Not recruiting

Study of Vusolimogene Oderparepvec and Nivolumab for Patients with Solid Tumors

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called RP1, also known as Vusolimogene oderparepvec, on patients with solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. The study will explore the use of RP1 both as a standalone treatment and in combination with another medication called Nivolumab, which is also known by the brand name Opdivo. Nivolumab is a type of drug that helps the immune system fight cancer by blocking a protein called PD1, which can stop the immune system from attacking cancer cells.

The purpose of this study is to determine the safety and effectiveness of RP1, both alone and when used with Nivolumab, in treating solid tumors. The study will be conducted in two phases. In the first phase, researchers will determine the best dose of RP1 and assess its safety. In the second phase, the focus will be on evaluating how well RP1 works in combination with Nivolumab, especially in patients whose cancer has not responded to previous treatments. Participants will receive RP1 through injections directly into the tumor, and Nivolumab will be given as an infusion, which is a method of delivering medication directly into the bloodstream over a period of time.

Throughout the study, participants will be monitored for any side effects and changes in their tumors. The study aims to provide valuable information on the potential benefits of using RP1 and Nivolumab together for treating solid tumors, including those that have not responded to other treatments. The trial is expected to continue until 2027, allowing researchers to gather comprehensive data on the treatment's safety and effectiveness.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The study begins with the administration of vusolimogene oderparepvec, a solution for injection, directly into the tumor. This is known as intratumoral use.
The purpose of this phase is to determine the maximum tolerated dose and to assess the safety and tolerability of the treatment.
Step 2
Combination treatment phase
In this phase, vusolimogene oderparepvec is used in combination with nivolumab, a solution for infusion. Nivolumab is administered to help the immune system attack cancer cells.
The combination aims to enhance the treatment's effectiveness and is assessed for safety and tolerability.
Step 3
Treatment administration schedule
The treatment involves regular administration of the medications. Vusolimogene oderparepvec is injected directly into the tumor, while nivolumab is given as an infusion.
The frequency and duration of these administrations are determined by the study protocol and the patient's response to the treatment.
Step 4
Monitoring and assessment
Throughout the trial, the patient's health and response to the treatment are closely monitored. This includes regular check-ups and assessments to track any side effects or changes in the tumor.
The study aims to evaluate the overall response rate and the duration of any clinical benefits observed.
Step 5
End of treatment evaluation
At the end of the treatment period, a comprehensive evaluation is conducted to assess the effectiveness and safety of the treatment.
This includes reviewing the patient's overall health, any changes in the tumor, and any side effects experienced during the trial.

Who can join the trial?

28 criteria

Must voluntarily agree to participate and sign a consent form before any study procedures begin.
Blood clotting tests must be within normal limits. If on blood-thinning medication, specific conditions apply.
Must have a performance status of 0 or 1 on the ECOG scale, which measures daily living abilities.
For Phase 1: Must have advanced or spreading solid tumors that are not in the brain, and have either not responded to standard treatments or cannot tolerate them.
For Phase 1 Expansion and Phase 2: Must provide a recent tumor sample for testing.
For Phase 1 Expansion and Phase 2: Must have measurable disease based on specific criteria.
For Phase 1 Expansion and Phase 2: Must have a life expectancy of at least 3 months.
For Melanoma cohort: Must have Stage IIIb-IV melanoma, including specific types.
For Melanoma cohort: Must need or have previously received specific therapies for melanoma.
For Anti-PD1 failed cutaneous melanoma cohort: Must have advanced melanoma that cannot be surgically removed.
For Anti-PD1 failed cutaneous melanoma cohort: Must have confirmed disease progression while on specific therapy.
Must be 18 years or older.
For Anti-PD1 failed cutaneous melanoma cohort: Must continue specific therapy until disease progression is confirmed.
For Anti-PD1 failed cutaneous melanoma cohort: Must have known BRAF mutation status, with specific treatment conditions if positive.
For Anti-PD1 failed cutaneous melanoma cohort: Must have progressed on specific therapy in an adjuvant setting.
For Anti-PD1 failed cutaneous melanoma cohort: Must have specific enzyme levels within limits, with some exceptions.
For MSI-H or dMMR cohort: Must have specific types of metastatic cancer that have progressed on prior therapy.
For NMSC cohort: Must have specific types of advanced skin cancer not treatable with surgery.
For Anti-PD1/PD-L1 failed NSCLC cohort: Must have a confirmed diagnosis of specific lung cancer types.
For Anti-PD1/PD-L1 failed NSCLC cohort: Must have failed prior treatment, including specific therapies.
For Anti-PD1/PD-L1 failed NSCLC cohort: Must have measurable disease with specific conditions.
Must have at least one measurable tumor of a certain size.
Females of childbearing potential must have a negative pregnancy test before starting the study.
Females must agree to use effective birth control during and after the study for a specified period.
Males must agree to use effective birth control and not donate sperm during and after the study for a specified period.
Must have adequate blood cell counts and hemoglobin levels.
Must have adequate liver function, with specific enzyme levels within limits.
Must have adequate kidney function, with specific creatinine levels within limits.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer that is not a solid tumor. A solid tumor is a mass of tissue that does not contain liquid areas or cysts.
Patients who have not recovered from previous treatments or surgeries.
Patients with active infections that require treatment.
Patients with significant heart problems, such as heart failure or a recent heart attack.
Patients with uncontrolled high blood pressure.
Patients with severe lung disease.
Patients with a history of severe allergic reactions to similar treatments.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend study visits.
Patients who are participating in another clinical trial.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Besancon University Hospital Center
Verified
Besançon, France
Centre Leon Berard
Verified
Lyon, France

Trial locations

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Investigated drugs

RP1
is an investigational medication being studied for its potential to treat solid tumors. It is being tested both as a single agent and in combination with another medication. The goal is to find the most effective dose and to understand how well patients tolerate it. Researchers are also looking at how safe it is and what side effects it might cause.
Nivolumab
is a medication that helps the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. In this study, it is used in combination with RP1 to see if the two medications together can more effectively treat solid tumors, especially in patients who have not responded to other treatments.

What is already known about the treatment

RP1 – RP1 is administered as an injection and is currently being studied in clinical trials for its potential use in treating solid tumors. It is in the early phases of research, specifically Phase 1 and Phase 2 trials, to determine its safety, tolerability, and optimal dosing. The main therapeutic indication for RP1 is its use in combination with nivolumab, a PD1 blockade, to treat patients with solid tumors, including those who have not responded to previous anti-PD1 treatments. At the molecular level, RP1 works by modifying the tumor environment to enhance the immune system's ability to attack cancer cells. It is classified pharmacologically as an oncolytic virus therapy, which is designed to selectively infect and kill cancer cells while sparing normal cells.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they grow, they may press on nearby organs and tissues, potentially affecting their function. Solid tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they can invade nearby tissues and spread to other areas. The progression of solid tumors depends on their type, location, and whether they are benign or malignant.