EVOLUTION

Prostate — In Follow-up

EVOLUTION

The aim of this study is to see if combining ipilimumab and nivolumab (drugs that activate the body’s own immune response to kill cancer cells), with Lu-PSMA (a type of treatment called radionuclide therapy that can be used to treat prostate cancer by bringing radioactive atoms into the cancer cells), can further improve the anti-cancer effects of Lu-PSMA. It is thought that ipilimumab and nivolumab and Lu-PSMA may work together to treat prostate cancer. Lu-PSMA can potentially kill cancer cells and break up the tumour into small pieces that may be recognised by your immune system while ipilimumab and nivolumab help activate the immune system to find and attack the cancer. This new treatment combination may lead to shrinkage or stabilisation of previously progressing tumours and therefore hopefully stop or reverse the growth of the cancer.

The EVOLUTION Trial is an investigator-initiated trial sponsored and led by ANZUP. This trial has received funding in partnership with the Prostate Cancer Foundation of Australia, Bristol Myers Squibb and Novartis. This trial is a collaboration between ANZUP, the NHMRC Clinical Trials Centre at the University of Sydney and the Australasian Radiopharmaceutical Trials Network (ARTnet) with support from MIM Software Inc. and ANSTO.

The EVOLUTION trial is now closed to recruitment and enrolled 93 people from across Australia.

If you think this trial might be right for you, please ask your doctor.

Trial Title

Phase II Study of Radionuclide 177Lu-PSMA Therapy versus 177Lu-PSMA in Combination with Ipilimumab and Nivolumab for people with Metastatic Castration Resistant Prostate Cancer

Cancer Type

Prostate

Trial Status

In Follow-up

Protocol Number

ANZUP 2001

Trial Email

evolution.study@sydney.edu.au

Co-ordinating centre

NHMRC Clinical Trials Centre

Study Chair

A/Prof Shahneen Sandhu and Professor Louise Emmett (co-chair)

Study Objective

To determine the activity and safety of ipilimumab and nivolumab in combination with 177Lu-PSMA in patients with mCRPC.

Patient Population

People with metastatic prostate cancer progressing on androgen deprivation therapy and second-generation androgen receptor targeted agent and with PSMA avid disease (SUV max >15 at a single site, and SUV max >10 at all sites >10nm).

Primary Outcome

The primary endpoint of this study is PSA PFS at 1 year. PSA PFS is defined as the interval from the date of randomisation to the date of first evidence of PSA progression or the date of last known follow-up without PSA progression PSA PFS at 1 year is defined as the proportion of participants without PSA progression at 53 weeks after randomisation.

Recruitment Target

100 participants

Acknowledgements

The EVOLUTION Trial is an investigator-initiated trial sponsored and led by ANZUP. This trial has received funding in partnership with the Prostate Cancer Foundation of Australia, Bristol Myers Squibb and Novartis. This trial is a collaboration between ANZUP, the NHMRC Clinical Trials Centre at the University of Sydney and the Australasian Radiopharmaceutical Trials Network (ARTnet) with support from MIM Software Inc. and ANSTO.