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Completed

NCT Number: NCT01245556

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-908662

Drug

Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously

Ipilimumab

Drug

Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously

Primary outcomes

  1. Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3

    Time frame: Assessments approximately every 3 weeks throughout the duration of the trial

Secondary outcomes

  1. Efficacy as determined by estimates of objective response rates and response duration

    Time frame: Efficacy measured every 6 weeks until week 48, then every 12 weeks

  2. 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

    Time frame: PK measured during first 4 weeks on study

  3. PD will be assessed by evaluating markers of RAS/RAF pathway activity

    Time frame: PD assessed during the first 4 weeks on study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2010
Registry last updated
Jun 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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