drugset / Trial / NCT03526185
A Pilot Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes
Non-randomizedParallel-groupOpen-labelTreatment
Summary
To determine the feasibility and safety of administering a regimen of TIL/IL-2, using a cell product manufactured in the Yale Advanced Cell Therapy Laboratories, in subjects with metastatic melanoma who are not responding or have progressed after receiving prior therapy with a PD-1/PD-L1 antagonist used alone or in combination with anti-CTLA-4. Additionally, a second cohort of patients with metastatic melanoma who are not responding or have progressed after receiving prior therapy with a PD-1/PD-L1 antagonist alone or in combination with anti-CTLA-4 will receive anti-PD-1 and anti-CTLA-4 therapy with Nivolumab and Ipilimumab.
Timeline
- Start
- 2018-02-06
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | — |
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | 1e+09 cells | — |
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | 3e+11 cells | — |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |
| Background | aldesleukin | Protein / enzyme biologic | 72000 iu/kg | Intravenous |