Who is the right candidate for Nivolumab clinical trial?
Nivolumab drug is a fully humanized, monoclonal, immunoglobulin antibody, with which clinical trials are being undertaken for the treatment of various types of cancer. Each Nivolumab clinical trial is conducted by the US National Institute of Health and is supported by the government to help find answers to cancer treatment.
Each trial targets a particular group of candidates to study the actual impact of the drug on that particular type of cancer. Thus, the eligibility criteria for each Nivolumab clinical trial may differ. However, some of the common aspects to choose the right candidate for the trial are as follows:
- The candidate should be at least 18 years of age or an adult who can decide for themselves if they want to be a part of the Nivolumab clinical trial. If trials are to be conducted for children, parental consent is compulsory.
- The candidate should have been diagnosed with the particular type of cancer for which the trial is being undertaken. This can also include cases that have been previously treated and relapsed. If recently diagnosed, they should be of intermediate-1 or -2 or high risk, according to International Prognostic Scoring System (IPSS).
- The candidate should be able to understand and voluntarily sign an IRB-approved informed consent form.
- The candidate should not have any prior history of immune checkpoint modulator therapy.
- The candidate should not have any other malignancies.
- The candidate should adhere to the specified Eastern Cooperative Oncology Group (ECOG) performance status, as required for the trial.
- In case of a female candidate, she should not be pregnant and should give the undertaking to use contraception methods during the period of the trial.
- The Nivolumab clinical trial may also require that the candidate has all other internal organs in proper working condition.
- The candidate should have a specified levels of neutrophils, platelets, hemoglobin, and serum creatinine count.
Apart from all the above, it is usually also required that the candidate should not have had any anticancer chemotherapy within four weeks before the administration of the study drug.