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Clinical Trials/CTRI/2022/12/048496
CTRI/2022/12/048496
Active, not recruiting
Phase 3

A Randomized, Double-Blind Clinical Study of the Efficacyand Safety of BCD-201 (JSC BIOCAD) and Keytruda® inPatients with Unresectable or Metastatic Melanoma

JSC BIOCAD0 sites0 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
JSC BIOCAD
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
JSC BIOCAD

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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