Dear Colleagues
Welcome to the Spring edition of the UZA newsletter!

On the following pages we would like to present you our staff and focus on the vision and goals of our Clinical Trials Unit.

In addition, we would very much like to provide an update and overview on the clinical trials that are currently running at UZA and draw your attention to some particular studies.

We hope that the following pages will serve to be informative.

Beste Collega's
Welkom bij de lente editie van de UZA nieuwsbrief!

Op de volgende pagina’s vindt u een korte voorstelling van onze staf en medewerkers alsook schetsen we een duidelijk beeld van de visie en doelstellingen van onze Clinical Trial Unit.
Tot slot geven we u een compleet overzicht van het aanbod klinische studies die momenteel op het Universitair Ziekenhuis Antwerpen (UZA) lopen.

We hopen dat u deze nieuwsbrief informatief vindt.

Chers Collègues
Bienvenue à l’édition de printemps du bulletin d’UZA!

Sur les pages suivantes, nous voudrions vous présenter notre personnel et mettre l’accent sur la vision et les buts de notre unité des essais cliniques.
En plus, nous aimerions beaucoup vous présenter un résumé complet de toutes les essais cliniques qui sont actuellement actifs à UZA et attirer votre attention sur certaines études particulières.

Nous espérons que les pages qui suivent serviront à être informatifs.

We would like to inform you that since April 2018, Prof. Dr. Rolfo is not longer working at UZA, due to a new position in US. He is appointed as Director of Early Clinical Trials and Director of Thoracic Medical Oncology at The University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) in Baltimore. We are happy to announce that Prof. Hans Prenen from Leuven University will be the new director of Early Clinical Trials and Director of Clinical Trials Management Program, as from the 2nd of May 2018.

Prof. Dr. Hans Prenen obtained his medical degree in 2001 from the Catholic University Leuven (K.U. Leuven, Belgium) and did his residency in the Department of Oncology at the University Hospitals Gasthuisberg, Leuven (Belgium) with a focus on phase 1 clinical trials. In 2006, he obtained his PhD from the program in molecular oncology at the laboratory of experimental oncology at K.U Leuven. Since 2009 he is working in the division of gastroenterology at the University Hospitals Leuven in the field of digestive oncology. He is currently an Associate Professor of Medicine at the K.U. Leuven as well as a Senior Clinical Investigator of the Belgian Foundation against Cancer with a research focus on basic and translational research in the field of digestive oncology. Prof. Prenen is board member of the Belgian Society of Medical Oncology (BSMO) and member of several scientific organizations. Moreover, he is regularly invited for lectures in national and international meetings. He has published more than 100 peer reviewed scientific papers (H-index: 31, citations: 4865) in prestigious journals including Nature, Nature Genetics, New England Journal of Medicine, Lancet, Lancet Oncology, Journal of Clinical Oncology, Gastroenterology and Gut.

We would like to thank Prof. Dr. Rolfo for his hard work and dedication and wish him all the best in his future career !

We welcome Prof. Dr. Prenen and we wish him good luck in his new position here at UZA!

In UZA, at MOCA (Multidisciplinary Oncology Center Antwerp) our ultimate goal is to find new, better and more effective treatments in order to help cancer patients live longer and have better lives.

Clinical research trials are key to develop new methods to prevent, detect, and treat cancer.

Patient participation in clinical trials is an essential factor in this process. The cancer treatments that we use today started with research. It is through these trials that researchers can determine whether new treatments are safe and effective and work better than current treatments.

We sincerely appreciate your involvement and contribution and warmly invite you to learn more about our clinical trials in this newsletter.

Thanks for your continued collaboration!

Several trials, ranging from phase I to IV are active to include patients. For your convenience,          please find a list of these trials categorized by tumor type here under:         Phase I trials                         Bone and Soft tissue sarcoma    Melanoma trials          Gastroenterological trials    Gynaecological trials                   Breast trials          Head and Neck trials            Neurological/Brain trials              Lung/Thoracic trials          Genitourinary trials              Pediatric trials

Highlighted trials:

NEKTAR 16-214-02 (NKTR-214-PIVOTO2)

A Phase 1/2, Open-label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Ipilimumab in Patients with Select Locally Advanced or Metastatic Solid Tumor Malignancies.  Note: Cohorts RCC (I-O therapy relapse/refractory), NSCLC (I-O therapy naive) and Urothelial (I-O therapy naive) are open.

