RE: SCIB1 Trial on register - recruiting6 Sep 2019 15:04
Detailed 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 of advanced melanoma.
The plan for this research study is for SCIB1 to be given for up to 2 years, in combination with pembrolizumab according to the current label.
After receiving the first dose of SCIB1, the patient will then receive SCIB1 3 times, 3 weeks apart, then once 6 weeks later, and after that once every 12 weeks until the treatment is stopped.
Pembrolizumab will be given by an injection into the patient's vein once every 3 weeks. The injection, known as an infusion, usually takes about 30 minutes to complete.
Every time the patient has a SCIB1 infusion, they will also receive pembrolizumab. Additionally, there will also be some days when the patient will receive pembrolizumab alone.
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 a very short 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 4 weeks to ensure the patient is eligible to take part. For screening, the patient will need to undergo tissue typing, a melanoma tumour 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 ECG, a CT scan, skin fold thickness measurement, and medical history collection.
Over the 2-year treatment period, the patient will visit the hospital 14 times in the first 6 months and then every 3 weeks when they will continue to receive treatment. The tests that will be carried out at each visit including blood samples taken for immunological tests, which are all detailed in the study information sheets given to the patient before consent is taken. The patients will also attend for a visit 4-6 weeks after the last t
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