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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
Lucy
Walker
lucy.walker@ucl.ac.uk
Amna
Sheri
amna.sheri@nhs.net
Andrea
Rueda
andrea.gonzalez.21@ucl.ac.uk
Andrea
Rueda
andrea.gonzalez.21@ucl.ac.uk
Melanoma and other malignant neoplasms of skin
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.
Immunotherapy is a new form of cancer treatment harnessing the immune system to attack the cancer. The main side effects are autoimmune where the body's immune system targets the healthy organs instead of the cancer. As we combine immunotherapy drugs to improve outcomes the autoimmune side effects have become limiting but we cannot predict which patients are more likely to suffer such side effects, or to benefit from treatment. This study will analyse blood samples from patients receiving immunotherapy with combination drugs to see if we can find markers to make such predictions.
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:
Observational type: Clinical Laboratory Study;
You can take part if:
You may not be able to take part if:
1. Has had prior systemic anticancer therapy (including BRaf and/or MEK inhibitors) given as primary therapy for advanced or metastatic disease. 
Prior adjuvant or neoadjuvant systemic anticancer therapy is permitted as long as the last administration of the prior regimen occurred at least 6 months prior to enrollment. Prior radiotherapy for locally advanced disease is also permitted as long as the last administration of radiotherapy occurred at least 6 months prior to enrollment. 2. Is currently receiving any substance known to have or have putative immunomodulatory effects on the immune system. Prior use of such substances may be permitted if this is at least 6 months prior to enrollment. 3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. 4. Has a known history of active TB (Bacillus Tuberculosis) 5. Hypersensitivity to ipilimumab or nivolumab or any of its excipients. 6. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. 9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 10. Has known history of, or any evidence of active, non-infectious pneumonitis. 11. Has an active infection requiring systemic therapy. 12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 14. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 15. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 16. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). 17. Has received a live vaccine within 30 days of planned start of study therapy.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Andrea
Rueda
andrea.gonzalez.21@ucl.ac.uk
Andrea
Rueda
andrea.gonzalez.21@ucl.ac.uk
Prof
Lucy
Walker
lucy.walker@ucl.ac.uk
Amna
Sheri
amna.sheri@nhs.net
The study is sponsored by University College London and funded by 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.
Read full details
for Trial ID: CPMS 39807
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
