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A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03A in First Line Metastatic Participants

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506838-68-00
Acronym
MK-3475-03A
Enrollment
62
Registered
2024-01-22
Start date
2020-12-10
Completion date
Unknown
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal cell carcinoma

Brief summary

afety 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 rate (ORR)

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

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGLenvatinib
DRUGBelzutifan

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
afety 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 rate (ORR)

Secondary

MeasureTime 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, Hungary, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026