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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: September 22, 2014
Last verified: April 2014

August 24, 2012
September 22, 2014
September 2012
July 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01673854 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma
A Single Arm Open-Label Phase II Study of Vemurafenib Followed by Ipilimumab in Subjects With Previously Untreated V600 BRAF Mutated Advanced Melanoma

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
  • Drug: Ipilimumab
    Other Names:
    • Yervoy®
    • BMS-734016
  • Biological: Vemurafenib
    Other Name: Zelboraf®
Experimental: Vemurafenib followed by Ipilimumab

Vem 1 Phase: Vemurafenib 960 mg tablet by mouth twice daily for 6 weeks followed by Ipilimumab 10 mg/kg intravenous injection once every 3 weeks for 4 doses, then once every 12 weeks starting at Week 24 until disease progression (PD) or unacceptable toxicity (for a maximum treatment period of 3 years from the first dose)

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

Interventions:
  • Drug: Ipilimumab
  • Biological: Vemurafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
March 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01673854
CA184-240, 2012‐002054‐24
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP