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EVOLUTION – Phase II Study of Radionuclide 177Lu-PSMA Therapy versus 177Lu-PSMA in Combination with Ipilimumab and Nivolumab for Men with Metastatic Castration Resistant Prostate Cancer (mCRPC)
Open label, randomised, stratified, 2-arm, multicentre phase 2 clinical trial to determine the activity and safety of ipilimumab and nivolumab in combination with 177Lu-PSMA in patients with mCRPC; and to identify potential prognostic and predictive biomarkers from imaging, blood, and tissue. Clinical assessments every 3-4 weeks until radiological progression.
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Trial Summary: |
To determine the activity and safety of ipilimumab and nivolumab in combination with 177Lu-PSMA in patients with metastatic castration resistant prostate cancer (mCRPC). |
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Supported By: |
Prostate Cancer Foundation Australia (PCFA), Australian Nuclear Science and Technology Organisation (ANSTO), Bristol-Myer Squibb, AAA Novartis, Endocyte, Australasian Radiopharmaceutical Trials network (ARTnet), |
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Eligibility: |
Men with metastatic prostate cancer progressing on androgen deprivation therapy and second-generation androgen receptor targeted agent and with PSMA avid disease (surgical or medical castration, and previous chemotherapy with docetaxel). |
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Registration ID: |
NCT05150236 |
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Participation: |
Australia |
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Australian Lead Group: |
ANZUP |
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Status: |
Recruiting |
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Activation Date: |
25th March 2022 |
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Chairs: |
A/Prof Shahneen Sandhu |
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Contact: |