Ph I/II Ipilimumab Vemurafenib Combo - Full Text View

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:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Ipilimumab Vemurafenib

U.S. FDA Resources

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

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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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