Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

TEMPLE - Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy

This study, called TEMPLE, is looking into treating cancer by combining two established cancer drugs, Mercaptopurine and Thioguanine, with a newer immunotherapy drug called Tecentriq. The main goal is to see if combining these treatments is safe and effective. In the first part of the study, researchers will carefully find the best dose of the new combination therapy. In the second part, they will check how well this combined treatment shrinks tumours or stops them from growing. They will also look at how long people live and how long the treatment works. This research aims to find better ways to fight cancer by using existing treatments in new ways.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Rigshospitalet

Enrolment target

Start

11 Nov 2024

Oncology

What is this study about?

This is a medical study called TEMPLE, and it's designed to explore new approaches to treating cancer. Doctors are always looking for better and safer ways to help people with cancer, and that's exactly what this study is trying to do.

The study is using a combination of medicines. Two of these, Mercaptopurine and Thioguanine, are drugs that have been used in cancer treatment for a while. The third drug is called Tecentriq, which is a type of immunotherapy. Immunotherapy works by helping your own body's immune system to fight cancer cells. The idea behind this study is to see if using these three drugs together can be more effective than using them separately.

The study has two main parts. The first part focuses on safety and finding the right dose. It's really important to make sure the treatment is safe and to figure out the best amount of medicine to give. The second part will then look at how well this combined treatment works against cancer. This includes seeing if tumours shrink or stop growing, and generally how people feel and get on with the treatment.

Key takeaways

This study is exploring a new combination of existing cancer drugs and immunotherapy.
The main goals are to find a safe dose and see how well the new combination treats cancer.
It's open to adults aged 18 and over.
Participation involves regular clinic visits, treatments, and health checks.
There are potential benefits and risks, which will be fully explained by the study team.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, people need to meet certain requirements. The study is open to both men and women.

Participants must be at least 18 years old. There isn't an upper age limit mentioned, which means older adults might also be able to take part if they meet the other health criteria.

The study is specifically for people who have certain types of cancer. The medical team will check your full health history and specific cancer type to see if you are a good fit for this research.

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.

Are you 18 years old or older?
Do you have a cancer diagnosis that fits the study criteria? (Your doctor will confirm this.)
Are you able to attend regular clinic visits and treatments?
Are you willing to potentially receive a new combination of medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medications (Mercaptopurine, Thioguanine, and Tecentriq) as directed by the study doctors. This will involve regular visits to the clinic for treatments and check-ups. During these visits, the medical team will monitor your health closely, which will likely include blood tests, scans, and other assessments to see how you are responding to the treatment and to check for any side effects. You might also be asked to provide samples, such as tumour biopsies or blood, at different points to help researchers understand how the treatment works at a more detailed level. The total duration of your participation could vary depending on your response to treatment and the study's design.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from a new treatment combination that could help your condition or you might not. The information gathered from your participation could help others with similar conditions in the future. However, there are also risks, as new treatments can have side effects that are not fully known or can be uncomfortable or serious. The study doctors will carefully explain all known side effects and what to expect. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What kind of cancer is this study for?

This study is designed for people with certain types of cancer, but the specific details will be discussed by your doctor.

What are the main medicines being tested?

The study combines two older cancer drugs, Mercaptopurine and Thioguanine, with a newer immunotherapy called Tecentriq.

What does 'immunotherapy' mean?

Immunotherapy helps your body's own immune system to recognise and fight off cancer cells more effectively.

Will I know if the treatment is working?

The study doctors will regularly check your health with tests and scans to see how you respond to the treatment.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.