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A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (BMS-986015) Administered in Combination With Anti-PD-1 (BMS-936558) in Advanced Refractory Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
CANCER,NOS

Thank you

Trial Information

A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (BMS-986015) Administered in Combination With Anti-PD-1 (BMS-936558) in Advanced Refractory Solid Tumors


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:



- During dose escalation, subjects with advanced solid tumors (except for primary CNS
metastases) that have progressed following at least one standard regimen

- During cohort expansion, subjects with non small cell lung cancer, melanoma, renal
cell carcinoma, melanoma, colorectal, and ovarian cancer that have received at least
one and no more than 5 prior treatment regimens

- Subjects must have measurable disease

- Subject must consent to provide previously collected tumor tissue

- Women and men ≥ 18 years of age with performance status of 0 or 1

- At least 4 weeks since any previous treatment for cancer

Exclusion Criteria:

- Prior therapy with an immune cell modulating antibody except for anti-Cytotoxic T
Lymphocyte Antigen 4 (CTLA4)

- Active or chronic autoimmune diseases

- Uncontrolled or significant cardiovascular disease

- Chronic hepatitis

- Active infection

- Active Central nervous system (CNS) metastases

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability of BMS-986015 given in combination with BMS-936558 as measured by incidence of adverse events

Outcome Time Frame:

Approximately up to 27 months

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA223-001

NCT ID:

NCT01714739

Start Date:

October 2012

Completion Date:

September 2015

Related Keywords:

  • CANCER,NOS

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
University of Chicago Medical CenterChicago, Illinois  60637
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Local InstitutionSpringfield, Massachusetts  
Memorial Sloan Kettering Cancer CtrNew York, New York  10021
Providence Portland Med CtrPortland, Oregon  97213