Clinical trial · Interventional
Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma
A Phase I Study of the Biologic Effects of BMS-936559 Treatment in Subjects With Unresectable Stage III or IV Melanoma
NCT01455103CI-TRIAL-00005915PD-L1withdrawnPhase 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 evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.
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 |
|---|---|---|---|
| Stage III or IV Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-936559 (Anti-PD-L1) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: BMS-936559 (1mg/kg)
- interventionNames
- Biological: BMS-936559 (Anti-PD-L1)
- type
- EXPERIMENTAL
- label
- Arm 2: BMS-936559 (3mg/kg)
- interventionNames
- Biological: BMS-936559 (Anti-PD-L1)
- type
- EXPERIMENTAL
- label
- Arm 3: BMS-936559 (10mg/kg)
- interventionNames
- Biological: BMS-936559 (Anti-PD-L1)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) status = 0 to 1 * Subjects with unresectable Stage III or IV Melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic Melanoma * Subject must have histologic or cytologic confirmation of advanced Melanoma * Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria * Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies Exclusion Criteria: * Active or progressing brain metastases * Other concomitant malignancies (with some exceptions per protocol) * Active or history of autoimmune disease * Positive test for human immunodeficiency virus (HIV) 1\&2 or known acquired immunodeficiency syndrome (AIDS) * History of any hepatitis * Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti Programmed cell death 1 (PD-1), anti Programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies
References
Publications (0)
Data not yet available
No reference posted for this study.