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A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants who are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501254-10-00
Acronym
MK-3475-587
Enrollment
1252
Registered
2022-12-14
Start date
2018-08-24
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Advanced tumors

Brief summary

Overall Survival (OS)

Detailed description

Modified Progression Free Survival (PFS) Per Evaluation Criteria Used in the Parent Trial, Modified Event Free Survival (EFS) Per Evaluation Criteria Used in the Parent Trial, Number of Participants Who Experience Serious Adverse Events (SAEs), Number of Participants Who Experience Adverse Events of Special Interest (AEOSI), Number of Participants Who Experience Clinically Significant Adverse Events (CSAE), Number of Participants Who Experience Events of Clinical Interest (ECI), Number of Participants Who Discontinue Study Treatment Due to an AE

Interventions

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

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS)

Secondary

MeasureTime frame
Modified Progression Free Survival (PFS) Per Evaluation Criteria Used in the Parent Trial, Modified Event Free Survival (EFS) Per Evaluation Criteria Used in the Parent Trial, Number of Participants Who Experience Serious Adverse Events (SAEs), Number of Participants Who Experience Adverse Events of Special Interest (AEOSI), Number of Participants Who Experience Clinically Significant Adverse Events (CSAE), Number of Participants Who Experience Events of Clinical Interest (ECI), Number of Participants Who Discontinue Study Treatment Due to an AE

Countries

Austria, Belgium, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

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