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

Bristol-Myers Squibb1 site in 1 country25 target enrollmentOctober 16, 2015

ConditionsMelanoma

InterventionsIpilimumab

DrugsIpilimumab

Overview

Phase: Phase 1
Intervention: Ipilimumab
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Enrollment: 25
Locations: 1
Primary Endpoint: The safety of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 16, 2015

End Date

September 20, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Induction Phase:Ipilimumab

Ipilimumab dose as specified

Intervention: Ipilimumab

Maintenance Phase:Ipilimumab

Ipilimumab dose as specified

Intervention: Ipilimumab

Outcomes

Primary Outcomes

The safety of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths

Time Frame: Up to 90 days post discontinuation of dosing

Identify dose limiting toxicities in Chinese subjects with select advanced (unresectable, metastatic, or recurrent) solid tumors measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation, and deaths

Time Frame: Up to 90 days post discontinuation of dosing

The tolerability of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths

Time Frame: Up to 90 days post discontinuation of dosing