Clinical trial · Interventional
A Phase 1 Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Subjects With Select Advanced Solid Tumors
NCT02516527CI-TRIAL-00044931completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Induction Phase:Ipilimumab
- description
- Ipilimumab dose as specified
- interventionNames
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
- Maintenance Phase:Ipilimumab
- description
- Ipilimumab dose as specified
- interventionNames
- Drug: Ipilimumab
Primary outcomes (3)
- measure
- The safety of ipilimumab measured by the occurrence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths
- timeFrame
- Up to 90 days post discontinuation of dosing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMa 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. PMID 33105036