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Study on the Safety and Effectiveness of Vidutolimod and Cemiplimab for Adults with Advanced or Metastatic Cancer

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 combination treatment for certain types of advanced or metastatic cancer. The cancers being studied include Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma, Triple Negative Breast Cancer, and Non-Small Cell Lung Cancer. The treatment involves two medications: Vidutolimod (also known by its code name CMP-001) and Cemiplimab (also known as REGN2810). Vidutolimod is given as an injection directly into the tumor, while Cemiplimab is administered through an infusion into a vein.

The purpose of this study is to determine how well the combination of Vidutolimod and Cemiplimab works in treating these cancers. Participants in the study will receive these treatments over a period of time, and their response to the treatment will be monitored by healthcare professionals. The study will also look at the safety of the treatment and any side effects that may occur.

Throughout the study, participants will have regular check-ups and assessments to track their progress. The study aims to provide valuable information on the effectiveness and safety of using Vidutolimod and Cemiplimab together for treating advanced or metastatic cancers. This research could potentially lead to new treatment options for patients with these types of cancer.

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
Joining the study
Upon joining the study, a diagnosis of cancer must be confirmed. This includes types such as advanced or metastatic cancer, Merkel cell carcinoma, cutaneous squamous cell carcinoma, basal cell carcinoma, triple negative breast cancer, and non-small cell lung cancer.
Eligibility requires measurable disease and adequate organ function. Performance status should be between 0 and 1, as assessed by a specific scale.
Step 2
Initial treatment phase
The treatment involves two medications: vidutolimod and cemiplimab.
Cemiplimab is administered intravenously as a 350 mg solution for infusion.
Vidutolimod is administered in two ways: subcutaneously and directly into the tumor (intratumoral use).
Step 3
Treatment administration
The administration of cemiplimab and vidutolimod is conducted according to the study protocol, which specifies the dosage and frequency.
The treatment aims to evaluate the response rate, which includes complete or partial responses to the therapy.
Step 4
Monitoring and evaluation
Throughout the study, the response to treatment is monitored using specific criteria to assess tumor response.
Adverse events and any serious side effects are recorded and evaluated for severity.
Step 5
End of study
The study is estimated to conclude by March 19, 2027.
The primary goal is to determine the effectiveness of the treatment combination in achieving a confirmed response.

Who can join the trial?

7 criteria

The patient must have a confirmed diagnosis of cancer, as specified in the study guidelines.
The patient must have a disease that can be measured, according to specific criteria used in the study.
The patient must have organs that are working well enough, based on recent lab tests done within 3 weeks before starting the study treatment.
The patient must have a good level of daily functioning, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) Performance Status, with a score of 0 to 1. This scale helps doctors understand how well a patient can carry out daily activities.
Other specific requirements defined in the study guidelines must be met.
Both male and female patients can participate.
The study includes patients from vulnerable populations.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer not listed in the study.
Patients who have had a severe allergic reaction to similar treatments in the past.
Patients with an active infection that requires treatment.
Patients who are pregnant or breastfeeding.
Patients with a history of certain heart conditions.
Patients who have received another experimental treatment within a certain time frame.
Patients with a condition that affects the immune system, like HIV.
Patients with uncontrolled diabetes or high blood pressure.
Patients with a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures for any reason.

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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
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Marseille, France
Assistance Publique Hopitaux De Paris
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Paris, France
CHU Grenoble Alpes
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La Tronche, France

Trial locations

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Investigated drugs

Vidutolimod (CMP-001)
is an investigational medication used in this clinical trial. It is administered directly into the tumor (intratumoral) and is being studied for its potential to help the immune system recognize and attack cancer cells. Vidutolimod is being tested in combination with another medication to see if it can improve the treatment outcomes for patients with certain types of advanced or metastatic cancer.
Cemiplimab
is a medication given through an intravenous infusion. It is a type of immunotherapy known as a checkpoint inhibitor, which works by blocking a specific protein on immune cells. This action helps the immune system to better detect and fight cancer cells. In this trial, cemiplimab is used in combination with vidutolimod to evaluate their effectiveness together in treating advanced or metastatic cancer.

What is already known about the treatment

Vidutolimod
Vidutolimod is administered directly into the tumor through an injection, known as intratumoral administration. It is currently being studied in clinical trials for its effectiveness in treating various advanced or metastatic cancers, including Merkel cell carcinoma, cutaneous squamous cell carcinoma, basal cell carcinoma, triple-negative breast cancer, and non-small cell lung cancer. Vidutolimod works by stimulating the immune system to recognize and attack cancer cells, enhancing the body's natural defenses against tumors. It is classified as an immunotherapy agent, specifically a toll-like receptor 9 (TLR9) agonist, which helps activate immune responses at the molecular level.
Cemiplimab
Cemiplimab is given through an intravenous infusion, meaning it is administered directly into the bloodstream. It is an approved medication used in the treatment of certain types of advanced or metastatic cancers, such as cutaneous squamous cell carcinoma and non-small cell lung cancer. Cemiplimab functions by blocking a protein called PD-1 on immune cells, which helps the immune system to better detect and destroy cancer cells. It belongs to the class of drugs known as immune checkpoint inhibitors, which are designed to enhance the immune response against cancer.

Investigated diseases

Advanced or Metastatic Cancer
This term refers to cancer that has spread from its original site to other parts of the body. It often involves multiple organs and tissues, making it more challenging to manage. The progression can vary depending on the type of cancer and the organs affected. Symptoms may include pain, fatigue, and weight loss, among others. The disease can affect the body's ability to function normally as it advances.
Merkel Cell Carcinoma (MCC)
A rare and aggressive form of skin cancer that typically appears as a painless, flesh-colored or bluish-red nodule on sun-exposed skin. It tends to grow quickly and can spread to other parts of the body, including lymph nodes and internal organs. The exact cause is not fully understood, but it is often associated with a virus called Merkel cell polyomavirus. MCC is more common in older adults and those with weakened immune systems.
Cutaneous Squamous Cell Carcinoma (CSCC)
A common type of skin cancer that arises from the squamous cells in the outer layer of the skin. It often appears as a scaly red patch, open sore, or wart-like growth that may crust or bleed. CSCC can grow slowly but has the potential to spread to other parts of the body if not treated. It is primarily caused by prolonged exposure to ultraviolet (UV) radiation from the sun or tanning beds.
Basal Cell Carcinoma (BCC)
The most common form of skin cancer, originating in the basal cells of the skin. It usually appears as a small, shiny bump or nodule on areas of the skin that are frequently exposed to the sun, such as the face and neck. BCC grows slowly and rarely spreads to other parts of the body, but it can cause significant local damage if left untreated. It is primarily caused by long-term exposure to UV radiation.
Triple Negative Breast Cancer (TNBC)
A subtype of breast cancer that does not have the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER-2/neu. This makes it more challenging to treat, as hormone therapies and drugs that target HER-2 are ineffective. TNBC tends to be more aggressive and is more likely to spread and recur. It is more common in younger women and those with a BRCA1 gene mutation.
Non-Small Cell Lung Cancer (NSCLC)
The most common type of lung cancer, accounting for about 85% of cases. It includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. NSCLC typically grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. Smoking is the leading risk factor, but non-smokers can also develop NSCLC.