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Ph I/II Ipilimumab Vemurafenib Combo
This study is currently recruiting participants.
Verified November 2011 by Bristol-Myers Squibb

First Received on July 21, 2011.   Last Updated on April 30, 2012   History of Changes
Sponsor: Bristol-Myers Squibb
Collaborator: Roche-Genentech
Information provided by (Responsible Party): Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01400451
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: Ipilimumab (BMS-734016)
Biological: Vemurafenib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Vemurafenib and Ipilimumab in Subjects With V600 BRAF Mutation-positive Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab + Vemurafenib 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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400451

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
University Of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Antoni Ribas, Site 004            
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: F. Stephen Hodi, Site 001     617-632-5053        
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: F. Stephen Hodi, Site 005     617-632-5053        
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: F. Stephen Hodi, Site 006     617-632-5053        
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jedd D. Wolchok, Site 002     646-888-2395        
Australia, Victoria
Local Institution Not yet recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Site 008            
France
Local Institution Not yet recruiting
Villejuif Cedex, France, 94800
Contact: Site 007            
Sponsors and Collaborators
Bristol-Myers Squibb
Roche-Genentech
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01400451     History of Changes
Other Study ID Numbers: CA184-161, 2011-000906-22
Study First Received: July 21, 2011
Last Updated: April 30, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Afssaps - French Health Products Safety Agency

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 23, 2012