Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02652455 | Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma | EARLY_PHASE1 | COMPLETED | 11 | — | — | Mar 8, 2016 | Aug 30, 2020 | Aug 19, 2025 | 1 | United States |
Safety will be determined by assessing toxicity based upon Common Terminology Criteria for Adverse Events (CTCAE) v4.
| Arm | Type | Description |
|---|---|---|
| PD-1, CD137 and Adoptive Cell Therapy | EXPERIMENTAL | Combination Therapy and Immunotherapy as described in intervention descriptions. 1. Nivolumab Treatment: The first 6 participants will not have pre-treatment with nivolumab and instead will be scheduled for the removal of their tumor sample for tumor Infiltrating lymphocytes (TIL) growth in the lab. The second 6 participants will receive treatment with nivolumab prior to removal of tumor sample for TIL growth; about 2 weeks after their tumor sample has been taken, these participants may receive additional infusions of nivolumab. 2. Surgery to remove tumor for growth of TIL followed by: TIL growth process; lymphodepleting chemotherapy with cyclophosphamide and fludarabine; TIL infusion; Interleukin-2 treatment. |
| Name | Type | Description |
|---|---|---|
| Nivolumab | DRUG | Participants entering the study after the first 6 participants only: Treatment with nivolumab prior to removal of tumor sample for TIL growth. About 2 weeks after their tumor sample has been taken, these participants may receive additional infusions of nivolumab. |
| Surgery to Remove Tumor for Growth of TIL | PROCEDURE | All participants: Tumor sample taken for growth of TILs. Growing the TILs takes about 4-8 weeks. |
| CD137 | DRUG | All participants: Anti-CD137 agonistic antibody as an agent to augment T cell proliferation in vitro. The growth of the TIL will be accelerated by the use of CD137 activating antibody in the laboratory. |
| Cyclophosphamide | DRUG | All participants: Lymphodepleting chemotherapy intravenously, beginning 3 to 6 weeks after tumor collection for TIL growth. |
| Fludarabine | DRUG | All participants: Lymphodepleting chemotherapy intravenously, beginning after first 2 days of cyclophosphamide. |
| TIL Infusion | BIOLOGICAL | After completing one week of lymphodepleting chemotherapy, all participants will be admitted back into the hospital for IV infusion of the TIL cells. |
| Interleukin-2 | DRUG | After TIL infusion, in-patient high dose IL-2 treatment. |
Inclusion Criteria: * Must have unresectable cutaneous or mucosal metastatic stage III/IV melanoma, and in the opinion of the institutional principal investigator (PI) is an acceptable candidate for adoptive cell therapy (ACT) with high dose IL-2. * Must have anticipated residual measurable disease...