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Spots Global Cancer Trial Database for EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC

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Trial Identification

Brief Title: EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC

Official Title: Phase II Study of Radionuclide 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With MetastaticCastration Resistant Prostate Cancer (mCRPC)

Study ID: NCT05150236

Study Description

Brief Summary: This phase II study will investigate the activity and safety of radionuclide 177Lu-PSMA therapy versus 177Lu-PSMA in combination with Ipilimumab and Nivolumab in patients with metastatic castrate resistant prostate cancer (mCRPC).

Detailed Description: This is an open label, randomised, stratified, multicentre phase 2 clinical trial recruiting 110 participants over 18 months and followed for 12 months. Participants will be randomised to 177Lu-PSMA in combination with Ipilimumab and Nivolumab and 177Lu-PSMA alone in a 2:1 ratio (using minimisation with a random component) stratified by prior exposure to docetaxel.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

St Vincents Hospital, Darlinghurst, New South Wales, Australia

Calvary Mater Newcastle, Newcastle, New South Wales, Australia

Royal Brisbane and Womens hospital, Herston, Queensland, Australia

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Austin Health, Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Alfred Hospital, Melbourne, Victoria, Australia

Sir Charles Gairdner, Nedlands, Western Australia, Australia

Contact Details

Name: Shahneen Sandhu, MBBS, FRACP

Affiliation: Peter MacCallum Cancer Centre, Australia

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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