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

Phase 1

Completed

• Conditions: Melanoma
• Interventions: Drug: Ipilimumab

• Registration Number: NCT02516527
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-06
• Study Start: 2015-10-16
• Primary Completion: 2018-09-20
• Study Completion: 2018-09-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maintenance Phase:Ipilimumab	Ipilimumab	Ipilimumab dose as specified
Induction Phase:Ipilimumab	Ipilimumab	Ipilimumab dose as specified

Primary Outcome Measures

Name	Time	Method
The safety of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths	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	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	Up to 90 days post discontinuation of dosing

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Guangzhou, Guangdong, China