RUENCN

BCD-100-8/FLAT

More about the molecule

Melanoma

The BCD-100-8/FLAT clinical study will evaluate the efficacy of prolgolimab in patients with unresectable or metastatic melanoma who:

  • Have documentary evidence of unresectable or metastatic melanoma.
  • Are aged 18 years or older.
  • Have not received anticancer therapy for unresectable or metastatic disease.
  • Are in a satisfactory overall condition (ECOG score 0-1).

This study has exclusion criteria (precluding participation in this clinical study), which will all be explained to the potential participant by the study doctor. In particular, exclusion criteria include:

  • CNS metastases, which are progressive or associated with clinical symptoms, or require the use of glucocorticoids and/or anticonvulsants.
  • The need for treatment with glucocorticoids or any other drugs with immunosuppressive effects.
  • Prior treatment with anti-CTLA4 and/or anti-PD-1/PD-L1/PDL-2 drugs.
  • Prior targeted drug therapy. Targeted drugs include BRAF inhibitors, MEK inhibitors, and other tyrosine kinase inhibitors.
  • A history of cancer, except for radically treated diseases with a remission of more than 5 years prior to study therapy.
  • Other concomitant diseases or conditions that may affect the safety of BCD-100 or preclude any of the necessary study procedures.

The BCD-100-8/FLAT study will take place in 16 study centers of different cities in the Russian Federation: Moscow, Saint Petersburg, Novosibirsk, and others.

You can ask questions about participation in the clinical study and request contact information about study centers using a special form «Do you have any questions?».



The study doctor will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study. The potential participant should read the full information about the study and consult the study doctor and/or attending physician.

Authorization of the Ministry of Health of the Russian Federation for this clinical study, No. 186 dated March 22, 2022, and the list of approved study centers have been published in the State Register of Medicines.