Clinical trial · Interventional
Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Malignant Tumors
NCT02534506CI-TRIAL-00045123completedPhase 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 assess the safety and tolerability of BMS-663513 in subjects with advanced and/or metastatic malignant tumors.
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 |
|---|---|---|---|
| Malignant Tumors | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
| Urelumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Urelumab (+ Nivolumab) intravenous (IV) infusion
- interventionNames
- Drug: Urelumab
- Drug: Nivolumab
Primary outcomes (4)
- measure
- Safety of urelumab monotherapy as measured by the dose limiting toxicity (DLT) in subjects with advanced and/or metastatic malignant tumors
- timeFrame
- From day 1 of treatment up to 60 days of follow-up
- measure
- Safety of urelumab monotherapy as measured by adverse events (AEs) and serious adverse events (SAEs) in subjects with advanced and/or metastatic malignant tumors
- timeFrame
- From day 1 of treatment up to 60 days of follow-up
- measure
- Tolerability of urelumab monotherapy as measured by the DLT in subjects with advanced and/or metastatic malignant tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects with previously treated advanced malignant solid tumor * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * For certain subjects, willing and able to provide pre-treatment tumor sample Exclusion Criteria: * Known or suspected central nervous system metastases or central nervous system as the only source of disease * Other concomitant malignancies (with some exceptions per protocol) * Active, known or suspected autoimmune disease
References
Publications (0)
Data not yet available
No reference posted for this study.