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Therapy Name	Cemiplimab + ISA101b
Synonyms
Therapy Description	ISA101b is an HPV16 vaccine comprised of a peptide string that includes the E6 and E7 HPV proteins and T cell epitopes, allowing for T-cell activation, and may result in antitumor activity (PMID: 27669306).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Cemiplimab	Libtayo	REGN2810\|SAR439684	Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 129	Libtayo (cemiplimab) is a human antibody that targets PD-1 (PDCD1) and prevents interaction with PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in increased anti-tumor immune response and decreased tumor growth (PMID: 28265006). Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation, in patients with locally advanced or metastatic basal cell carcinoma who have received or are not eligible for a hedgehog pathway inhibitor, as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations, and in combination with platinum-based chemotherapy as first-line treatment for patients with NSCLC without EGFR, ALK, or ROS1 alterations (FDA.gov).
ISA101b		ISA-101b\|ISA 101b		ISA101b is an HPV16 vaccine comprised of a peptide string that includes the E6 and E7 HPV proteins and T cell epitopes, allowing for T-cell activation, and may result in antitumor activity (PMID: 27669306).

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT03669718	Phase II	Cemiplimab + ISA101b Cemiplimab	A Randomized Phase 2 Study of Cemiplimab +/- ISA101b in HPV16-Positive OPC	Active, not recruiting	USA \| POL \| NLD \| ITA \| HUN \| GBR \| FRA \| ESP \| DEU \| CZE \| BRA \| BEL	1
NCT04398524	Phase II	Cemiplimab + ISA101b	A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC	Active, not recruiting	USA \| ITA \| ISR \| GBR \| FRA \| ESP \| DEU \| CZE \| BEL	0
NCT04646005	Phase II	Cemiplimab + ISA101b	Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy	Completed	USA \| NLD \| ITA \| ESP \| BRA \| BEL	2

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