Clear cell renal cell carcinoma
Conditions
Brief summary
Safety Lead In Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs), Safety Lead In Phase: Number of participants who experience one or more adverse events (AEs), Safety Lead In Phase: Number of participants who discontinue study treatment due to an AE, Efficacy Phase: Number of participants who experience one or more DLTs, Efficacy Phase: Number of participants who experience one or more AEs, Efficacy Phase: Number of participants who discontinue study treatment due to an AE, Efficacy Phase: Objective Response (OR)
Detailed description
Efficacy Phase: Duration of response (DOR), Efficacy Phase: Progression-free survival (PFS), Efficacy Phase: Overall survival (OS), Efficacy Phase: Clinical benefit rate (CBR)
Interventions
DRUGBelzutifan
DRUGXL092
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Lead In Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs), Safety Lead In Phase: Number of participants who experience one or more adverse events (AEs), Safety Lead In Phase: Number of participants who discontinue study treatment due to an AE, Efficacy Phase: Number of participants who experience one or more DLTs, Efficacy Phase: Number of participants who experience one or more AEs, Efficacy Phase: Number of participants who discontinue study treatment due to an AE, Efficacy Phase: Objective Response (OR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Phase: Duration of response (DOR), Efficacy Phase: Progression-free survival (PFS), Efficacy Phase: Overall survival (OS), Efficacy Phase: Clinical benefit rate (CBR) | — |
Countries
France, Poland, Spain
Outcome results
None listed