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Site For 18-025, EA8143 A Phase 3 Study Comparing Perioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy

Site For 18-025, EA8143 A Phase 3 Study Comparing Perioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy

You are being asked to take part in this research study because you have cancer in your kidney, which is planned to be removed by a surgeon. The standard treatment for your disease is to remove the kidney or part of the kidney that contains the cancer by surgery. You are then monitored after surgery with imaging scans and exams to watch for any possible signs of recurrence (close observation)

Monika Joshi
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
 

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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03055013
SITE00000234
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Inclusion Criteria:
Newly Diagnosed higher risk RCC of any histology
No clinical or radiological evidence of distant metastases
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Age must be greater than or equal to 18 years old
ECOG Performance status must be 0 or 1
Exclusion Criteria:
Women must not be pregant or breast feeding
History of RCC that was resected with curative intent within the past 5 years
Prior or current prostate cancer is excluded
Active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
Kidney & Urinary System, Cancer
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Location Contacts
Hershey, PA ,