Active not recruitingPHASE2INTERVENTIONAL

SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)

This study is investigating two new cancer vaccines, called SCIB1 and iSCIB1+, for people with advanced skin cancer (melanoma). Researchers want to find out if these vaccines can be safely given alongside standard treatments, which are nivolumab (Opdivo) with ipilimumab (Yervoy), or pembrolizumab (Keytruda). These standard treatments are already approved for advanced melanoma. The main goals are to check if the vaccines are safe and if they can increase the chances of the standard treatments working well. They also want to see if these vaccines can help the treatment effects last longer. SCIB1 has been tested before and showed some promising signs in boosting the body’s own defence system against cancer. iSCIB1+ is a similar vaccine that might help an even wider group of patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Scancell Ltd

Enrolment target

173

Start

19 Aug 2019

Estimated completion

31 Jan 2027

Malignant Melanoma Melanoma (Skin)Melanoma Stage III Melanoma Stage IV

What is this study about?

This study is called The SCOPE Study and it’s looking into new ways to treat advanced skin cancer, also known as malignant melanoma. Melanoma is a type of cancer that starts in the skin cells. The study is particularly interested in whether two experimental cancer vaccines, called SCIB1 and iSCIB1+, can be a helpful addition to treatments already used for advanced melanoma. These standard treatments are either nivolumab (brand name Opdivo) combined with ipilimumab (brand name Yervoy), or pembrolizumab (brand name Keytruda).

The main idea behind adding these new vaccines is to see if they can work together with the standard treatments. Researchers want to know two key things: first, if the vaccines are safe when given with the existing treatments, and second, if they can improve how well these treatments work. This means checking if more patients respond to the treatment, and also if those responses last for a longer time. SCIB1 has been studied before in melanoma patients and was generally safe, showing some signs of boosting the body’s immune system to fight the cancer. iSCIB1+ is a newer version that might be effective for more people.

Taking part in this study means you would receive one of the new vaccines (SCIB1 or iSCIB1+) alongside the standard melanoma treatment. The vaccines are given as injections, and the whole study involves regular hospital visits and check-ups over an 85-week period, which is just over a year and a half. All treatment plans, including how the vaccines are given and what tests you’ll have, will be clearly explained to you before you decide to join.

Key takeaways

This study is for advanced skin cancer (melanoma).
It tests new vaccines (SCIB1/iSCIB1+) with standard treatments.
The aim is to check safety and see if the vaccines improve treatment results.
You would receive regular injections and have hospital visits for about 1.5 years.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To be considered for this study, you would need to have advanced melanoma (skin cancer) that has either spread or cannot be removed by surgery. You shouldn't have received previous treatment for this advanced stage of the disease, though some earlier treatments for melanoma might be allowed if they finished long enough ago.

Your doctor will need to decide if the standard treatments used in this study (nivolumab with ipilimumab, or pembrolizumab) are suitable for you. You also need to be at least 18 years old and generally well enough to take part, as assessed by your doctor. There are specific medical tests and genetic markers that will be checked to see if you fit the study requirements, including details about your cancer's make-up and your body's immune system.

For women who could become pregnant, it's important not to be pregnant or breastfeeding during the study, and to use effective contraception. This is because the treatments could potentially harm an unborn baby. All potential participants must be able and willing to understand and sign a consent form before any study procedures begin.

Quick self-check

Do you have advanced melanoma that can't be removed with surgery?
Are you at least 18 years old?
Have you not had previous treatment for your advanced melanoma?
Is your overall health good enough for you to take part?
Do you understand and agree to the requirements for contraception if you are a woman who could become pregnant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive one of the new vaccines (SCIB1 or iSCIB1+) along with standard melanoma treatment. The vaccines are given as injections, using a special needle-free device, into your upper arm or upper leg. These injections will happen up to 11 times over an 85-week period (about a year and a half).

Before you start treatment, you'll have screening tests over about four weeks to make sure the study is right for you. During the 85 weeks of treatment, you will need to attend hospital multiple times for appointments. There will also be some phone or video calls to check in with you. Each visit will involve various assessments and procedures, and all of these will be fully explained in detail in information sheets you receive before you agree to take part. The exact schedule of visits and what happens at each one will be discussed with you.

Potential risks and benefits

Participating in a clinical trial like this means you would receive a new, experimental treatment that might help your condition, but there's no guarantee it will work better than standard care. A potential benefit is that the new vaccines might make the standard treatments more effective or help their benefits last longer. However, like all medicines, these vaccines and the standard treatments can have side effects. These risks will be fully explained by the study team, and your safety will be closely monitored throughout the study. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Velindre University NHS Trust
Cardiff, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
East and North Hertfordshire NHS Trust
Northwood, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Oxford University Hospital NHS Foundation Trust
Oxford, United Kingdom
University Hospital Plymouth NHS Trust
Plymouth, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom

+3 more sites — see the official record for the full list.

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that starts in the cells that give skin its colour. Early diagnosis and treatment are very important.

What are cancer vaccines?

Cancer vaccines are a type of treatment designed to help your body's immune system recognise and fight cancer cells. They are different from vaccines that prevent diseases like the flu.

What do 'experimental' and 'phase 2' mean?

'Experimental' means the treatment is new and still being tested. A 'Phase 2' study checks if a new treatment is safe and starts to look at how well it works on a larger group of people.

Will I know if I'm getting the new vaccine or just standard treatment?

Everyone in this study will receive one of the new vaccines (SCIB1 or iSCIB1+) in addition to their standard melanoma treatment. There is no 'placebo' arm in this study.

Can I continue with my normal life during the study?

While you will have regular hospital visits and check-ups, the aim is to allow you to continue with your daily life as much as possible, subject to how you feel and the impact of the treatments.