Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551064
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Multicenter Pharmacokinetic Equivalence Clinical Trial of Adjuvant FYB206 Keytruda Biosimilar Candidate in Comparison With Keytruda Pembrolizumab to Demonstrate Pharmacokinetic Similarity in Patients With Completely Resected Stage IIBIIC or Stage III Melanoma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dahlia
Brief Summary:
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 bodys 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 IIBIIC or Stage III melanoma
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 bodys 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 IIBIIC or Stage III melanoma
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None