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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516527
• Other study ID #: CA184-247
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2015
• Est. completion date: September 20, 2018

Study information

• Verified date: April 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 20, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Ipilimumab

Locations

Country	Name	City	State
China	Local Institution	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form