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Ph I/II Ipilimumab Vemurafenib Combo

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche-Genentech
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01400451
First received: July 21, 2011
Last updated: March 14, 2013
Last verified: December 2012
History of Changes

July 21, 2011
March 14, 2013
November 2011
January 2014   (final data collection date for primary outcome measure)
  • Phase I: Safety and tolerability of combination of Ipilimumab and Vemurafenib as determined by the number and grade of Adverse Event (AEs)/Serious Adverse Events (SAEs) [ Time Frame: During dose escalation and for up to 12 weeks following the treatment of the last subject in Phase 1 ] [ Designated as safety issue: Yes ]
  • Phase II: Overall survival (time between first dose of study treatment and death; if a subject has not died, the subject will be censored at the time of last contact) [ Time Frame: At least 1 year after the last subject in Phase 2 has been enrolled (to allow estimation of the 1-year survival rate) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01400451 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ph I/II Ipilimumab Vemurafenib Combo
A Phase I/II Trial of Vemurafenib and Ipilimumab in Subjects With V600 BRAF Mutation-positive Metastatic Melanoma

Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and feasible and will show preliminary evidence of anti-tumor efficacy and survival in comparison to historical results following treatment with either agent alone.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
  • Drug: Ipilimumab (BMS-734016)
    Injection, intravenous (i.v.), cohort 1: 3 mg/kg, Escalate to cohort 2: 10 mg/kg, Escalate to cohort 3: at Recommended Phase 2 Dose (RP2D), De-escalate cohort 1A: 3 mg/kg, De-escalate cohort -1B: 10 mg/kg, (every three week) Q3wk, upto 2 yrs
    Other Names:
    • Yervoy®
    • Ipilimumab
    • BMS-734016
  • Biological: Vemurafenib
    tablets, oral, cohort 1: 960 mg Twice daily (BID) x 28 days after date, cohort 2: 960 mg BID x 28 days after date, cohort 3: at Recommended Phase 2 Dose (RP2D) x 14 days after date, De-escalate cohort 1A: 720 mg BID x 28 days after date, De-escalate cohort -1B: 720 mg BID x 28 days after date , Up to 2 yrs
Experimental: Ipilimumab + Vemurafenib
Interventions:
  • Drug: Ipilimumab (BMS-734016)
  • 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
50
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Metastatic melanoma with activating V600 BRAF mutation
  • Measurable Tumor
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

Exclusion Criteria:

  • Autoimmune disease
  • Active Brain Metastasis (must be stable after radiation for at least one month)
  • Prior therapy with immune stimulating agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT01400451
CA184-161, 2011-000906-22
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Roche-Genentech
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2012

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