Melanoma is a kind of skin cancer that starts in the melanocytes. Melanocytes are cells that make the pigment that gives skin its colour. 'Resected' means the melanoma has been completely removed with surgery. Pembrolizumab is an anti-cancer therapy that works with the immune system to fight cancer cells. Some cancer cells develop a way to hide from the body's immune system and, thus, allow the cancer cells to spread and grow. Pembrolizumab helps the immune system recognize and kill these cancer cells that want to hide. Pembrolizumab is a biologic drug (produced by living organisms) available in the market under the brand name Keytruda. Keytruda is approved globally for the treatment of a variety of cancers and as an addon or after therapy to primary cancer treatment like surgery. This helps prevent the cancer from returning, improving overall survival. FYB206 is a proposed biosimilar to Keytruda. A biosimilar is not identical but very similar to its original biologic. Biosimilars are expected to have a similar effect and safety to the original biologic. To learn what happens to a drug once it is in the body is called pharmacokinetics (PK). PK for biosimilar drugs is expected to remain similar to the original biologic. This study is to show that PK of FYB206 is similar to the reference product Keytruda for patients with completely resected Stage IIB/IIC or Stage III melanoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
Formycon Investigative Site
Sarajevo, Bosnia and Herzegovina
Formycon Investigative Site
Sofia, Bulgaria
Formycon Investigative Site
Tartu, Estonia
Formycon Investigative Site
Batumi, Georgia
Formycon Investigative Site
Kutaisi, Georgia
Formycon Investigative Site
Tbilisi, Georgia
Formycon Investigative Site
Kaunas, Lithuania
Formycon Investigative Site
Chisinau, Moldova
Formycon Investigative Site
Skopje, North Macedonia
Formycon Investigative Site
Krakow, Poland
...and 7 more locations
AUCtau,sd at Cycle 1
Area under the concentration curve for one dosing interval (tau=21 days) after a single (initial) dose (AUCtau,sd) of FYB206 and Keytruda (Cycle 1)
Time frame: 21 days
AUCtau,sd at Cycle 6
Area under the concentration curve for one dosing interval (tau=21 days) at steady state (AUCtau,ss) of FYB206 and Keytruda (Cycle 6)
Time frame: 126 days
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