Nivolumab with or without ipilumumab in people with HIV and cancer

Currently recruiting: 
Yes
The challenge: 

New anti-cancer therapies have recently been developed that are able to harness the body’s immune system in order to use it’s ability to attack established cancers. These drugs have shown major benefits in many previously incurable cancers. However, despite their potential benefits, these drugs have not yet been studied in people infected with HIV, due to concerns over toxicity and side effects in individuals with impaired immune systems. Additionally, these new anti-cancer drugs are suspected to impact on HIV persistence, with potential implications for HIV eradication and cure.

The project: 

Together with the U.S. National Cancer Institute AIDS Malignancy Consortium (AMC), the Kirby Institute will participate in a phase I/II study of two immune targeted anti-cancer drugs (called immune checkpoint inhibitors), ipilimumab and nivolumab (study title AMC-095). The aim is to assess the safety of these drugs in HIV-infected people with advanced cancers. We will also investigate their effects on the participant’s cancer and on their HIV infection. The AMC is a U.S-based clinical trial collaboration that supports innovating clinical trials for people with HIV and AIDS related cancers. The Kirby Institute, and our clinical site at St Vincent’s Hospital Sydney, is the first international institution selected as a core site for AMC sponsored clinical trials, giving Australian patients with HIV and cancer access to cancer clinical trials for the first time. 

The method: 

AMC-095 is a phase I/II study investigating the effects of nivolumab and ipilumumab in HIV-infected individuals with advanced cancers. In this study, a number of different doses of both drugs will be tested to determine the optimum dose for HIV-infected individuals. The effects of the drugs on the tumour will also be measured to determine if these drugs are effective for treating the participant’s particular type of cancer.

Additionally, the HIV viral reservoir will be measured before and after treatment, in order to determine what effect, if any, these drugs are having on the persistence of HIV In the body. 

The results: 

Accrual has commenced and results are anticipated in early 2018.

The impact: 

While people with HIV are disproportionately affected by cancer, they have historically been excluded from cancer clinical trials. This is a major barrier to progress, as they cannot access the most innovative new medicines and critical knowledge to use anti-cancer drugs safely in this population is lacking. This new collaboration with the AMC gives Australian patients with HIV and cancer access to clinical trials of innovative cancer therapies for the first time. The drugs being tested here are among the most promising new cancer drugs, and have the potential to transform treatment of many advanced cancers and potentially even assist in the eradication of HIV infection. This trial will provide fundamental information regarding their use in people with HIV and cancer.

Project contact: 
Senior Clinical Project Coordinator
Project supporters: 
Project collaborators: 

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