A clinical study to see to efficacy and safety of bcd-201 (Pembrolizumab) and Keytruda® for treatment in patients with unresolvable or evolved skin cancer.
- Conditions
- Health Condition 1: C439- Malignant melanoma of skin, unspecified
- Registration Number
- CTRI/2022/12/048496
- Lead Sponsor
- JSC BIOCAD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method