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Evx-01

A new clinical trial is exploring the potential of EVX-01, an investigational drug, when used in combination with pembrolizumab (Keytruda) for patients with advanced melanoma. This study aims to assess the effectiveness and safety of this combination therapy in patients with unresectable or metastatic melanoma who have not previously received checkpoint inhibitor treatment.

Table of Contents

What is EVX-01?

EVX-01 is an investigational drug that is being studied for the treatment of advanced melanoma, a serious form of skin cancer[1]. It is designed to work in combination with another medication called pembrolizumab (also known by its brand name Keytruda)[1]. The purpose of this combination therapy is to potentially enhance the body’s immune response against melanoma cells.

Target Conditions

The clinical trial for EVX-01 is specifically targeting patients with two advanced stages of melanoma[1]:

  • Melanoma Stage III: This stage indicates that the cancer has spread to nearby lymph nodes but not to distant parts of the body.
  • Melanoma Stage IV: This is the most advanced stage, where the cancer has spread to distant organs or lymph nodes far from the original tumor site.

The trial focuses on patients with unresectable (unable to be removed by surgery) or metastatic (spread to other parts of the body) melanoma[1].

Treatment Approach

The treatment approach in this clinical trial combines two key elements[1]:

  1. Pembrolizumab (Keytruda): This is a standard treatment for melanoma that works by helping the immune system recognize and attack cancer cells. Patients will receive this medication for up to 18 treatment cycles (approximately 2 years).
  2. EVX-01: This investigational drug is administered as a series of injections into the muscle (intramuscularly). The treatment schedule includes:
    • 6 initial doses given two weeks apart
    • 4 additional booster doses given at later time points

The EVX-01 treatment begins at Week 12 of the trial, after patients have already started receiving pembrolizumab[1].

Clinical Trial Details

The clinical trial for EVX-01 is designed as an open-label, single-arm trial[1]. This means that all participants receive the same treatment (EVX-01 plus pembrolizumab), and both the patients and doctors know which treatment is being given. The trial aims to evaluate how well this combination works compared to historical data of patients treated with pembrolizumab alone.

Key aspects of the trial include[1]:

  • It is a multi-national study, involving patients from different countries.
  • The trial focuses on patients who have not previously received checkpoint inhibitor treatment (treatment-naïve).
  • The total duration of the study is up to 102 weeks (approximately 2 years).

Expected Outcomes

The clinical trial aims to measure several important outcomes to determine the effectiveness of EVX-01 in combination with pembrolizumab[1]:

  1. Best Overall Response (BOR): This is the main goal of the study. It looks at how well tumors respond to the treatment, including whether they completely disappear (complete response) or shrink significantly (partial response).
  2. Overall Response Rate: This measures the proportion of patients whose tumors either completely disappear or shrink significantly.
  3. Progression-Free Survival (PFS): This looks at how long patients live without their cancer getting worse.
  4. Overall Survival (OS): This measures how long patients live after starting the treatment.

Additionally, the trial will assess the immunologic response induced by EVX-01. This means they will look at how the treatment activates specific immune cells (CD4+ and CD8+ T-cells) that can recognize and attack the cancer cells[1].

Safety Considerations

As with any new treatment, safety is a crucial aspect of the EVX-01 clinical trial. The researchers will carefully monitor and record any side effects or adverse events that patients experience during the study[1]. This includes:

  • The number of side effects
  • The types of side effects
  • The severity of side effects

Both minor side effects (adverse events) and more serious complications (serious adverse events) will be tracked throughout the entire study period[1].

Manufacturing Feasibility

An interesting aspect of this trial is that it also aims to evaluate the manufacturing feasibility of EVX-01[1]. This means the researchers will track how often they can successfully create and administer the personalized treatment for each patient. This information is crucial for understanding whether EVX-01 could potentially be produced on a larger scale if it proves effective.

Aspect Details
Study Type Single arm, multi-national clinical trial
Participants Adults with unresectable or metastatic melanoma (Stage III or IV)
Treatment EVX-01 in combination with pembrolizumab
Duration Up to 102 weeks (2 years)
Primary Outcome Change in best overall response (BOR)
Secondary Outcomes Overall response rate, progression-free survival, overall survival, safety assessment, immunologic response
EVX-01 Administration 10 doses intramuscularly (6 doses every 2 weeks, 4 booster doses later)
Pembrolizumab Administration According to label, up to 18 treatment cycles

FAQ

  • What is the purpose of this clinical trial? The trial aims to evaluate the effectiveness and safety of EVX-01 in combination with pembrolizumab in patients with metastatic or unresectable melanoma, comparing the results to historical data of patients treated with pembrolizumab alone.
  • Who can participate in this trial? The trial is designed for adults with unresectable (unable to be surgically removed) or metastatic (spread to other parts of the body) melanoma who have not previously received checkpoint inhibitor treatment.
  • How long does the treatment last? Patients will receive pembrolizumab for up to 18 treatment cycles (approximately 2 years). EVX-01 immunization starts at Week 12, with a total of 10 doses administered over the course of the treatment.
  • What are the main outcomes being measured in this trial? The primary outcome is the change in best overall response (BOR), which includes complete or partial responses to the treatment. Secondary outcomes include overall response rate, progression-free survival, overall survival, and safety assessments.
  • How is EVX-01 administered? EVX-01 is administered intramuscularly (injected into a muscle). Patients will receive 6 doses given two weeks apart, followed by 4 booster doses at later time points.

Ongoing Clinical Trials on Evx-01

  • Study on the Effects of EVX-01 and Pembrolizumab in Adults with Advanced Melanoma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Melanoma: A type of skin cancer that develops in cells called melanocytes, which produce melanin (the pigment that gives skin its color).
  • Unresectable: Unable to be removed surgically, often due to the location or extent of the cancer.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Pembrolizumab (Keytruda): A type of immunotherapy drug known as a checkpoint inhibitor, used to treat various types of cancer, including melanoma.
  • EVX-01: An investigational drug being studied in combination with pembrolizumab for the treatment of advanced melanoma.
  • Intramuscular: A method of administering medication by injecting it directly into a muscle.
  • Best Overall Response (BOR): A measure of how well a patient responds to treatment, including complete response (disappearance of all signs of cancer) or partial response (decrease in tumor size).
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it worsening.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure.
  • Serious Adverse Events (SAEs): An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • RECIST 1.1 criteria: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.

References