Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pembrolizumab, pembrolizumab
MK-3475 · 1 trial · 1 indication
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...
MK-3475 is an investigational small molecule being studied for the treatment of Renal Cell Carcinoma. It is currently in Phase 1 clinical development. The drug is being evaluated in combination with axitinib in adult patients with previously untreated advanced renal cell cancer.
MK-3475 is a monoclonal antibody, indicated by its target class of -mab (antibody). The specific molecular target is not disclosed in the available information. It is being studied in oncology for Renal Cell Carcinoma.
MK-3475 is being developed by Pfizer, Inc., which trades under the ticker PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Renal Cell Carcinoma.
MK-3475 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently ongoing.
MK-3475 has been studied in one completed clinical trial, NCT02133742. This Phase 1 study evaluated the safety, drug interaction, and tumor markers of axitinib in combination with MK-3475 in adult patients with previously untreated advanced renal cell cancer. The trial enrolled 52 participants in the United States.
Yes, MK-3475 is also known as pembrolizumab. The drug is referred to by both names in clinical research and development contexts. It is being developed by Pfizer, Inc. for the treatment of Renal Cell Carcinoma.