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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

April 29, 2022

Primary Completion Date

August 31, 2024

Study Completion Date

December 31, 2024

Conditions
Prostatic NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsProstate CancerNeoplasms by SiteNeoplasmsProstatic Disease
Interventions
DRUG

177Lu-PSMA-617

Patients will be given 7.5GBq of Lu-PSMA every 6 weeks up to 6 cycles unless there is unacceptable toxicity, commencing following result of 68Ga-PSMA PET within 28 days of registration.

DRUG

Ipilimumab

Patients will be given 3mg/kg of Ipilimumab every 6 weeks up to 4 doses unless there is unacceptable toxicity, concurrently with Lu-PSMA and Nivolumab.

DRUG

Nivolumab

Patients will be given 1mg/kg of Nivolumab every 3 weeks up to 8 doses, concurrently with Lu-PSMA and Ipilimumab unless there is unacceptable toxicity. Followed by 480mg nivolumab monotherapy commencing at week 32. Nivolumab monotherapy will be given to patients every 4 weeks up to 18 doses, or until disease progression or unacceptable toxicity.

Trial Locations (8)

2010

St Vincents Hospital, Darlinghurst

2298

Calvary Mater Newcastle, Newcastle

3000

Peter MacCallum Cancer Centre, Melbourne

3004

Alfred Hospital, Melbourne

3084

Austin Health, Heidelberg

4029

Royal Brisbane and Womens hospital, Herston

5000

Royal Adelaide Hospital, Adelaide

6009

Sir Charles Gairdner, Nedlands

All Listed Sponsors
collaborator

Prostate Cancer Foundation of Australia

UNKNOWN

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Advanced Accelerator Applications

INDUSTRY

collaborator

University of Sydney

OTHER

lead

Australian and New Zealand Urogenital and Prostate Cancer Trials Group

OTHER