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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)
Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)
Bristol-Myers Squibb (BMS)
Eligible participants will be randomised to one of two experimental arms. In Arm A, participants will receive 177Lu-PSMA (7.5GBq, every 6 weeks up to 6 cycles), in combination with Ipilimumab (3mg/kg every 6 weeks, up to 4 doses) and Nivolumab (1mg/kg every 3 weeks, up to 8 doses), followed by Nivolumab monotherapy (480mg, every 4 weeks, up to 18 doses).
In Arm B, participants will receive 177Lu-PSMA (7.5GBq) given every 6 weeks up to 6 cycles.