Clinical Trials Logo
  1. Home
  2. HPV-Related Cervical Carcinoma
  3. NCT03260023

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers

HPV-Related Carcinoma Clinical Trial

Official title:
A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies.

Clinical Trial Summary

The study will consist of two parts : In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-patient dose escalation. In the phase II part 1, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed in a single arm of patients with recurrent or metastatic HPV-16 positive advanced malignancies. In the phase II part 2, evaluation of efficacy of the combination of TG4001 and avelumab will be performed in a randomized, open-label controlled study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV-16 positive advanced malignancies. In both phases, tumor response will be evaluated on local assessment using RECIST 1.1. All patients will be followed up until disease progression, death, or unacceptable toxicity, or study withdrawal for any reason, whichever occurs first.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03260023
Study type Interventional
Source Transgene
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date September 11, 2017
Completion date December 2025
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT04001413 - Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients Phase 2
Recruiting NCT04857528 - Detecting HPV DNA in Anal and Cervical Cancers
Recruiting NCT05247853 - HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV
Completed NCT03033550 - Integrating Primary & Secondary Interventions for Cervical Cancer Prevention in Primary Care Settings N/A
Recruiting NCT05973487 - A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors Phase 1
Terminated NCT05061940 - This SCR-103 Protocol Will Permit Sites to Proactively Assess TAA, HLA and HPV-16 Status in Patients With Selected Solid Tumors to Determine Suitability for Repertoire Immune Medicines Treatment Protocols.
Recruiting NCT03475953 - A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors Phase 1/Phase 2
Recruiting NCT05686226 - E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers Phase 2
Recruiting NCT03795610 - Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma Phase 2
Recruiting NCT05814549 - A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)
Recruiting NCT05307939 - A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC) Phase 2
Recruiting NCT05262010 - A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years Phase 3
Recruiting NCT06157151 - PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer Phase 2
Completed NCT03749720 - HPV in Blood Samples From Cervical Cancer Patients. N/A
Not yet recruiting NCT05976828 - IBRX-042 In Subjects With HPV-Associated Tumors Phase 1
Not yet recruiting NCT05639972 - E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers Phase 1/Phase 2
Not yet recruiting NCT06454175 - A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese People Aged 18-45 Years Phase 1
Not yet recruiting NCT06465914 - A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males Phase 3
Active, not recruiting NCT03978689 - A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma Phase 1
Recruiting NCT06305676 - Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)