HPV-16 E7 protein inhib 
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28 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
ISA101 / ISA Pharma
NCT04646005 / 2020-001239-29: 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
2
113
Europe, US, RoW
Cemiplimab, REGN2810, Libtayo, ISA101b
Regeneron Pharmaceuticals, ISA Pharmaceuticals B.V.
Cervical Cancer
05/23
05/24
OpcemISA, NCT03669718 / 2018-000789-13: A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC

Active, not recruiting
2
194
Europe, US, RoW
ISA101b, Cemiplimab, Placebo
ISA Pharmaceuticals, Regeneron Pharmaceuticals
Squamous Cell Carcinoma of the Oropharynx, HPV16 Positive
09/24
06/25
ProcemISA, NCT04398524 / 2020-003652-32: A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC

Hourglass May 2024 - Jul 2024 : Mid'24 - Data from ISA101b-OPC-03-19 study in recurrent metastatic HPV16 induced HNC
Active, not recruiting
2
65
Europe, US, RoW
ISA101b, Cemiplimab
ISA Pharmaceuticals, Regeneron Pharmaceuticals
Squamous Cell Carcinoma of the Oropharynx
06/24
12/24
NCT04369937: HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma

Active, not recruiting
2
18
US
IMRT (Intensity Modulated Radiotherapy), Pembrolizumab, Cisplatin, ISA101b, HPV-16 Vaccine
Dan Zandberg, Merck Sharp & Dohme LLC, ISA Pharmaceuticals
HPV-Related Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma
06/25
06/26
bizalimogene ralaplasmid (VGX-3100) / Inovio
ChiCTR2300071848: A Randomized, Double-blind, Placebo-Controlled Study in China to evaluate the efficacy and safety of VGX-3100 Delivered Intramuscularly (IM) followed by Electroporation with CELLECTRA™ 5PSP for the Treatment of HPV-16 and/or HPV-18 related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix

Recruiting
3
84
 
6 mg (1 ml) VGX-3100 intramuscular injection followed by EP with the CELLECTRA 5PSP device given at Day 1, Week 4 and Week 12 ;Placebo intramuscular injection followed by EP with the CELLECTRA 5PSP device given at Day 1, Week 4 and Week 12
Chinese Academy of Medical Sciences Cancer Hospital; Beijing Apollo Saturn Biomedicine Technology Co. LTD, Beijing Apollo Saturn Biomedicine Technology Co. LTD
High Grade Squamous Intraepithelial Lesion of the Cervix
 
 
NCT03603808: VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions

Active, not recruiting
2
35
US
Electroporation, electroporation therapy, EPT, HPV DNA Plasmids Therapeutic Vaccine VGX-3100, VGX-3100, Laboratory Biomarker Analysis
AIDS Malignancy Consortium, National Cancer Institute (NCI), The Emmes Company, LLC, Inovio Pharmaceuticals
Anal Intraepithelial Neoplasia, High Grade Squamous Intraepithelial Neoplasia, HIV Positivity, Human Papillomavirus-16 Positive, Human Papillomavirus-18 Positive
01/26
01/27
tipapkinogene sovacivec (TG4001) / European Organization for Research and Treatment of Cancer, Transgene
TG4001.12, NCT03260023 / 2016-002799-28: Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers

Hourglass Jan 2020 - Jun 2020 : From trial in combination with TG4001
Checkmark Results in combination with TG4001 in Phase 1b part of trial
Dec 2018 - Dec 2018: Results in combination with TG4001 in Phase 1b part of trial
Active, not recruiting
1/2
150
Europe, US
TG4001, Avelumab
Transgene, Merck KGaA, Darmstadt, Germany, EMD Serono Research & Development Institute, Inc., Pfizer
HPV-Related Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma
12/24
12/25
Lovaxin C (axalimogene filolisbac) / Ayala Pharma
AIM2CERV, NCT02853604 / 2015-004844-20: Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer

Terminated
3
110
Europe, Canada, US, RoW
ADXS11-001, Placebo
Advaxis, Inc., Gynecologic Oncology Group
High Risk Cervical Cancer, Advanced Cervical Cancer
07/19
07/19
DPX-E7 / BioVaxys
NCT02865135: Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer

Completed
1/2
11
US
DPX-E7 vaccine, HPV vaccine, Cyclophosphamide, Cytoxan
Dana-Farber Cancer Institute, Stand Up To Cancer
Cancer of Head and Neck, Cancer of Cervix, Cancer of Anus
10/19
02/23
Versamune HPV / PDS Biotech
IMMUNOCERV, NCT04580771: A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the Trial

