Changeflow GovPing Pharma & Drug Safety PROSECCO Trial: Cemiplimab Combination for Mela...
Routine Notice Added Final

PROSECCO Trial: Cemiplimab Combination for Melanoma

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Detected April 6th, 2026
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Summary

ClinicalTrials.gov registered a new Phase III trial (NCT07511036) called PROSECCO, studying cemiplimab in combination therapy for melanoma. The trial is sponsored by Regeneron Pharmaceuticals and is currently listed as not recruiting. Cemiplimab is a PD-1 inhibitor marketed as Libtayo.

What changed

The PROSECCO trial has been registered on ClinicalTrials.gov under identifier NCT07511036. This is a clinical study investigating cemiplimab (Libtayo), Regeneron's PD-1 checkpoint inhibitor, in combination therapy for melanoma. The trial status is listed as 'not recruiting,' indicating the study has been registered but participant enrollment has not yet begun or is currently paused.

Pharmaceutical companies and clinical investigators involved in oncology trials should ensure their trial registrations are current and accurately reflect study status. Compliance with FDA requirements for clinical trial registration under FDAAA 801 and International Committee of Medical Journal Editors (ICMJE) requirements should be verified. Trial sponsors should update registration status promptly as enrollment progresses.

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Source

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Classification

Agency
NLM
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07511036

Who this affects

Applies to
Clinical investigators Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing 6211 Healthcare Providers
Activity scope
Clinical Trial Registration
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Pharmaceuticals Consumer Protection

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