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

April 30, 2020 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction Phase:Ipilimumab
Ipilimumab dose as specified
Drug: Ipilimumab
Experimental: Maintenance Phase:Ipilimumab
Ipilimumab dose as specified
Drug: Ipilimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Up to 90 days post discontinuation of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2015

Primary Completion (Actual)

September 20, 2018

Study Completion (Actual)

September 20, 2018

Study Registration Dates

First Submitted

July 3, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-247

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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