Active not recruitingPHASE1INTERVENTIONAL

Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours

This early-stage study, called a Phase 1 trial, is looking into a new treatment called RP3 for people with advanced solid cancers. Researchers want to see how safe RP3 is when given by itself and when combined with another cancer drug called Nivolumab. They also want to work out the best dose of RP3 to use in future studies. RP3 is a specially modified virus designed to attack cancer cells directly and help your body's immune system fight the cancer. This study is for people whose cancer has either not responded to standard treatments, or who can't have or don't have other standard treatments available.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Replimune, Inc.

Enrolment target

123

Start

29 Dec 2020

Estimated completion

30 Nov 2026

Advanced Solid Tumor

What is this study about?

This study is a Phase 1 clinical trial, which means it's one of the first times this new treatment, RP3, is being tested in people. The main goal is to check how safe it is and if there are any side effects, both when RP3 is used alone and when it's given with another medicine called Nivolumab. Finding the safest and most effective dose of RP3 is also a key part of this initial study, so doctors know how much to use in later research.

RP3 is a very interesting new type of cancer treatment. It's actually a modified herpes virus (the same type that causes cold sores, but changed so it can't cause illness). This special virus is designed to do two main things: directly destroy cancer cells and also encourage your body's own immune system to fight the tumour more effectively. Think of it like a tiny, targeted warrior that also rallies your body's natural defenses against the cancer.

This study is for adults who have solid tumours that are advanced. This means the cancer may have spread or is difficult to treat with standard methods. It's for people whose cancer has continued to grow despite other treatments, or for whom standard treatments aren't suitable, or simply aren't available.

Key takeaways

This is an early-stage study (Phase 1) for advanced solid cancers.
It tests a new virus-based treatment (RP3) alone and with Nivolumab.
The main goals are to check safety and find the right dose.
RP3 works by directly destroying cancer and boosting your immune system.
You need advanced cancer and may have tried other treatments already.
Participation involves regular clinic visits, blood tests, scans, and biopsies.

Who may be eligible?

To join this study, you would generally have an advanced solid cancer that has either got worse after standard treatments, or if you can't have or don't have standard treatments available. Doctors will need to be able to measure your tumour, and there must be at least one tumour that can be injected.

You also need to be well enough to take part, and generally able to perform your usual daily activities. You'll need to agree to provide samples of your tumour for testing, which might be from past biopsies or new ones taken during the study.

Some things might stop you from joining. For example, if you've had a type of virus treatment for cancer before, or have certain active infections like herpes. If you've needed long-term antiviral medicines, or have serious lung conditions or a history of certain specific immune-related side effects from previous cancer treatments, you might not be able to take part.

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.

Do I have an advanced solid cancer?
Has my cancer grown despite standard treatments, or can I not have them?
Do I have a tumour that can be measured and injected?
Am I generally well enough to go about most of my daily activities?
Have I not had a virus-based cancer treatment before?
Do I currently have any serious active infections like herpes?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive the study treatment, RP3, which will be injected directly into some of your tumours. You may also receive Nivolumab, which is given by drip into a vein. You'll have regular visits to the clinic for medical check-ups, blood tests, and scans to see how you're responding to the treatment.

The study will involve several visits over a period of time, with careful monitoring of your health and any side effects. You will also have additional tumour biopsies during the study to help researchers understand how the treatment is working. The total duration of your participation will depend on how you respond to the treatment and the study plan, but there will be ongoing follow-up after the main treatment phase.

Potential risks and benefits

Like all clinical trials, there are potential benefits and risks. The main potential benefit is that this new treatment, RP3, either alone or with Nivolumab, might shrink your tumour or slow its growth, especially if other treatments haven't worked. However, there's no guarantee this will happen. Potential risks include side effects from the study drugs, some of which could be serious, as well as risks linked to biopsies and frequent clinic visits. It is important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

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

University of Iowa
Verified postcode
Iowa City, United States
UPMC Hillman Cancer Center
Verified postcode
Pittsburgh, United States
MD Anderson Cancer Center
Verified postcode
Houston, United States
Laboratoire de Recherche Translationnelle en Immunotherapie (LRTI), Gustave Roussy
Verified postcode
Villejuif, France
University of Athens
Verified postcode
Athens, Greece
University General Hospital Attikon
Verified postcode
Athens, Greece
Vall d'Hebron Hospital Hospital Universitario Vall d´Hebron (Vall d'Hebron University Hospital)
Verified postcode
Barcelona, Spain
Hospital Clinic Barcelona
Verified postcode
Barcelona, Spain
START Madrid CIO Clara Campal, Hospital Universitario HM Sanchinarro Unidad de Ensayos Fase I Panta 3
Verified postcode
Madrid, Spain
Hospital Clinico Universitario 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

Common questions

What is RP3?

RP3 is a specially modified virus (like the one causing cold sores, but changed) designed to directly attack cancer cells and help your immune system fight the cancer.

What is Nivolumab?

Nivolumab is another cancer drug that works by boosting your immune system's ability to find and destroy cancer cells.

Why is this a 'Phase 1' study?

Phase 1 studies are the first step in testing a new treatment in people. The main goals are to find a safe dose and understand any side effects.

What are 'solid tumours'?

Solid tumours are abnormal growths of cells that form a mass, as opposed to cancers of the blood.

Will I have to have biopsies?

Yes, you'll need to provide tumour samples, either from previous biopsies or new ones taken before and during the study.