A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

Conditions

Renal cell carcinoma

Brief summary

Disease-free Survival (DFS) as Assessed by the Investigator

Detailed description

Overall Survival (OS), Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Drug Due to an AE, First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator, Visceral Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator, Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR), DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator, OS According to Participant PD-L1 Expression Status (Positive, Negative), Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score, Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score

Related papers

No related papers found yet.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGSodium Chloride Intravenous Infusion BP 0.9% w/v

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease-free Survival (DFS) as Assessed by the Investigator	—

Secondary

Measure	Time frame
Overall Survival (OS), Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Drug Due to an AE, First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator, Visceral Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator, Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR), DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator, OS According to Participant PD-L1 Expression Status (Positive, Negative), Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score, Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score	—

Measure

Time frame

Overall Survival (OS), Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Drug Due to an AE, First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator, Visceral Disease Recurrence-Specific Survival (DRSS2) as Assessed by the Investigator, Event-Free Survival (EFS) as Assessed by the Blinded Independent Central Review (BICR), DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator, OS According to Participant PD-L1 Expression Status (Positive, Negative), Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score, Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score

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Countries

Czechia, Finland, France, Germany, Ireland, Italy, Netherlands, Poland, Spain

Outcome results

None listed