Trials / Active Not Recruiting
Active Not RecruitingNCT02644369
Study of the Effects of Pembrolizumab in Patients With Advanced Solid Tumors
Investigator-initiated Phase II Study of Pembrolizumab Immunological Response Evaluation
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2 study whose main purpose is to evaluate gene changes and immune biomarkers in patients with solid tumors during treatment with pembrolizumab and in relation to response to treatment. Pembrolizumab is a monoclonal antibody that is designed to block a protein called programmed cell death 1 ligand 1 (PD-L1) which will allow the body's immune system to kill the cancer cells.
Detailed description
This study will involve treatment with pembrolizumab, tests and procedures done for safety, and the collection of archival tumor tissue, fresh tumor biopsies, and blood samples for biomarker research (including genetic testing).
Conditions
- Squamous Cell Cancer of Head and Neck
- Triple Negative Breast Cancer
- Epithelial Ovarian Cancer
- Malignant Melanoma
- Advanced Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. |
Timeline
- Start date
- 2016-03-21
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2015-12-31
- Last updated
- 2025-03-26
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02644369. Inclusion in this directory is not an endorsement.