| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02179918 | A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036) | PHASE1 | COMPLETED | 23 | — | — | Aug 1, 2014 | Feb 1, 2017 | Feb 8, 2019 | 9 | United States |
Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) \<1000/mm3 with a single temperature of \>38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade\>=3 neutropenic infection; Grade\>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade\>=3 toxicities (non-laboratory); Grade\>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade\>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period.
| Arm | Type | Description |
|---|---|---|
| PF-05082566 +MK-3475 | EXPERIMENTAL | PF-05082566 +MK-3475 |
| Name | Type | Description |
|---|---|---|
| PF-05082566 | DRUG | Starting dose of 0.45 mg/kg q3wks IV, dose escalation |
| MK-3475 | DRUG | 2 mg/kg q3wks, IV |
Inclusion Criteria: * Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available. * Measurable disease per RECIST v1.1. * Adequate bone marrow, renal and liver functioning Exclusion Crit...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |