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CompletedNCT02516527Updated May 1, 2020

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

A Phase 1 interventional study of Ipilimumab in Melanoma, sponsored by Bristol-Myers Squibb. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-01.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Sep 2018, 8 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Melanoma

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03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.

This study's enrollment of 25 is below the median of 38 across 2,350 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion criteria

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

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

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Induction Phase:Ipilimumab

    Ipilimumab dose as specified

    Drug: Ipilimumab

  • Experimental
    Maintenance Phase:Ipilimumab

    Ipilimumab dose as specified

    Drug: Ipilimumab

Interventions

  • DrugIpilimumab
06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
  • Local Institution
    Guangzhou, Guangdong 510060, China
08

References and documents

Publications

  • Ma Y, Fang W, Zhao H, Bathena SP, Tendolkar A, Sheng J, Zhang L. A Phase I Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Patients with Select Advanced Solid Tumors. Oncologist. 2021 Apr;26(4):e549-e566. doi: 10.1002/onco.13577. Epub 2020 Nov 11. PubMed 33105036 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02516527
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Aug 6, 2015
Start date
Oct 16, 2015
Primary completion
Sep 20, 2018
Completion
Sep 20, 2018
Last update
May 1, 2020

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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