SCIB1 in Melanoma Patients Receiving Pembrolizumab SCIB1-002

Summary

Participation Requirements

Description

This is an open label, single arm Phase 2 study to determine the safety and tolerability of SCIB1 administered to patients with advanced melanoma using an electroporation device (the TDS-IM v2.0 device) when added to pembrolizumab (Keytruda), a standard treatment already approved for the treatment o...

This is an open label, single arm Phase 2 study to determine the safety and tolerability of SCIB1 administered to patients with advanced melanoma using an electroporation device (the TDS-IM v2.0 device) when added to pembrolizumab (Keytruda), a standard treatment already approved for the treatment of advanced melanoma. The plan for this study is for SCIB1 to be given for up to 25 weeks, in combination with pembrolizumab according to the current label. After receiving the first dose of SCIB1, the patient will then receive SCIB1 another 4 times at 4, 7, 13 and 25 weeks. Pembrolizumab treatment will be started 1 week after the first dose of SCIB1 and given every 6 weeks. Pembrolizumab will be given by an injection into the patient's vein. The injection, known as an infusion, usually takes about 30 minutes to complete. On each occasion, SCIB1 will be given by two injections into a muscle in a different limb, e.g. one into the upper arm and the other into the thigh. Instead of a normal needle and syringe, a small, hand-held device. TDS-IM v2.0 will be used to inject SCIB1 into the muscles. The site of SCIB1 administration will alternate on each occasion. The injection device is designed to increase the amount of SCIB1 that is delivered to the muscle cells. The liquid containing SCIB1 will be delivered through the injection needle. Immediately after the injection, the device will give an electrical impulse to the muscle through the four thin wires at the site of the injection. The impulse will last for less than one tenth of a second. A short video will be shown to the patient before the first injection is given to show the patient what will happen. Before treatment starts and after consent has been given, all patients will undergo screening tests for up to 28 days to ensure the patient is eligible to take part. For screening, the patient will need to undergo tissue typing, a melanoma tumor biopsy will be required if an adequate sample for testing was not previously performed, an eye examination, blood and urine samples taken for clinical laboratory tests, pregnancy status (for female patients only), tests of their immune functions, a physical examination including their vital signs, performance status and an electrocardiogram (ECG), a computerised tomography (CT) scan plus a visual inspection of any skin lesions, skin fold thickness measurement, and medical history collection. Over the 25-week treatment period, the patient will visit the hospital 11 times and have two telephone calls. They will then have an end of treatment (EOT) visit approximately 4 weeks after the last SCIB1 treatment and a further two to five visits after the EOT visit.. The evaluations and procedures that will be carried out at each visit are all detailed in the study information sheets given to the patient before consent is taken. At some of these visits, blood samples will be taken for immunological tests. Female participants of childbearing potential will undergo pregnancy testing at seven time points. This will be during screening, at the start of treatment, 7 weeks after the first dose of SCIB1 and then every 6 weeks until the end of the treatment period. At certain visits, all patients will have physical examinations and have their skin lesions assessed and photographed. At all visits, patients will be asked about other medications they are taking and about any adverse effects they might have experienced since their previous clinic visit. In response to the COVID-19 pandemic, the treatment burden for patients has also been reduced where possible by conducting remote assessments via telephone or video conference, and by limiting the duration of SCIB1 treatment to 6 months, though pembrolizumab treatment may still continue as standard of care at the discretion of the Study Investigator. After receiving their last dose of SCIB1, all surviving participants will be attending two to five clinic visits and having telephone calls every 12 weeks (when an onsite assessment is not scheduled) for up to 1 year from the first dose of SCIB1. At each assessment questions will be asked about the following: development of infection, immunological reactions, participation in any other clinical trials and subsequent exposure to highly potent treatments.

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