Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy
Sponsor: Merck Sharp & Dohme LLC + Exelixis
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Safety Lead In Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs)
Time frame: Up to approximately 21 days
Safety Lead In Phase: Number of participants who experience one or more adverse events (AEs)
Time frame: Up to approximately 74 months
Safety Lead In Phase: Number of participants who discontinue study treatment due to an AE
Time frame: Up to approximately 74 months
Efficacy Phase: Number of participants who experience one or more DLTs
Time frame: Up to approximately 21 days
Secondary Endpoints
Efficacy Phase: Duration of response (DOR)
Efficacy Phase: Progression-free survival (PFS)
Efficacy Phase: Overall survival (OS)
Eligibility Criteria
The main inclusion criteria include but are not limited to the following: * Has a histologically confirmed diagnosis of unresectable locally advanced/metastatic renal cell carcinoma (RCC) with clear cell component * Has received no other prior systemic therapy for treatment of advanced/metastatic clear cell renal cell carcinoma (ccRCC) except for adjuvant programmed cell death ligand 1 (PD-(L)1) therapy * Has disease recurrence during adjuvant anti- PD-(L)1 therapy or ≤24 months following the last dose of adjuvant anti-PD-(L)1 therapy * Is able to swallow oral medication * Submits an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated * Participants receiving bone resorptive therapy (must have therapy initiated at least 2 weeks before allocation/randomization) * Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140/90 mm Hg with no change in antihypertensive medica…
Read full criteria on CT.gov →✦ Analyst Commentary
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