Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma

Melanoma Clinical Trial

Official title:

A Phase 1 Study of a RAF Inhibitor (BMS-908662) Administered in Combination With Immunotherapy (Ipilimumab) in Subjects With Unresectable Stage III or Stage IV Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245556
• Other study ID #: CA206-005
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2010
• Last updated: June 11, 2013
• Start date: January 2011
• Est. completion date: November 2012

Study information

• Verified date: June 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when administered in combination with ipilimumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion:

• Male and female subjects = 18 years of age with a histologic or cytologic diagnosis of Stage III or Stage IV (unresectable) melanoma

• Enrollment to cohort expansion will be limited to only those subjects whose tumors demonstrate the B-Raf V600E mutation

• ECOG = 1

• Adequate organ & marrow function

Exclusion:

• Uncontrolled or significant cardiovascular disease

• Cohort expansion: Prior therapy with a RAF inhibitor

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• BMS-908662
Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously
• BMS-908662
Capsules, Oral, escalating doses starting at 25 mg Q 12 h daily for 3 weeks with 3 weeks interval for 4 cycles, then Q12 h daily for 3 weeks every 12 weeks, Continuously
• Ipilimumab
Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously
• Ipilimumab
Vial, IV, escalating doses starting at 3 mg/kg, Once every 6 weeks for 4 cycles, then once every 12 weeks, Continuously

Locations

Country	Name	City	State
United States	Jedd D. Wolchok, Md,Phd	New York	New York
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3		Assessments approximately every 3 weeks throughout the duration of the trial	Yes
Secondary	Efficacy as determined by estimates of objective response rates and response duration		Efficacy measured every 6 weeks until week 48, then every 12 weeks	No
Secondary	PK for BMS-908662 as determined by minimum and maximum observed concentrations, time of maximum observed concentration, area under the concentration curve for one dosing interval and the accumulation index		PK measured during first 4 weeks on study	No
Secondary	PD will be assessed by evaluating markers of RAS/RAF pathway activity		PD assessed during the first 4 weeks on study	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form