Georgia  30322
Karmanos Cancer InstituteDetroit, Michigan  48201
Baptist Cancer InstituteJacksonville, Florida  32207
New Mexico Cancer Care AllianceAlbuquerque, New Mexico  87106
Duke University HospitalDurham, North Carolina  27710
Levine Cancer InstituteCharlotte, North Carolina  28211
Beverly Hills Cancer CenterBeverly Hills, California  90211