Not recruiting

Study on the Safety of Continued Treatment with GME751 (Pembrolizumab Biosimilar) for Patients with Melanoma or Non-Small Cell Lung 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 continued treatment with a medication called GME751, which is a proposed biosimilar to pembrolizumab. The study is designed for participants who have previously been treated with pembrolizumab in earlier studies and are eligible to continue this treatment. The diseases being studied in this trial are melanoma, a type of skin cancer, and non-small-cell lung cancer (NSCLC), which is a common type of lung cancer.

The purpose of the study is to assess the safety of ongoing treatment with GME751 by monitoring the occurrence of serious adverse events (SAEs). Participants will receive the treatment through an intravenous infusion, which means the medication is delivered directly into a vein. The study will follow participants for a period of up to 24 months to observe any potential side effects or reactions to the treatment.

In addition to GME751, some participants may have previously received another medication called Pemetrexed, which is used in combination with other treatments for certain types of cancer. The study is open-label, meaning both the researchers and participants know which treatment is being administered. This trial aims to provide valuable information on the safety of continuing treatment with GME751 for individuals with melanoma and NSCLC.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after signing an informed consent form. This confirms understanding and agreement to participate in the study.
Eligibility requires previous participation in Study 101 or Study 301, with a demonstrated benefit from continued treatment with pembrolizumab.
Step 2
Treatment administration
The treatment involves the administration of pembrolizumab and Pemetrexed STADA®.
Pembrolizumab is given as a concentrate for solution for infusion, administered intravenously.
Pemetrexed STADA® is a solution for infusion, also administered intravenously.
The frequency and dosage of these medications are determined by the study protocol and the healthcare provider.
Step 3
Monitoring and assessment
The main objective is to assess the safety of continued treatment with the proposed pembrolizumab biosimilar, focusing on the occurrence of serious adverse events (SAEs).
For participants with melanoma, SAEs are monitored for up to 6 to 12 months after starting treatment.
For participants with non-small-cell lung cancer (NSCLC), SAEs are monitored for up to 12 to 24 months after starting treatment.
Step 4
Completion of the study
The estimated end date for the study is September 30, 2027.
Participants will be informed about the completion of the study and any follow-up procedures if necessary.

Who can join the trial?

5 criteria

The patient must sign a document called an informed consent before joining the study. This document explains the study and confirms that the patient agrees to participate.
The patient must be at least 18 years old or the legal age of consent in the area where the study is conducted.
The patient must have participated in either Study 101 or Study 301 and be considered by their doctor to benefit from continuing treatment with a medication called pembrolizumab.
The patient must have followed the rules and requirements of Study 101 or Study 301, as determined by their doctor.
The patient must have either completed Study 101 or Study 301 according to the study plan or stopped treatment and study participation for specific reasons. For example, in Study 101, if the patient did not receive pembrolizumab within the scheduled time, or in Study 301, if the patient had severe side effects from chemotherapy drugs like Cisplatin, Carboplatin, or Pemetrexed.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer than Melanoma or Non-small-cell lung cancer cannot participate. Melanoma is a type of skin cancer, and non-small-cell lung cancer is a common type of lung cancer.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific characteristics in participants.
Patients who are not male or female cannot participate. The study includes both men and women.
Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those with certain health conditions.

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Verified sites

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

Centrul De Oncologie SF Nectarie S.R.L.
Verified
Craiova, Romania
Fundacion Instituto Valenciano De Oncologia
Verified
Valencia, Spain
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Responsive
Vilnius, Lithuania

Trial locations

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Investigated drugs

GME751 is a proposed biosimilar to pembrolizumab. It is being studied to see if it is safe for patients who have already been receiving pembrolizumab in previous studies. Pembrolizumab is a type of medication known as an immune checkpoint inhibitor, which helps the body's immune system fight cancer by blocking a specific protein that prevents immune cells from attacking cancer cells. This trial aims to ensure that GME751 can continue to provide similar benefits and safety as pembrolizumab for patients who need ongoing treatment.

What is already known about the treatment

Pembrolizumab – This medication is administered as an intravenous infusion, typically given in a clinical setting. It is currently well-established in medical literature and is used primarily for treating melanoma and non-small-cell lung cancer. Pembrolizumab works by blocking a specific protein on immune cells, allowing the immune system to better detect and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Melanoma
Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing the pigment melanin. It often appears as a new mole or a change in an existing mole, with irregular borders and multiple colors. Melanoma can grow quickly and has the potential to spread to other parts of the body if not detected early. It is more common in areas of the skin that have been exposed to the sun, but it can also occur in areas not typically exposed. The progression of melanoma can vary, with some cases remaining localized while others may metastasize. Early detection and monitoring of skin changes are crucial in managing this disease.
Non-small-cell lung cancer
Non-small-cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for a majority of cases. It typically starts in the epithelial cells lining the lungs and can grow slowly or rapidly, depending on the subtype. NSCLC is often diagnosed at an advanced stage because early symptoms can be mild or mistaken for other conditions. As the cancer progresses, it can invade nearby tissues and spread to other parts of the body, such as the bones or brain. The disease is categorized into several subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, each with distinct characteristics. Understanding the specific subtype is important for determining the course of the disease.