A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with Pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head and Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC)
This research study, called a Phase II trial, is investigating a new treatment approach for people with advanced cancers. Specifically, it's for patients with non-small cell lung cancer that has spread (metastatic NSCLC), head and neck cancer that has spread (metastatic SCCHN), or bladder cancer that has spread (metastatic mUBC). The study is testing a combination of two new drugs, IO102-IO103, with an established cancer medication called Pembrolizumab (Keytruda). The main goal is to find out how effective this new combination is at shrinking tumours and to assess its safety. This type of study helps doctors understand if a new treatment is promising enough to be tested in larger groups of patients in the future.
At a glance
What is this study about?
This study is an important step in developing new treatments for certain types of cancer that have spread to other parts of the body. These include a kind of lung cancer (called non-small cell lung cancer), head and neck cancer, and bladder cancer. When cancer has spread, it's often more challenging to treat, so doctors are always looking for better options.
The research is focusing on a new combination of medicines. It involves two new experimental drugs, known as IO102-IO103, being given alongside a drug that's already used for cancer treatment, called Pembrolizumab (brand name Keytruda). Pembrolizumab works by helping your body's immune system fight cancer. Researchers want to see if adding IO102-IO103 can make Pembrolizumab even more effective.
The main aim of this study is to see how many patients experience their tumours shrinking when treated with this new combination. This is called the 'objective response rate'. Researchers will also be looking closely at how long the treatment keeps the cancer from growing (called progression-free survival), how long any anti-cancer effect lasts, and importantly, how safe the treatment is and what side effects patients might experience.
Key takeaways
- This study is for advanced lung, head & neck, or bladder cancer.
- It tests a new combination of two drugs (IO102-IO103) with an existing one (Keytruda).
- The main aim is to see if the combination shrinks tumours and is safe.
- It's a Phase II study, meaning it's an early-stage investigation.
- Participation involves regular hospital visits for treatment and check-ups.
- You have the right to leave the study at any time.
Who may be eligible?
To be considered for this study, you would generally need to be an adult, 18 years old or older. The study is open to both men and women.
Crucially, you would need to have one of three specific types of cancer that has spread to other parts of your body: non-small cell lung cancer, head and neck cancer, or bladder cancer. This study is designed for patients who haven't yet had other treatments for their advanced cancer, making it a 'first-line' treatment.
There will also be other health checks and criteria that the study doctors will go through with you to make sure the study treatment is suitable and safe for you. This might include checking your general health, organ function, and previous medical history.
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?
- Have you been diagnosed with advanced non-small cell lung cancer, head and neck cancer, or bladder cancer?
- Has your cancer spread to other parts of your body (metastatic)?
- Have you not yet started other treatments for your advanced cancer?
What does participation involve?
If you decide to take part in this study, you would receive the combination of IO102-IO103 and Pembrolizumab as an infusion (given through a drip). The full details of how often you would receive treatment, how many treatment cycles there are, and how long each visit lasts would be explained by the study team.
You would have regular visits to the hospital or clinic for these treatments and to have a number of tests. These tests would likely include blood tests, physical examinations, and scans (like CT or MRI scans) to see how the treatment is working and to monitor your health. These assessments help the doctors understand the treatment's effects and any side effects. After your treatment period, there would also be follow-up appointments to continue monitoring your health and the long-term effects of the treatment. The total duration of your participation would depend on how long you benefit from the treatment and the study's follow-up plan, which your doctor would discuss with you.
Potential risks and benefits
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Common questions
What does 'metastatic' mean?
It means the cancer has spread from where it started to other parts of your body.
What is Pembrolizumab (Keytruda)?
It's a type of immunotherapy that helps your immune system fight cancer cells.
What is a 'Phase II' study?
This type of study tests if a new treatment is safe and has a good chance of working, usually in a smaller group of people, before larger studies.
Will I know if I'm getting the new drugs or something else?
In this specific study, everyone receives the drug combination (IO102-IO103 with Pembrolizumab). There isn't a placebo group.
How long will I be in the study?
The duration varies. You would continue treatment as long as it's helping and safe, with regular follow-up afterwards. Your doctor will explain the expected timeline.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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