Ongoing Clinical Trials for Malignant Melanoma Stage II
Currently, there is 1 ongoing clinical trial for malignant melanoma stage II. This trial is investigating the safety of continued treatment with GME751, a proposed biosimilar to pembrolizumab, for patients who have previously participated in related studies. The trial is being conducted in multiple European countries and includes patients with both melanoma and non-small cell lung cancer.
Clinical trial locations
- Lithuania
- Romania
- Spain
Study on the Safety of Continued Treatment with GME751 (Pembrolizumab Biosimilar) for Patients with Melanoma or Non-Small Cell Lung Cancer
This clinical trial is being conducted in Romania, Spain, and Lithuania and focuses on patients who have stage II melanoma or non-small cell lung cancer. The trial is designed specifically for people who have already been receiving pembrolizumab treatment in previous studies and are eligible to continue this therapy.
Main inclusion criteria:
- Participants must be at least 18 years old or the legal age of consent in their country
- Must have previously participated in either Study 101 or Study 301 and be considered by their doctor to benefit from continuing treatment with pembrolizumab
- Must have signed an informed consent document before joining the study
- Must have followed the rules and requirements of their previous study
- Must have either completed their previous study according to the protocol or stopped for specific reasons, such as not receiving pembrolizumab within the scheduled time or experiencing severe side effects from chemotherapy drugs
Main exclusion criteria:
- Patients with cancer types other than melanoma or non-small cell lung cancer cannot participate
- Patients outside the specified age range cannot join
- Patients who were not part of the earlier specified clinical trials cannot participate
Focus and goal of the trial:
The primary purpose of this study is to assess the safety of continued treatment with GME751, a proposed biosimilar to pembrolizumab. A biosimilar is a medication that is highly similar to an already approved biological medicine. The study monitors the occurrence of serious adverse events in participants over an extended period. For patients with melanoma, monitoring takes place for 6 to 12 months after starting treatment, while for patients with non-small cell lung cancer, the monitoring period extends to 12 to 24 months. The trial will follow participants until its estimated completion date of September 30, 2027.
Investigational drug:
The main medication being studied is GME751, which is administered through an intravenous infusion, meaning it is delivered directly into a vein. GME751 is a proposed biosimilar to pembrolizumab, which is an immune checkpoint inhibitor. This type of medication helps the body’s immune system fight cancer by blocking a specific protein that normally prevents immune cells from attacking cancer cells. Some participants may also receive Pemetrexed STADA, a chemotherapy medication that is sometimes used in combination with pembrolizumab for certain types of cancer. The study is open-label, which means both the researchers and participants know which treatment is being given.
Summary
There is currently one ongoing clinical trial for malignant melanoma stage II, which is being conducted across three European countries: Romania, Spain, and Lithuania. This trial focuses on the safety of continued treatment with GME751, a proposed biosimilar to pembrolizumab, for patients who have already been receiving this therapy in previous studies. The trial is notable for including both melanoma and non-small cell lung cancer patients, with extended monitoring periods that can last up to 24 months depending on the type of cancer. The study represents an important step in understanding the safety profile of biosimilar medications for immunotherapy in cancer treatment.
