Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01673854
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.

Key Dates

Start date
Sep 13, 2012
Status verified
Jun 2018
Primary completion
Jul 25, 2014
Completion
May 12, 2015

Study Design

Enrollment
70 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
    Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Skin Adverse Events (AEs) [ Time Frame: From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first ]

Locations (14)

FacilityCityStateZIPSite coordinators
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
Baptist Cancer InstituteJacksonvilleFlorida32207-
Orlando Health, IncOrlandoFlorida32806-
Winship Cancer InstituteAtlantaGeorgia30322-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Karmanos Cancer InstituteDetroitMichigan48201-
University Of New Mexico Cancer CenterAlbuquerqueNew Mexico87106-
Mount Sinai School Of MedicineNew YorkNew York10029-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke University HospitalDurhamNorth Carolina27710-
DumcDurhamNorth Carolina27710-
University HospitalsClevelandOhio44106-
University Hospitals Of ClevelandClevelandOhio44106-

Find similar trials in Beverly Hills, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Beverly Hills Cancer Center· Beverly Hills, CABaptist Cancer Institute· Jacksonville, FLOrlando Health, Inc· Orlando, FLWinship Cancer Institute· Atlanta, GADana Farber Cancer Institute· Boston, MADana-Farber Cancer Institute· Boston, MA

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