Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma
This study is currently recruiting participants.
Verified December 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01673854
First received: August 24, 2012
Last updated: March 28, 2013
Last verified: December 2012
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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: | August 2014 |
| Estimated Primary Completion Date: | December 2013 (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:
Biological: Vemurafenib
Other Name: Zelboraf®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Locations
| United States, California | |
| Beverly Hills Cancer Center | Recruiting |
| Beverly Hills, California, United States, 90211 | |
| Contact: Steven O'Day, Site 0011 310-432-8900 | |
| United States, Florida | |
| Baptist Cancer Institute | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Troy Guthrie Jr., Site 0002 | |
| Md Anderson Cancer Center Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Gregory K Pennock, Site 0001 321-841-1859 | |
| United States, Georgia | |
| Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: David Lawson, Site 0013 404-712-7485 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Frank Stephen Hodi, Site 0014 617-632-6076 | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: F. Stephen Hodi, Site 0007 617-632-6076 | |
| United States, Michigan | |
| Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Lawrence Flaherty, Site 0010 313-576-8808 | |
| United States, New Mexico | |
| New Mexico Cancer Care Alliance | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Contact: Montaser Shaheen, Site 0008 505-272-7813 | |
| United States, New York | |
| Mount Sinai School Of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Yvonne Saenger, Site 0004 212-241-0068 | |
| United States, North Carolina | |
| Levine Cancer Institute | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Asim Amin, Site 0009 | |
| Duke University Hospital | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: April Salama, Site 0003 | |
| United States, Ohio | |
| University Hospitals Of Cleveland | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Henry Koon, Site 0006 216-844-3681 | |
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 28, 2013 |
| 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 May 19, 2013