Overview

A Phase 1 Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Subjects With Select Advanced Solid Tumors

Status:
Completed
Trial end date:
2018-09-20
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether ipilimumab is effective in the treatment of select advanced (unresectable, metastatic, or recurrent) solid tumors in Chinese subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Antibodies, Monoclonal
Ipilimumab
Criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Inclusion Criteria:

- Subjects with the following advanced solid tumors; metastatic or recurrent

- Must have measurable/non-measurable lesion per Response Evaluation Criteria in Solid
Tumors (RECIST v1.1) criteria.

- Subjects have ability to comply with treatment, procedures and pharmacokinetics (PK)
sample collection and the required study follow-up

- Chinese women and men, ages 18 years or older

Exclusion Criteria:

- Subjects with brain metastases are excluded unless clinically stable for more than 4
weeks at the time of randomization as determined by the investigator

- Subjects with ocular melanoma are excluded

- Any other malignancy from which the subject has been free of disease for less than two
years, with the exception of adequately treated and cured basal or squamous cell skin
cancer, superficial bladder cancer, or carcinoma in situ of the cervix

- History of, or currently active, autoimmune diseases, including but not limited to
inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic
sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune
vasculitis, autoimmune neuropathies (eg, Guillain-Barre syndrome). Vitiligo is not
excluded

- Any current or history of immunodeficiency, splenectomy, or splenic radiation

Other protocol defined inclusion/exclusion criteria could apply