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A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…

Randomised controlled study comparing AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent or metastatic endometrial cancer

1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…

Pretherapeutic para-aortic lymphadenectomy in advanced stage cervical cancer.

1. To study the safety and feasibility of para-aortic surgical staging in advanced cervical cancer in the Netherlands.2. To provide insight in the possible effectiveness of para-aortic surgical staging in advanced cervical cancer as compared to…

A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.

* To demonstrate efficacy of the candidate vaccine in the prevention of (1) persistent infection (6-month definition) with HPV-16 or HPV-18 (by polymerase chain reaction [PCR]) and/or (2) histopathologically-confirmed CIN1+ associated with HPV-16 or…

The long-term immune response after HPV16 peptide vaccination in woman with low-grade pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

Evaluation of the capacity of a HPV 16 peptide vaccine to install a long term HPV-specific T cell response, to define the importance of a booster vaccine after 1 year, the induction of Cytotoxic T lymphocyte (CTL) immunity against HPV16E6 and E7 and…

The effect of HPV16 peptide vaccination on the local immune response in woman with high grade HPV16+ pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

This study aims to reveal whether vaccination of women with HPV 16+ cervical intraepithelial neoplasia not only results in a strong systemic T-cell response, but also endows these T-cells with the capacity to infiltrate HPV16-induced lesions.…

Sentix: A prospective observational trial on sentinel lymph node biopsy in patients
with early stage cervical cancer

To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy.The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the…

A RANDOMIZED TRIAL COMPARING RADICAL HYSTERECTOMY AND PELVIC
NODE DISSECTION VS SIMPLE HYSTERECTOMY AND PELVIC NODE DISSECTION
IN PATIENTS WITH LOW RISK EARLY STAGE CERVICAL CANCER

Primary objective:To evaluate whether treatment with simple hysterectomy and pelvic node dissection is non-inferior to treatment with radical hysterectomy and pelvic node dissection in terms of pelvic relapse-free survival.Secondary objectives:To…

A double blind, prospective, randomized, placebo controlled, multi-center phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions (HSIL)

The purpose of the study is to evaluate the efficacy and safety of Cevira® compared to placebo in treatment of patients with cervical histologic HSIL.

Phase 3 study of ADXS11-001 administered following chemoradiation as adjuvant treatment for high risk locally advanced cervical cancer: AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence)

Primary objective:- Disease free survival (DFS)Secondary objective:- Safety & tolerability- Overall survival (OS)Exploratory objective:- Association between HPV subtypes and efficacy- Patient reported outcomes (PRO)Please refer to section 1…