Active not recruitingPHASE1INTERVENTIONAL

Preliminary Assessment of Safety and Tolerability of Dostarlimab in Combination Antiretroviral Therapy (cART) Refractory HIV Associated Kaposi Sarcoma

This study, called a Phase 1 trial, is looking at a new treatment called dostarlimab for a rare type of cancer called Kaposi Sarcoma (KS). KS often affects people with HIV, especially if their usual HIV treatments (cART) haven't fully controlled it. Dostarlimab is a type of immunotherapy, which helps your body's own immune system fight cancer cells. Researchers want to find out if this drug is safe for people with Kaposi Sarcoma and to understand how it works against the cancer. They will also look at whether it affects the HIV virus in the body. The study will involve a small number of patients and carefully observe them to decide if it's safe enough to continue testing in more people.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Imperial College London

Enrolment target

Start

26 May 2023

Estimated completion

31 Dec 2026

Refractory HIV Associated Kaposi Sarcoma

What is this study about?

This study is a first step in testing a new medicine called dostarlimab for a specific type of cancer. This cancer is called Kaposi Sarcoma, or KS for short. KS is quite rare and often affects people living with HIV. Usually, HIV is managed with a combination of medicines called antiretroviral therapy (cART). However, for some people with HIV, their Kaposi Sarcoma doesn't get better with cART alone. This study focuses on these individuals, as there's a need for new treatments for them.

Dostarlimab works differently from traditional chemotherapy. It's a type of treatment called immunotherapy. Imagine your immune system as your body's defence force. Sometimes, cancer cells can put up a 'shield' that stops your immune system from recognising and attacking them. Dostarlimab helps to remove this shield, allowing your immune cells to see and fight the cancer more effectively. Researchers want to see if this method is safe and if it can help shrink the Kaposi Sarcoma tumours.

The main goal of this particular study is to check the safety of dostarlimab in people with HIV-related Kaposi Sarcoma who haven't responded well to standard HIV treatments. It will also give an early idea of how well it works. The study will involve a small number of patients, and doctors will closely monitor them for any side effects. They will also look at samples from the tumours before and after treatment to understand how the drug affects the cancer at a microscopic level and if it influences HIV in the body.

Key takeaways

This study is testing a new immunotherapy drug called dostarlimab for Kaposi Sarcoma in people with HIV.
It's a Phase 1 study, mainly focused on checking the drug's safety in this specific group of patients.
The treatment involves a series of infusions over several months.
Participants must have HIV-related Kaposi Sarcoma that hasn't responded to standard HIV treatments.
Close monitoring for safety and how the treatment works will be part of the study.
Your regular HIV medicines will continue throughout the study.

Who may be eligible?

To join this study, people need to meet certain requirements. Firstly, you must have an official diagnosis of Kaposi Sarcoma confirmed by a doctor, and it should be the type that hasn't responded well to your usual HIV medicines (cART). You need to have been on your cART medicines for at least three months, and they should be working well, with your HIV levels under control and a good count of immune cells.

Your general health needs to be good enough to take part. This means having healthy organ function (like your kidneys and liver) and enough healthy blood cells. You must be 18 years or older. Your cancer also needs to be measurable, so doctors can see if the treatment is working. For women, if you could get pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control during the study.

There are also specific checks for your overall well-being. For example, a measure called 'ECOG performance status' checks your ability to carry out daily activities; for this study, you need to be able to do most of your normal activities. The medical team will go through all these details with you to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a confirmed diagnosis of Kaposi Sarcoma?
Has your Kaposi Sarcoma not responded well to your usual HIV medicines?
Are you 18 years old or older?
Are you currently taking your HIV medicines and have been stable on them for at least 3 months?
Are your general health and organ functions considered good enough for a clinical study?
For women, are you willing to use effective contraception if you could become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have some careful checks, including a fresh sample taken from your tumour (a biopsy). After these initial checks, you'll receive the study drug, dostarlimab. For the first four treatments, you'll get 500 mg every three weeks. After that, you'll get 1000 mg every six weeks. These treatments will continue for up to 48 weeks (just under a year), or until your doctors decide the treatment isn't helping anymore, or if you experience side effects that are too difficult to manage, or if you decide you no longer want to participate.

The study will be done in two parts. Initially, six patients will receive the drug, and they'll be watched very closely for any side effects for three weeks after their first dose. A special committee will then review their progress and any side effects. If all looks safe, then another 14 patients might join the study. Throughout the study, you'll have regular hospital visits for your treatment, blood tests, and check-ups to monitor your health and see how the treatment is affecting your cancer. You'll also have more tests on your tumour tissue to see how the drug is working.

Potential risks and benefits

Participating in this study might offer some potential benefits. You would receive a new treatment for Kaposi Sarcoma that's not yet widely available, and it might help if your current treatments haven't been effective. Your health will also be closely monitored by a team of experts. However, there are also potential risks; as this is an early-stage trial, the safety of dostarlimab in this specific cancer isn't fully known. You might experience side effects from the drug, some of which could be serious. There's also no guarantee that the treatment will be effective for your cancer. Remember, your participation is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Chelsea & Westminster Hospital
Verified postcode
London, United Kingdom

Common questions

What is Kaposi Sarcoma?

Kaposi Sarcoma is a rare type of cancer that affects the skin, lymph nodes, and sometimes other organs, often seen in people with HIV.

What is dostarlimab?

Dostarlimab is a new type of cancer drug called immunotherapy, which helps your body's immune system fight cancer cells more effectively.

What does 'Phase 1' mean for a study?

Phase 1 means it's one of the first studies in humans, mainly to check if a new drug is safe and to find the right dose, rather than focusing on how well it works yet.

How long does treatment last in the study?

Treatment can last for up to 48 weeks (nearly a year), but it might stop sooner if it's not helping, if side effects are too severe, or if you choose to stop.

Will I still take my HIV medicines?

Yes, you must be stable on your regular HIV medicines (cART) for at least 3 months and continue taking them during the study.