Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

ANZUP2001 : 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)

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Radiotherapy<br/>TrialTypeRadiotherapy
Trial

TwoPhase Two

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Radiotherapy,Systemic therapy | Urinary systemProstate

Trial Overview Read MoreRead more

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 cancer.
 

This trial is treating patients with metastatic, castration resistant prostate cancer.

This is a systemic and radiation therapy trial.

You may be able to join this trial if:

  • 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.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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)

Cooperative Group

Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

Commercial Sponsor

Bristol-Myers Squibb (BMS)

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.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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