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PRGN-2009

BIOLOGICAL3 trials

Sponsors

National Cancer Institute (NCI)

Conditions

Anal CancerCancer VaccineCervical CancerDrug TherapyHPV Positive CancerHuman Papillomavirus VirusesOropharyngeal CancerOropharyngeal Squamous Cell Carcinoma (SCC)

Phase 1

HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers
Active, not recruitingNCT04432597
National Cancer Institute (NCI)Anal Cancer, Cervical Cancer, HPV Positive Cancer +2
Start: 2020-08-11End: 2026-03-31Updated: 2026-02-17

Phase 2

Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer
Active, not recruitingNCT05996523
National Cancer Institute (NCI)Oropharyngeal Squamous Cell Carcinoma (SCC)
Start: 2023-11-07End: 2030-07-16Updated: 2025-10-03
Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
RecruitingNCT06223568
National Cancer Institute (NCI)Cancer Vaccine, Drug Therapy, Human Papillomavirus Viruses +2
Start: 2024-06-10End: 2028-01-10Target: 70Updated: 2026-03-27

Related Papers

Phase II trial of neoadjuvant chemotherapy (NAC) docetaxel-cisplatin alone (DC) or with anti-human papillomavirus (HPV) gene therapy PRGN-2009 (DCP) followed by surgery in patients (pts) with newly diagnosed HPV-associated oropharyngeal cancer (HPV-OPC).
Journal of Clinical Oncology2025-05-28
PRGN-2009 and bintrafusp alfa for patients with advanced or metastatic human papillomavirus-associated cancer
Cancer Immunology Immunotherapy2025-03-215 citations
Phase II trial of immunotherapeutic HPV vaccine PRGN-2009 with pembrolizumab before standard treatment in subjects with newly diagnosed HPV-associated oropharyngeal cancer.
Journal of Clinical Oncology2024-06-011 citations
Abstract 1193: Peripheral immune analyses from phase I trial of HPV vaccine PRGN-2009 in combination with bintrafusp alfa in patients with HPV-associated cancers
Cancer Research2024-03-22
Phase I evaluation of PRGN-2009 alone and in combination with bintrafusp alfa in patients (pts) with recurrent/metastatic (R/M) HPV-associated cancers (HPV-C).
Journal of Clinical Oncology2023-06-019 citations
483 Initial safety results and immune responses induced by a novel human papillomavirus (HPV)-specific gorilla adenovirus immunotherapy vaccine, PRGN-2009, in patients with advanced HPV-associated cancers
Regular and Young Investigator Award Abstracts2021-11-013 citations
First-in-human phase I/II trial of PRGN-2009 vaccine as monotherapy or with bintrafusp alfa in patients with recurrent/metastatic (R/M) human papillomavirus (HPV)-associated cancers (HPVC) and as neoadjuvant/induction therapy in locoregionally advanced (LA) HPV oropharyngeal (OP) and sinonasal (SN) squamous cell cancer (SCC).
Journal of Clinical Oncology2021-05-203 citations