Active not recruitingPHASE1INTERVENTIONAL

Study of RP2 Monotherapy and RP2 in Combination With Nivolumab in Patients With Solid Tumors

This study, called RP2-001-18, is looking at a new treatment for adults with various advanced cancers. The treatment, RP2, is a specially adapted virus that aims to destroy cancer cells and kick-start the body's immune system to fight the cancer. It will be tested on its own and in combination with another cancer drug called nivolumab. The main goals are to find the safest and most effective dose of RP2 and to see how well it works against different types of tumors, including advanced or spread forms of uveal melanoma, lung, breast, and stomach/bowel cancers, especially those that have spread to the liver. This is a Phase 1 study, meaning it's one of the first times this treatment is being tested in humans.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Replimune, Inc.

Enrolment target

Start

17 Oct 2019

Estimated completion

31 Oct 2026

Cancer

What is this study about?

This study is a Phase 1 clinical trial designed to test a new treatment called RP2 for adults who have advanced solid tumors. This means cancers that aren't blood cancers and have grown or spread. RP2 is quite unique: it's a modified version of the cold sore virus (herpes simplex virus).

Scientists have changed this virus so that it can directly target and destroy cancer cells. Importantly, it's also designed to help your body's immune system recognise and fight the cancer more effectively. The study will look at RP2 on its own and also together with another established cancer medicine called nivolumab, to see if the combination works even better. The main aims are to understand how safe the treatment is, find the best dose to use, and get an early idea of how well it reduces or controls cancer growth. This is an early-stage study, so it's one of the first times this treatment is being thoroughly investigated in people.

The study will happen in a few stages. Initially, a small group of patients will receive increasing doses of RP2 to find a safe and recommended dose. Once that dose is found, more patients will join to test RP2 alongside nivolumab, focusing on specific cancers like advanced uveal melanoma, lung cancer, breast cancer, or certain stomach and bowel cancers, especially those that have spread to the liver. There will also be a small group of patients who receive only RP2 later in the study. This careful approach helps researchers learn about the treatment step-by-step.

Key takeaways

This study tests a new treatment (RP2) for advanced solid tumors.
RP2 is a modified virus designed to destroy cancer and boost immunity.
It will be tested alone and with another cancer drug, nivolumab.
The main goals are to find safe doses and check for early signs of effectiveness.
Specific cancers like advanced melanoma, lung, breast, and stomach/bowel cancers are included.
Participation involves regular hospital visits, tests, and biopsies.

Who may be eligible?

This study is for adults aged 18 or over who have advanced solid tumors. This means your cancer has either spread, grown, or hasn't responded to standard treatments, or there aren't any other suitable standard treatments for you. You must also be generally well enough to take part in the trial, which doctors will assess.

To be considered, you'll need to provide a recent sample of your tumor tissue (a biopsy) or have a new biopsy taken during the study. You must also have at least one tumor that doctors can measure and inject directly. There are specific requirements for blood test results and heart health that your doctor will check to make sure it's safe for you to participate.

If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting treatment and agree to use effective contraception throughout the study and for several months afterwards. Men with partners who could become pregnant also need to agree to use effective contraception for a similar period.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have an advanced solid cancer that hasn't responded to standard treatments, or for which there are no standard treatments?
Are you well enough to participate in a clinical trial, as judged by your doctor?
Are you able to provide a recent or new tumour sample (biopsy)?
Are you willing to use effective contraception if you are a woman who could get pregnant, or a man with a female partner who could get pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a number of checks, including blood tests, heart checks, and a general health review. You will receive either the RP2 treatment on its own or RP2 combined with nivolumab. The treatment will be given as injections directly into your tumor for RP2, and potentially through a drip into your vein for nivolumab.

Throughout the study, you'll have regular appointments at the hospital. These visits will involve physical examinations, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. Doctors will also take further small tissue samples (biopsies) from your tumor at certain times to understand how the treatment works.

The frequency of visits and tests will vary, especially at the beginning of the study, and will be explained in detail by the study team. You'll be carefully monitored for any side effects. Your participation continues for as long as the treatment is beneficial and safe for you, followed by a period of follow-up monitoring.

Potential risks and benefits

Taking part in an early-stage clinical trial like this could offer access to a new treatment before it's widely available. It might help in controlling your cancer, but there's no guarantee the treatment will work for you. On the other hand, there's a risk of side effects from the new drug, RP2, and from nivolumab, which are carefully monitored. As RP2 is a modified virus, there will be checks to ensure it doesn't spread. It's vital to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hospital Universitario d'Hebron
Verified postcode
Barcelona, Spain
Hospital Universitario HM Sanchinarro
Verified postcode
Madrid, Spain
Hospital Clinico de Valencia
Verified postcode
Valencia, Spain
The Clatterbridge Cancer Centre NHS Foundation Trust
Verified postcode
Bebington, United Kingdom
The Royal Marsden NHS Foundation Trust
Verified postcode
London, United Kingdom
Churchill Hospital
Verified postcode
Oxford, United Kingdom

Common questions

What is RP2?

RP2 is a specially changed virus designed to attack cancer cells and help your body's immune system fight the cancer.

What is nivolumab?

Nivolumab is an established cancer drug that works by helping your immune system recognise and kill cancer cells.

Which types of cancer is this study for?

This study is for adults with various advanced solid tumors, including uveal melanoma, lung, breast, and gastrointestinal cancers that have spread, especially to the liver.

Is this treatment available to everyone?

No, this is a research study, and only people who meet specific health and cancer criteria can join.

What does a 'Phase 1' study mean?

Phase 1 means it's an early study to check the safety of a new treatment and find the right dose, rather than primarily seeing how effective it is.