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Long term follow up of the clinical and immunological responses following HPV 16 E6/E7 synthetic long peptides vaccination in women with HPV 16 positive vulvar intraepithelial neoplasia grade 3

To determine the long term clinical and immunological responses in patients with high grade VIN who have been vaccinated with an HPV 16 E6/E7 SLP vaccine approximately 3 years ago.

Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of patients with platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens

The primary purpose of the study is to determine the efficacy of AZD2281 compared to placebo in serous ovariancancer platinum sensitive patients and in a defined HRD subset.

ENGOT-ov11/MILO study (MEK Inhibitor in Low-grade Serous Ovarian Cancer):
A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician*s Choice Chemotherapy in Patients with Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum

Primary: • Demonstrate superior efficacy (increased progression-free survival [PFS]) of MEK162 vs. physician*s choice of selected chemotherapies (liposomal doxorubicin, paclitaxel and topotecan)Key Secondary: • Demonstrate superior efficacy (…

A multicenter, open label Phase I/II study to determine the safety and immune modulating effects of the therapeutic Human Papilloma Virus Type 16 (HPV16) E6/E7 Synthetic Long Peptides Vaccine (ISA101/ISA101b) immunotherapy in combination with standard of care therapy (carboplatin and paclitaxel with or without bevacizumab) in women with HPV16 positive advanced or recurrent cervical cancer who have no curative treatment options.

Primary objectives: • To assess the safety and tolerability of different doses of the ISA101 vaccine with or without pegylated IFNα as combination therapy with carboplatin and paclitaxel.• To qualitatively assess the safety profile of ISA101b…

POLE EC pilot study: Identification of neo-antigen specific immunity in POLE-mutant endometrial cancer

The purpose of this project is to investigate the presence and course of neo-antigen specific immunity in patients with polymerase epsilon (POLE) mutated endometrial cancer, with the intent to exploit the obtained knowledge of neo-antigen specific…

Phase 1 study of cisplatin/hyperthermia/lapatinib in patients with previously irradiated recurrent carcinoma of the uterine cervix.

This phase I study aims to define the MTD of the combination of cisplatin/hyperthermia/lapatinib, to confirm that the 2 agents combined with hyperthermia can be administered safely, and to recommend a dose for further clinical studies.

A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer

There is still no level I-II evidence for cytoreductive surgery in recurrent ovarian cancer. This is also the conclusion of a Cochrane Review of Galaal et al. published in June 2010. The most active chemotherapy in platinum sensitive recurrent…

Immunological aspects of combined chemotherapy and immunotherapy with HPV16 E6/E7 Synthetic Long Peptide vaccination in patients with advanced cervical cancer.

The final aim of the research project is to investigate the optimal time (*window*) for vaccination after chemotherapy.• To explore the optimal time-window to start immunotherapy after chemotherapy;• To study the time-related immune response to…

A randomized phase II trial of docetaxel plus carboplatin versus docetaxel in hormone refractory prostate cancer patients who have progressed after response to prior docetaxel chemotherapy: RECARDO STUDY

Primary objectives:* Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first:o PSA progression o Progressive disease according to RECIST when measurable diseaseSecondary objectives:* Toxicity profile.*…

The immunological aspects of conventional therapies for the treatment of cervical cancer. An exploratory study to monitor the immunological effects of radiotherapies in cervical cancer patients

To monitor the effects of radiotherapy alone, chemoradiation and radiotherapy combined with hyperthermia on the immune response and different T cell subsets over time in patients with cervical cancer.

A phase I-II open label clinical trial, evaluating the efficacy and safety of administration of the therapeutic vaccine PEP-223/CoVaccine HT, to hormone treatment naive, immunocompetent subjects with T1-3, N0-1/x, M0 prostate cancer, eligible for hormone therapy.

primary aim of the study To investigate the efficacy of PEP-223/CoVaccine HT in decreasing serum testosterone levels to below castrate levels, i.e. to < 2 nmol/l, within 8 weeks after the last of three injectionssecondary aims of the studyTo…

A two-part, randomized Phase II, double-blind, multicenter trial assessing the efficacy and safety of pertuzumab in combination with standard chemotherapy vs. placebo plus standard chemotherapy in women with recurrent platinum resistant epithelial ovarian cancer and low HER3 mRNA expression

PRIMARY OBJECTIVEPart 1: Safety Run-in PhaseThe primary objective for Part 1 of this study is to determine the safety and tolerability of pertuzumab in combination with either topotecan or paclitaxel.Part 2The primary objective for Part 2 of this…

A RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL COMPARING IPILIMUMAB VS. PLACEBO FOLLOWING RADIOTHERAPY IN SUBJECTS WITH CASTRATION RESISTANT PROSTATE CANCER THAT HAVE RECEIVED PRIOR TREATMENT WITH DOCETAXEL

The objective of this study is to compare the overall survival of patients with castration resistant prostate cancer who have progressed after receiving docetaxel treatment, when they are treated with bone directed radiotherapy plus Ipilimumab…

A phase 1b/2 study with the agonistic TRAIL-R1 antibody, mapatumumab, in combination with cisplatin and radiotherapy as a first line therapy in patients with advanced cervical cancer

Primary objective:Phase 1b:-To evaluate the safety and tolerability of escalating doses of mapatumumab in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer.Phase 2:-To evaluate the efficacy of mapatumumab…

An observational controlled study on vaginal blood flow, sexual functioning, bladder and bowel function after radiation therapy following nerve-sparing radical hysterectomy for early stage cervical cancer (FIGO IA2-IIA).

In this controlled (studygroups from P05-095 will serve as controls) observational study, the effects of radiation therapy after nerve-sparing radical hysterectomy for early stage cervical cancer on sexual function, bladder and bowel function is…

Predictive factors and pharmacokinetics of intraperitonal chemotherapy

Primary:• In this project, we propose to study the use of this aspiration fluid from the intraperitoneal cavity as a biomarker for the efficacy of chemotherapy intervention.The research questions for this study are:• Monitor the effect of…

Immune modulating effects and safety of Vvax001, a therapeutic Semliki Forest Virus based cancer vaccine, in patients with a history of (pre) malignant cervical lesions.

The objective of this trial is to assess the immunological activity of Vvax001 by monitoring HPV-16 specific immune responses in order to determine the optimal dose inducing the highest immune responses.

A phase III Trial of postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk endometrial cancer.

To demonstrate efficacy of adjuvant combination chemotherapy in a randomized phase III trial comparing to no further treatment in the medium and high-risk node negative stage I and stage II patients.

Repeated CT study in patients with cervical cancer to assess organ motion for adaptive radiotherapy and proton therapy planning

To develop a strategy for online-adaptive radiotherapy with protons in patients with cervical cancer.

Uterine Cervix repeated Magnetic Resonance Imaging for adaptive treatment planning of cervical cancer radiotherapy. A single-center study

To develop an MRI-guided adaptive radiotherapy workflow for patients with locally advanced cervical cancer, aimed at achieving more precise target coverage and better critical organ sparing.