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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01673854
First received: August 24, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine whether the sequence of 6 wk vemurafenib followed by ipilimumab monotherapy has an acceptable safety profile with regards to the skin


Condition Intervention Phase
Melanoma
Drug: Ipilimumab
Biological: Vemurafenib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm Open-Label Phase II Study of Vemurafenib Followed by Ipilimumab in Subjects With Previously Untreated V600 BRAF Mutated Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of Ipilimumab treated subjects with Grade 3-4 drug related skin adverse events (AEs) during the sequence of Vemurafenib and Ipilimumab [ Time Frame: 9 weeks after the last subject's first dose (LPFT) of Ipilimumab ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of Ipilimumab treated subjects with Grade 3-4 drug-related gastrointestinal AEs during the sequence of Vemurafenib and Ipilimumab [ Time Frame: 9 weeks after the last subject's first dose (LPFT) of Ipilimumab ] [ Designated as safety issue: Yes ]
  • Proportion of Ipilimumab treated subjects with Grade 3-4 drug-related hepatobiliary AEs during the sequence of Vemurafenib and Ipilimumab [ Time Frame: 9 weeks after the last subject's first dose (LPFT) of Ipilimumab ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: October 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vemurafenib followed by Ipilimumab

Vemurafenib 960 mg tablet by mouth (oral) twice daily for 6 weeks (Vem 1 Phase) followed by Ipilimumab 10 mg/kg Intravenous (IV) injection once every 3 weeks for 4 doses, then once every 12 weeks starting at Week 24 until disease progression (PD) or unacceptable toxicity (Ipi Phase)

Vem 2 Phase: Vemurafenib re-started at time of PD or unacceptable toxicity on Ipilimumab until PD or unacceptable toxicity

Drug: Ipilimumab
Other Names:
  • Yervoy®
  • BMS-734016
Biological: Vemurafenib
Other Name: Zelboraf®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673854

Locations
United States, California
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Md Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New Mexico
University Of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Mount Sinai School Of Medicine
New York, New York, United States, 10029
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke University Hospital
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01673854     History of Changes
Other Study ID Numbers: CA184-240, 2012‐002054‐24
Study First Received: August 24, 2012
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 15, 2014