TVEC 20140318   

A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.                                

CTMT212X2102

A Phase I, Open-Label Study to Determine the Effect of Repeat Dosing of Trametinib on the Pharmacokinetics of a Combined Oral Contraceptive (Norethindrone plus Ethinyl Estradiol) in Female Patients with Solid Tumors.  This drug-drug interaction (DDI) study is being conducted to determine if there is a pharmacokinetic (PK) interaction between trametinib and the components of combination oral contraceptives (OCs), norethindrone (NE) and ethinyl estradiol (EE). Since a potential DDI that would lower the systemic concentrations of either NE or EE could lead to reduced contraceptive efficacy, it is appropriate to conduct this DDI study with trametinib.

BAY 94-9343 / 15834

Phase 1b multi-indication study of anetumab ravtansine (BAY 94-9343) in patients with mesothelin expressing advanced or recurrent malignancies. BAY 94-9343 as monotherapy in non-small cell adenocarcinoma of the lung (NSCLC adenocarcinoma), adenocarcinoma of the breast – triple negative (TNBC), gastric adenocarcinoma including gastroesophageal junction (GEJ) cancer and thymic carcinoma. BAY 94-9343 in combination with cisplatin in cholangiocarcinoma or with gemcitabine in pancreatic adenocarcinoma.  Note: Cohorts NSCLC, TNBC, Gastric/GEJ and Thymic are open.

CA209-577

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer.

ARRAY-818-302 (BEACON CRC)

A multicenter, Randomized, Open-label, 3-Arm Phase3 Study of Encorafenib + Cetuximab Plus or Minus Benimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab with a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E-mutant Metastatic Colorectal Cancer.

CP-MGAH22-04 (Sophia)

A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs. Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Two Prior Anti-HER2 Therapies and Require Systemic Treatment.

EORTC-1401-BCG

Management of low grade ductal carcinoma in situ (low-grade DCIS): a randomized, multicenter, non-inferiority trial, between standard therapy approach versus active surveillance.

STEM (EVG001BC)

A Multicentre Phase 2 Study of SFX-01 Treatment and Evaluation in Patients with Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant.

NEMO/EORTC 08112

Nintedanib as maintenance treatment of malignant pleural mesothelioma (NEMO): a double-blind randomized phase II study of the EORTC Lung Cancer Group.

DENIM

The DENIM study, an academic study sponsored by the European Union, is an open-label, randomized Phase II/III study in adult subjects with pleural mesothelioma. Patients who have stable disease after 4-6 cycles of first line Platinum/Pemetrexed chemotherapy are randomized in a 1:1 ratio to standard follow up (best supportive care) versus intervention with 3-5 intradermal and intravenous injection with a vaccine developed by Erasmus MC - Rotterdam (on top of best supportive care). For the preparation of this vaccine, autologous monocytes - received through leukapheresis- are cultured in vitro to dendritic cells that are afterwards loaded with an allogeneic lysate of mesothelioma cells. Phase 1 and 2 studies are very promising and the toxicity of the vaccine is low.  Patients are followed up by CT scan and immunologic biomarkers until disease progression. The scientists hope to see improvement of both overall and progression free survival by immunomodulation of the minimal residual disease after chemotherapy.
In order to keep the run-through-time as short as possible, patients can already be signed up for this study during their induction chemotherapy.

Our Phase I – Early Clinical Trials Unit is also working within a  Molecular Tumor Board, evaluating NGS in tissue and liquid biopsies results in order to personalize the treatment of our patients.

Open study    Study to be opened

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Open study    Study to be opened

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Open study    Study to be opened

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Open study    Study to be opened

Colorectal

Carcinoid and NET

Upper Gastointestinal

Hepatic-Biliary-Pancreatic

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Open study    Study to be opened

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Open study    Study to be opened

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Open study    Study to be opened

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Open study    Study to be opened

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Open study    Study to be opened

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Open study    Study to be opened

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Open study    Study to be opened

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