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
18 Years
N/A
Both
CANCER,NOS
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 Hopkins | Baltimore, Maryland 21231-2410 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Local Institution | Springfield, Massachusetts |
| Memorial Sloan Kettering Cancer Ctr | New York, New York 10021 |
| Providence Portland Med Ctr | Portland, Oregon 97213 |
