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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipilimumab

Drug

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
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
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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Aug 6, 2015
Registry last updated: May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed