Efficacy of PErioperative PEmbrolizumab treatment in patients with resectable metastases from kidney cancer. The PE-PE study

Conditions

Oligometastatic renal cell carcinoma

Brief summary

To assess the relapsed free survival (RFS) defined as the length of time from the randomization and the appearance of radiological progression of kidney cancer in patients who received pembrolizumab compared to those who did not.

Detailed description

• To assess the distant relapsed free survival (dRFS) in patients who received pembrolizumab compared to those who did not. The dRFS was defined as the length of time from the randomization to the appearance of distant metastases outside those treated with surgery or radiotherapy, • To assess the overall survival defined as the time from the randomization to the patient’s death or last contact in patients who received pembrolizumab compared to those who did not., • To assess the overall incidence of adverse events in patients who received pembrolizumab compared to those who did not., • To assess the overall incidence local progression in patients who received pembrolizumab plus RT compared to those who received RT alone.

Related papers

No related papers found yet.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To assess the relapsed free survival (RFS) defined as the length of time from the randomization and the appearance of radiological progression of kidney cancer in patients who received pembrolizumab compared to those who did not.	—

Secondary

Measure	Time frame
• To assess the distant relapsed free survival (dRFS) in patients who received pembrolizumab compared to those who did not. The dRFS was defined as the length of time from the randomization to the appearance of distant metastases outside those treated with surgery or radiotherapy, • To assess the overall survival defined as the time from the randomization to the patient’s death or last contact in patients who received pembrolizumab compared to those who did not., • To assess the overall incidence of adverse events in patients who received pembrolizumab compared to those who did not., • To assess the overall incidence local progression in patients who received pembrolizumab plus RT compared to those who received RT alone.	—

Measure

Time frame

• To assess the distant relapsed free survival (dRFS) in patients who received pembrolizumab compared to those who did not. The dRFS was defined as the length of time from the randomization to the appearance of distant metastases outside those treated with surgery or radiotherapy, • To assess the overall survival defined as the time from the randomization to the patient’s death or last contact in patients who received pembrolizumab compared to those who did not., • To assess the overall incidence of adverse events in patients who received pembrolizumab compared to those who did not., • To assess the overall incidence local progression in patients who received pembrolizumab plus RT compared to those who received RT alone.

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Countries

Italy

Outcome results

None listed