A Randomized, Double-Blind Clinical Study of the Efficacyand Safety of BCD-201 (JSC BIOCAD) and Keytruda® inPatients with Unresectable or Metastatic Melanoma
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 366
- Locations
- 10
- Primary Endpoint
- To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group.
Study Overview
Brief Summary
Pembrolizumab was approved formedical use in 2014 (USA). Since then, this product, together with other immunecheckpoint inhibitors, have radically changed the approach to cancer treatment.Due to emerging data of an unprecedentedly high number of clinical studies ofpembrolizumab, new indications have been approved. At the time of writing thisProtocol, the indications approved in the India, Russian Federation, EU, USAand other countries include melanoma, NSCLC, head and neck cancer, classicalHodgkin lymphoma, urothelial cancer, microsatellite instability-high cancer, cervicalcancer, renal cell carcinoma, endometrial cancer, colorectal cancer, triplenegative breast cancer. Moreover, it should be noted that the results of morethan a thousand other clinical studies of this drug are expected, which willlead to the registration of new indications in the following years.
Noteworthy, pembrolizumab isalready indicated for most cancer patients. Considering that malignancies areone of the leading causes of death among all diseases worldwide, including in Russia,the importance of pembrolizumab for the population cannot be overestimated. The main barrier for the widespreaduse of pembrolizumab is its cost. It should be noted that most patients who need this drugcannot receive it at this time. This trend is observed globally for all novelanti-tumor drugs. The only effective solution for this problem is to developbiosimilars that ensure the same efficacy and safety at a lower cost and thuscan be made available to a wider population.
Based on the above, it can beconcluded that the development of pembrolizumab biosimilar is justified and will meet theclinical need of the population for a highly effective anti-cancer therapy.
This study aimed at confirming thebiosimilarity of BCD-201 and Keytruda when used as firstline therapy in subjectswith unresectable or metastatic skin melanoma in terms of the efficacy and safety.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age ≥18 years at the signing of the informed consent form.
- •Histologically confirmed melanoma.
- •Tumor first detected at the stage of advanced unresectable or metastatic disease, or disease progressing during or recurring after previous radical therapy.
- •At least one measurable lesion according to RECIST 1.1 based on central review.
- •ECOG score 0–1.
Exclusion Criteria
- •Indications for radical therapy (surgery, radiation therapy).
- •Uveal melanoma or mucosal melanoma.
- •Previous systemic anti-tumor therapy for advanced unresectable, recurrent or metastatic skin melanoma (history of neoadjuvant or adjuvant therapy is acceptable provided that the treatment was completed at least 6 weeks prior to randomization).
- •Active CNS metastases and/or carcinomatous meningitis.
- •Subjects with brain metastases are eligible to participate provided that the metastases have been adequately treated with surgery or radiation therapy only and are stable based on the results of imaging assessments.
- •Previous invasive malignancy with any evidence of the disease within the last 3 years.
- •Participants with non-melanoma skin cancer or carcinoma in situ (e.g., breast cancer) who have undergone radical therapy are not excluded.
Outcomes
Primary Outcomes
To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group.
Time Frame: week 1 to week 25
Secondary Outcomes
- To compare the secondary efficacy endpoints, safety profiles, pharmacokinetics, immunogenicity of BCD-201 and Keytruda(week 1 to week 25)