Clinical trial NCT05739006: Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies
Official title: A Multicenter, Double-Blind, Randomized Clinical Study to Evaluate the Pharmacokinetics and Safety of BCD-201 (JSC BIOCAD, Russia) and Keytruda® in Patients With Different Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Melanoma
Non Small Cell Lung Cancer
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical study BCD-201-1 is a double-blind randomized study of the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity of BCD-201 versus Keytruda following intravenous administration to subjects with advanced unresectable, metastatic, or recurrent melanoma and NSCLC.

The study aimed to establish the equivalence of PK and similarity of the safety, immunogenicity, and PD profiles of BCD-201 and Keytruda.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent;
* Body weight 60 to 90 kg;
* Histologically confirmed melanoma or NSCLC (patients with NSCLC are eligible to participate if high tumor PD-L1 expression \[≥50%\] is confirmed by local or central laboratory results);
* ECOG score 0-1;
* Laboratory test results consistent with adequate functioning of systems and organs;
* Willingness of males and females of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and within 6 months after the administration of the last product dose

Exclusion Criteria:

* Indications for radical therapy (surgery, radiation therapy);
* Previous systemic anti-tumor therapy for advanced unresectable, recurrent or metastatic melanoma or NSCLC (history of neoadjuvant or adjuvant therapy is acceptable provided that the treatment was completed at least 6 weeks prior to randomization);
* Active metastases in the central nervous system and/or carcinomatous meningitis;
* Patients with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis, bleeding or organ perforation) at the time of signing the informed consent and during the screening period;
* For patients with NSCLC: presence of activating EGFR mutations/ALK translocations;
* Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study;
* Active, known or suspected autoimmune disorders (subjects with type 1 diabetes mellitus or hypothyroidism requiring only hormone-replacement therapy and those with skin disorders \[vitiligo, alopecia, or psoriasis\] not requiring systemic therapy are eligible to participate);
* The need for therapy with glucocorticoids or any other drugs with immunosuppressive effects within 14 days prior to randomization;
* History of (non-infectious) pneumonitis requiring glucocorticoid therapy or pneumonitis at the time of screening;
* Hypersensitivity or allergy to any of the pembrolizumab product components;
* Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.

Primary outcomes:
measure: AUC(0-504) of pembrolizumab
timeFrame: pre-dose to week 25, 77 timepoints
Secondary outcomes:
measure: AUC(0-∞) of pembrolizumab
timeFrame: pre-dose to week 25, 77 timepoints
measure: Cmax
timeFrame: pre-dose to week 25, 77 timepoints
measure: Tmax
timeFrame: pre-dose to week 25, 77 timepoints
measure: T½
timeFrame: pre-dose to week 25, 77 timepoints
measure: Vd
timeFrame: pre-dose to week 25, 77 timepoints
measure: Cmin
timeFrame: pre-dose to week 25, 77 timepoints
measure: kel
timeFrame: pre-dose to week 25, 77 timepoints
measure: Cl
timeFrame: pre-dose to week 25, 77 timepoints
measure: Safety assessment
timeFrame: Day 1 to Day 169
measure: Immunogenicity assessment
timeFrame: pre-dose to week 25, 5 timepoints
measure: To compare the results of pilot assessment of BCD-201 and Keytruda efficacy
timeFrame: Day 1 to week 25
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: "Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
city: Omsk
country: Russian Federation
facility: Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
city: Saint Petersburg
country: Russian Federation
facility: State Budgetary Healthcare Institution "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"
Study officials:
References: