HPV-Related Cervical 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.
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04083196 -
A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
|
Phase 1 | |
| Recruiting |
NCT05829629 -
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
|
Phase 1 | |
| Recruiting |
NCT06052033 -
Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection
|
N/A | |
| Recruiting |
NCT04857528 -
Detecting HPV DNA in Anal and Cervical Cancers
|
||
| Recruiting |
NCT03749707 -
HPV in Sentinel Lymph Nodes
|
N/A | |
| Recruiting |
NCT05314907 -
Acceptability of Self-sampling for Cervical Cancer Screening
|
N/A | |
| Completed |
NCT04679675 -
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
|
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 |
NCT05783167 -
Self-collected Vaginal and Urine Samples in HIV-positive Women
|
||
| Recruiting |
NCT05996783 -
Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial
|
N/A | |
| Active, not recruiting |
NCT06339684 -
HPV Immunological Markers of Cervical Persistent Infection and Oncogenesis
|
||
| Recruiting |
NCT05686226 -
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
|
Phase 2 | |
| Not yet recruiting |
NCT06319963 -
A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT05767138 -
STI Knowledge and HPV Vaccine Acceptance in Bamako, Mali in 2012
|
||
| Completed |
NCT04970394 -
An Observational Study of GP Verbal Reminders Upon Cervical Screening
|
||
| Completed |
NCT03337269 -
Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake
|
N/A | |
| Completed |
NCT04436133 -
Immunogenicity AND Safety Study of the 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
|
Phase 2 | |
| Completed |
NCT04480866 -
CASUS: Improved and Quality Assured Collection of First-void Urine
|
N/A | |
| Recruiting |
NCT03055130 -
HPV Infection and Cervical Neoplasm in Women With Inflammatory Bowel Disease: a Cross-sectional Study
|
N/A |