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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-16

Study Completion Date

2018-09-20

Brief Summary

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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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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Induction Phase:Ipilimumab

Ipilimumab dose as specified

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type DRUG

Maintenance Phase:Ipilimumab

Ipilimumab dose as specified

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type DRUG

Interventions

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Ipilimumab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No