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RecruitingLast updated:15 August 2023

ANZUP2001: This phase II study is trying to understand whether radiation therapy (177Lu-PSMA-617) is more safe and effective alone, or in combination with immunotherapy (ipilimumab and nivolumab), in people with metastatic, castration resistant prostate cancerPhase II Study of Radionuclide 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With MetastaticCastration Resistant Prostate Cancer (mCRPC)

Clinical summary Eligibilty Participating hospital Support

Clinical summary

Summary

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.

Age

People 18+

Phase

Trial Acronym

ANZUP2001

More information

Trial Identifiers

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NCT05150236
EVOLUTION ANZUP2001 NC291

Commercial Sponsor

Bristol-Myers Squibb (BMS), Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

Scientific 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)

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Eligibility

Inclusion

You have certain types of non-cancer medical conditions.
You have been diagnosed with a prior or secondary type of cancer.
You have had certain treatments, surgical procedures or drugs.

Exclusion

You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Your cancer has spread to other parts of the body.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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