Active, not recruiting
2
22
US
Cisplatin, Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone''s Chloride, Peyrone''s Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin, Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101, mmunoMAPK-RDOTAP /HPV-16 E6/E7 Peptide Antigen Vaccine, PDS0101, Radiation Therapy, Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Locally Advanced Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IB3 Cervical Cancer FIGO 2018, Stage II Cervical Cancer FIGO 2018, Stage IIA Cervical Cancer FIGO 2018, Stage IIA1 Cervical Cancer FIGO 2018, Stage IIA2 Cervical Cancer FIGO 2018, Stage IIB Cervical Cancer FIGO 2018, Stage III Cervical Cancer FIGO 2018, Stage IIIA Cervical Cancer FIGO 2018, Stage IIIB Cervical Cancer FIGO 2018, Stage IIIC Cervical Cancer FIGO 2018, Stage IIIC1 Cervical Cancer FIGO 2018, Stage IIIC2 Cervical Cancer FIGO 2018, Stage IVA Cervical Cancer FIGO 2018
03/25
03/25
VERSATILE-002, NCT04260126: Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC

Checkmark Data from VERSATILE-002 clinical trial in combination with PDS0101 for metastatic head and neck cancer at MHNCS 2022
Feb 2022 - Feb 2022: Data from VERSATILE-002 clinical trial in combination with PDS0101 for metastatic head and neck cancer at MHNCS 2022
Active, not recruiting
2
95
Europe, US
Pembrolizumab (KEYTRUDA®) and PDS0101
PDS Biotechnology Corp., Merck Sharp & Dohme LLC
Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Neoplasms, Head and Neck
06/25
06/25
NCT04287868: Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

Active, not recruiting
1/2
51
US
PDS0101, M7824, MSB0011395C, NHS-IL12
National Cancer Institute (NCI)
Cervical Cancer, HPV Cancers, Anal Cancer, Oropharyngeal Cancer, Vulvar, Vaginal, Penile, Rectal Cancer
07/22
07/26
NCT05232851: A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer

Recruiting
1/2
24
US
Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101, mmunoMAPK-RDOTAP /HPV-16 E6/E7 Peptide Antigen Vaccine, PDS0101, Pembrolizumab, BCD-201, Biosimilar BCD-201, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography, CT, CT SCAN, tomography, FDG-Positron Emission Tomography, FDG, FDG-PET, FDG-PET Imaging, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Biopsy, BIOPSY_TYPE, Bx
Mayo Clinic
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Carcinoma, Locally Advanced Oropharyngeal Carcinoma, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
07/25
07/25
BNT113 / BioNTech
2020-001400-41: A clinical trial investigating the safety, tolerability, and therapeutic effects of BNT113 in combination with pembrolizumab versus pembrolizumab alone for patients with a form of head and neck cancer positive for human papilloma virus 16 and expressing the protein PD-L1

Not yet recruiting
2
285
Europe, RoW
BNT113 (RNA-LPX vaccine), Pembrolizumab, BNT113, N/A, Concentrate for solution for injection, Concentrate for solution for infusion, KEYTRUDA®
BioNTech SE, BioNTech SE
Unresectable recurrent, or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) which is positive for human papilloma virus 16 (HPV16+) and expresses PD-L1, Head and neck cancer positive for human papilloma virus 16 and expressing the protein PD-L1, Diseases [C] - Cancer [C04]
 
 
AHEAD-MERIT, NCT04534205: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

Recruiting
2
285
Europe, Canada, US, RoW
BNT113, Pembrolizumab
BioNTech SE
Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
05/28
05/28
HARE-40, NCT03418480: HPV Anti-CD40 RNA vaccinE

Completed
1/2
32
Europe
BNT113
University of Southampton, BioNTech SE
Human Papilloma Virus Related Carcinoma, Head and Neck Neoplasm, Cervical Neoplasm, Penile Neoplasms Malignant, Unknown Primary Tumors
11/23
01/24
ChiCTR2400087487: Observational study on the correlation between the immune response of patients' peripheral blood stimulated by therapeutic HPV mRNA vaccine in vitro and the pathological results and clinical prognosis of patients

Not yet recruiting
N/A
150
 
None
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine; Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, Self-financing
HPV
 
 
KITE-439 / Gilead, Fosun Pharma
NCT05041309 / 2020-005843-21: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Enrolling by invitation
2
700
Europe, Canada, Japan, US, RoW
Axicabtagene Ciloleucel, Yescarta®, Brexucabtagene Autoleucel, Tecartus™, KITE-585, KITE-718, KITE-439, KITE-222, KITE-363
Kite, A Gilead Company, Kite Pharma, Inc.
Solid and Hematological Malignancies
12/40
12/40
HB-201 / Hookipa Pharma
H-200-004, NCT06513884: A Phase 2/3 Study of HB-202/HB-201 With Pembrolizumab in Patients With HPV16+ Recurrent/Metastatic Oropharyngeal Cancer

Not yet recruiting
2/3
450
NA
HB-202/HB-201 alternating 2-vector therapy, HB-202 intravenous administration alternating with HB-201 intravenous administration, HB-201 & HB-202 two-vector therapy, TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV16+) Specific Antigens, Placebo, Matched placebo, Pembrolizumab, Keytruda®
Hookipa Biotech GmbH
Oropharyngeal Squamous Cell Carcinoma Recurrent
11/29
04/32
NCT06373380: A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC)

