Melanoma
Conditions
Brief summary
The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable
Interventions
DRUGAntiCD137
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
DRUGIpilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed malignant melanoma * Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens * Willing to undergo up to 3 biopsies of an accessible lesion
Exclusion criteria
* Active/symptomatic brain metastases * Primary ocular melanoma or primary tumor of unknown origin * Concurrent autoimmune disease * Previous treatment with a CD137 agonist or CTLA-4 inhibitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests | During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received |
Secondary
| Measure | Time frame |
|---|---|
| Evidence of clinical improvement in tumor burden confirmed by CT or MRI | Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter |
Countries
United States
Outcome results
None listed