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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 121 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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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
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


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