Quantum Leap Healthcare Collaborative

Agent Information

The I-SPY Program is committed to open science, through timely publication and release of results, and ultimately data, from all arms of our trials.
I-SPY Trial Manuscript
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Trade Name:
Currently Enrolling
Treatment Protocol:
Cemiplimab iv 350 mg q3w x 4 with paclitaxel administered at 80 mg/m2 q1w x 12. This regimen is followed by AC (q2w or q3w) for 4 weeks.
Date Entered I-SPY:
February 13, 2020
Date Left I-SPY:
No. Participants in Arm:
Graduating Subtypes:
Agent Description:

Cemiplimab (REGN2810, Libtayo®) is a humanized, hinge-stabilized, IgG4K monoclonal antibody (mAb) designed to target PD-1-expressing cells, including T cells, and sustain or restore their effector function by blocking checkpoint inhibitory interactions between PD-1 and its ligands (PD-L1 and PD-L2). It has received approval for the treatment of patients with metastatic or some locally advanced cutaneous squamous cell carcinomas.

Final pCR Probabilities:
Primary Manuscript:
abstractpdfdoi link