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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Paul
Lorigan
+44 (0)161 446 8002
detection@liverpool.ac.uk
Dr
Silviya
Balabanova
No telephone contact available
Silviya.balabanova@liverpool.ac.uk
Skin Cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Background and study aims
We are looking for new and better ways to treat melanoma. We have developed a blood test that tells us whether cancer cells are still present or cancer is becoming active, even if a scan looks normal. The test looks for pieces of DNA that are known to have come from the cancer, which we call ‘circulating tumour DNA’, or ctDNA. If we do not find ctDNA patients will stay on the study having blood tests either until the study ends (and we have not found ctDNA in their blood) or until we find ctDNA in the blood. If we find ctDNA, patients will be allocated to either receive the standard of care, which is ongoing follow up or nivolumab, an immune-boosting drug which we know is effective at treating melanoma. A doctor will inform patients of the possible benefits and risks when taking nivolumab. We do not know whether treating early with nivolumab, on the evidence of ctDNA alone, is of benefit to patients, and this is what we need to find out.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. If previously received prior immunotherapy, chemotherapy, cancer directed vaccine therapy or BRAF/MEK targeted therapy for cancer2. Patients with active, known or suspected autoimmune disease. Patients with type 1 diabetes mellitus, rheumatoid arthritis not requiring disease modifying drugs, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger will be permitted to enrol.3. Current other malignancy or history of another malignancy within the last 3 years. Patients who have been disease-free for 3 years, (i.e. patients with second malignancies that have been definitively treated at least 3 years ago) or patients with a history of completely resected non-melanoma skin cancer are eligible4. Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the patient’s safety, obtaining informed consent, or compliance with study procedures5. Patients with a condition requiring ongoing/long-term (> 3 months) systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement steroid doses ≤10 mg daily prednisolone equivalent are permitted in the absence of active autoimmune disease6. Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity7. History of allergies or adverse drug reaction to any of the study drug components or to any monoclonal antibody8. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection9. Prisoners or patients who are involuntarily incarcerated
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Paul
Lorigan
+44 (0)161 446 8002
detection@liverpool.ac.uk
Dr
Silviya
Balabanova
No telephone contact available
Silviya.balabanova@liverpool.ac.uk
The study is sponsored by Christie Hospital NHS Foundation Trust and funded by Bristol-Myers Squibb; Cancer Research UK.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 48994
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