Recruiting
2
51
US
HB-200, Placebo
Memorial Sloan Kettering Cancer Center, Hookipa Biotech GmbH, Naveris
HPV16+ Squamous Cell Carcinoma
04/27
04/27
H-200-001, NCT04180215 / 2019-000907-34: A Phase 1/2 Study in Patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers

Active, not recruiting
1/2
200
Europe, US
HB-201 intravenous administration., HB-202 intravenous administration alternating with HB-201 intravenous administration., HB-201 intravenous administration + standard of care regimen including pembrolizumab., HB-202 / HB-201 alternating intravenous administration + pembrolizumab., HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab., HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)
Hookipa Biotech GmbH, Hookipa Biotech
HPV-Related Squamous Cell Carcinoma
06/25
06/26
NCT04630353: A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer

Terminated
1
10
US
HB-201 IV
Hookipa Biotech GmbH
HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer
11/23
11/23
eseba-vec (HB-200) / Hookipa Pharma
2019-000907-34: A clinical trial to test the regimen of two cancer treatment vaccines in patients with human papillomavirus 16 confirmed cancers. Un ensayo clínico para comprobar el régimen de dos vacunas para el tratamiento del cáncer en pacientes con cánceres de virus papiloma humano 16 confirmados

Not yet recruiting
1/2
200
Europe
HB -201, HB-202, Solution for injection/infusion, Concentrate for solution for infusion, Powder for concentrate for solution for infusion, KEYTRUDA 25 mg/ml concentrate for solution for infusion, KEYTRUDA 50 mg Powder for concentrate for solution for infusion
Hookipa Biotech GmbH, Hookipa Biotech
Human papilloma virus (HPV 16) associated cancer Cáncer asociado a virus papiloma humano (VPH 16), Diseases [C] - Cancer [C04]
 
 
TARGET-HPV, NCT05108870: TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers

Recruiting
1/2
98
US
HB-201, TheraT® Vectors, HB-202, Carboplatin, Paclitaxel, Transoral Robotic Surgery, TORS
University of Chicago
Human Papilloma Virus, HPV, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Head and Neck Cancer
01/26
01/26
TSC-200-A0201 / TSCan Therap
NCT05973487: A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors

Recruiting
1
100
US
TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-204-A0201 + TSC-204-C0702, TSC-204-A0201 + TSC-200-A0201, TSC-204-C0702 + TSC-200-A0201, TSC-204-A0201 + TSC-203-A0201, TSC-204-C0702 + TSC-203-A0201, TSC-200-A0201 + TSC-203-A0201, TSC-203-A0201, TSC-204-A0101, TSC-201-B0702, TSC-204-A0201 + TSC-204-A0101, TSC-204-A0201 + TSC-201-B0702, TSC-204-C0702 + TSC-204-A0101, TSC-204-C0702 + TSC-201-B0702, TSC-200-A0201 + TSC-204-A0101, TSC-200-A0201 + TSC-201-B0702, TSC-203-A0201 + TSC-204-A0101, TSC-203-A0201 + TSC-201-B0702
TScan Therapeutics, Inc.
Head and Neck Cancer, Cervical Cancer, Non-small Cell Carcinoma, Melanoma, Ovarian Cancer, Anogenital Cancers, HPV - Anogenital Human Papilloma Virus Infection, HPV-Related Cervical Carcinoma, HPV-Related Carcinoma, HPV-Related Squamous Cell Carcinoma, HPV-Related Malignancy, HPV-Related Adenocarcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Adenosquamous Carcinoma, HPV-Associated Vaginal Adenocarcinoma, HPV-Related Endocervical Adenocarcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Verrucous Carcinoma, HPV-Related Penile Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma, HPV Positive Rectal Squamous Cell Carcinoma
12/26
12/26
NEXI-003 / NexImmune
NCT05582590: Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers

Not yet recruiting
1
36
NA
Fludarabine, Fludara, Cyclophosphamide, Cytoxan, NEXI-003 T cells
NexImmune Inc.
Oropharyngeal Cancer, Human Papilloma Virus, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Cancer, Metastatic, Head and Neck Cancer Metastatic, HPV-Related Squamous Cell Carcinoma, HPV-Related Mucosal Head and Neck Squamous Cell Carcinoma, Relapsed Oropharyngeal SCC, Refractory Oropharyngeal Squamous Cell Carcinoma
07/26
08/27
SQZ-eAPC-HPV / STEMCELL Technologies
COMMANDER-001, NCT05357898: Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

Terminated
1/2
20
US
SQZ-eAPC-HPV, Pembrolizumab
SQZ Biotechnologies
Adult Solid Tumor
11/23
11/23
Vvax001 / ViciniVax
Vvax, NCT06015854 / 2019-004050-29: 001 Cancer Vaccine in Premalignant Cervical Lesions - Phase II

Recruiting
2
18
Europe
Vvax001 therapeutic cancer vaccine
University Medical Center Groningen, Dutch Cancer Society, ViciniVax B.V
CIN3, Cervical Intraepithelial Neoplasia, Cervical Intraepithelial Neoplasia Grade 3, HPV 16 Infection
02/24
04/24

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