Induction and maintenance treatment with PARP inhibitor and immunotherapy in HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC). PRIME H&N study
The PRIME H&N trial is testing a new drug combination for adults with HPV-negative head and neck cancer that has spread locally. Before having surgery to remove their tumour, participants take two medicines: dostarlimab (an immunotherapy given through a drip) and niraparib (a targeted tablet). Dostarlimab works by helping your body's immune system recognise and attack cancer cells. Niraparib blocks an enzyme that cancer cells need to fix their damaged DNA. Together, they aim to weaken or shrink the tumour before surgery. Doctors want to find out whether this treatment leaves very few living cancer cells in the tissue removed during your operation. They will also closely check how well wounds heal after surgery and monitor patients for up to two years to see if the treatment helps keep the cancer from returning.
At a glance
What is this study about?
Head and neck squamous cell carcinoma is a type of cancer that begins in the cells lining the mouth, nose, or throat. When this cancer is 'HPV-negative', it means it is not linked to the human papillomavirus. HPV-negative tumours can be harder to treat, and surgery is often a key part of the treatment plan.
In this trial, researchers are testing two drugs given before surgery, a method known as a 'window of opportunity' treatment. Dostarlimab is an immunotherapy that takes the brakes off your natural immune defences, encouraging them to attack cancer cells. Niraparib is a targeted medicine known as a PARP inhibitor, which stops cancer cells from repairing themselves. The hope is that using both drugs together will weaken or shrink the tumour before the surgeon operates.
The main goal is to see if this treatment achieves what doctors call a 'major response', meaning less than 10% of active cancer cells remain in the tissue removed during surgery. The study also checks whether having these drugs before surgery causes any problems with wound healing, and tracks patients for two years to see if the treatment helps keep the cancer away.
Key takeaways
- Tests a combination of two cancer drugs (dostarlimab and niraparib) given before surgery.
- Open to adults aged 18 and over with HPV-negative head and neck cancer.
- Aims to shrink the tumour so fewer living cancer cells remain at the time of surgery.
- Carefully checks surgical recovery and wound healing for four weeks after your operation.
- Tracks long-term health for up to two years to see if the cancer returns.
Who may be eligible?
This trial is designed for adults aged 18 and over who have been diagnosed with locally advanced head and neck squamous cell carcinoma that is HPV-negative. Locally advanced means the tumour has grown in the head and neck area, but has not spread to distant parts of the body.
To be considered, you must already be scheduled to have an operation to remove the tumour as part of your standard cancer care.
Your hospital team will also check your general health, organ function, and medical history. This is to ensure you are well enough to receive immunotherapy, take daily tablets, and safely undergo surgery shortly after starting the medicines.
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 of age or older?
- Have you been diagnosed with head and neck squamous cell carcinoma?
- Has your doctor confirmed that your cancer is HPV-negative?
- Are you scheduled to have surgery to remove your tumour?
- Are you able to attend hospital for infusions and take daily tablets at home?
What does participation involve?
If you take part, you will receive treatment for about six weeks before your planned surgery. Dostarlimab is given through a vein as a drip in hospital, and niraparib is taken at home as daily tablets. During this time, you will have regular hospital visits for blood tests, saliva tests, and an MRI scan to see how the tumour is responding.
You will then have your planned surgery to remove the tumour. The surgical team will monitor your recovery very closely for at least four weeks to ensure your wounds heal properly. After surgery, some participants may continue maintenance treatment, and your doctor will follow your progress with regular check-ups for up to two years to see how well you are doing.
Potential risks and benefits
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Common questions
What does HPV-negative mean?
It means your cancer was not caused by the human papillomavirus. HPV-negative head and neck cancers often behave differently and need different treatment plans than HPV-positive cancers.
Will taking these medicines delay my surgery?
The trial is planned carefully around your surgical timeline. The medicines are given during the weeks leading up to your planned operation so that your surgery goes ahead safely without unnecessary delays.
How are the medicines given?
Dostarlimab is given into a vein through a drip (an infusion) at the hospital. Niraparib comes as tablets that you swallow each day at home.
What are the common side effects?
Side effects can include tiredness, nausea, changes in blood counts, and potential immune system reactions. Doctors will also watch closely for any wound healing issues after your operation.
Can I leave the study if I change my mind?
Yes. Joining a clinical trial is entirely voluntary. You can choose to stop taking part at any point, and your normal cancer care will continue as planned.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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