Ph I 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: January 23, 2014
Last verified: January 2014
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I 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 ]

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Primary Completion Date: April 2013 (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

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

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

Locations
United States, California
University Of California Los Angeles
Los Angeles, California, United States, 90095
United States, Massachusetts
Dana Farber Cancer Inst
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Bristol-Myers Squibb
Roche-Genentech
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: January 23, 2014
Health Authority: United States: Food and Drug Administration

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