| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02133742 | A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer | PHASE1 | COMPLETED | 52 | — | — | Sep 16, 2014 | Jul 3, 2019 | Jul 28, 2021 | 19 | United States |
DLT was defined as any of the following adverse events (AEs) occurring in the first two cycles of treatment which were attributable to one or both the study drugs: 1) Grade 4 neutropenia, 2) Febrile neutropenia lasting greater than (\>) 1 hour, 3) Grade greater than or equal to (\>=) 3 neutropenia with infection, 4) Grade \>=3 thrombocytopenia with bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade \>=3 non-hematologic: non-laboratory toxicities despite maximum supportive therapy or hypertension despite maximal medical therapy, 6) Grade \>=3 non-hematologic toxicities resulted in hospitalisation or medical intervention 7) Inability to complete at least 75 percent (%) of axitinib dosing or 2 infusions of pembrolizumab within the DLT observation period (up to 42 days) due to treatment related toxicity. Severity of AEs was graded according to NCI (National Cancer Institute) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
| Arm | Type | Description |
|---|---|---|
| Dose finding phase and dose expansion phase | EXPERIMENTAL | To test the maximum tolerated dose of MK-3475 at 2 mg/kg every three weeks intravenous infusion in combination with approved axitinib dose |
| Name | Type | Description |
|---|---|---|
| Axitinib | DRUG | Axitinib at starting dose of 5 mg and 3 mg BID. |
| MK-3475 | DRUG | MK-3475 with two dose levels: 2 mg/kg every three weeks to find the maximum tolerated dose and continue treatment in a dose expansion phase. |
Inclusion Criteria: * Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype with primary tumor resected * At least one measureable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. * Eastern Cooperative Oncology Group perf...