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Ongoing clinical trials

Phase 1

Sunrise (Principal investigator: prof. dr. H.M.W. Verheul)
A phase I study of high-dose, intermittent sunitinib in patients with solid tumors.

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VEGF vaccination (Principal investigator: prof. dr. H.M.W. Verheul / dr. J.J. van der Vliet)
A phase I open-label clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced solid tumors.

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NAPOLY (Principal Investigator: dr. C.W. Menke-van der Houven van Oordt)
A Phase I Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of CriPec® docetaxel in Patients with Solid Tumours.

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MACIST (Principal Investigator: dr. M. van Linde)
Phase Ib study of Metformin and Chloroquine in IDH1/2-mutated Solid Tumors (MACIST).

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MedImmune MEDI0562 (Principal Investigator: dr. J. Voortman)
A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination with Immune Therapeutic Agents in Adult Subjects with Advanced Solid Tumors.

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D6014C00005 FE (Principal Investigator: dr. M. Labots)
A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of AZD1775 After Oral Dosing of a Capsule Formulation in Patients with Advanced Solid Tumours.

D6014C00007 CA (Principal Investigator: dr. M. Labots)
An Open-Label, Non-randomised, Multicentre study to allow continued access to AZD1775 for patients enrolled in AZD1775 Clinical Pharmacology studies protocols.

BAY 94-9343_18329 (Principal Investigator: prof. dr. H.M.W. Verheul / dr. M. Labots)
An open-label, Phase I study to assess the effect of itraconazole (CYP3A4 and P-gp inhibitor) on the pharmacokinetics of anetumab ravtansine and to assess the ECG effects, safety and immunogenicity of anetumab ravtansine given as a single agent and together with itraconazole in subjects with mesothelin-expressing advanced solid cancers.

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Brain tumors

Biodistribution of temozolomide (Principal Investigator: dr. M. van Linde)
The effect of dexamethasone on the biodistribution of [3-N-11C-methyl]temozolomide in glioblastoma multiforme patients.

HGG-TCP (Principal Investigator: dr. M. van Linde)
Pilot study on the determination of tumor concentrations of protein kinase inhibitors in patients with newly diagnosed high-grade glioma.  

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ROAR (BRF117019) (Principal Investigator: dr. M. van Linde)
A Phase II, Open-label, Study in Subjects with BRAF V600EMutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib.

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M13-813 (Principal Investigator: dr. M. van Linde)
A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth factor Receptor (EGFR) Amplification.

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MACIST (Principal Investigator: dr. M. van Linde)
Phase Ib study of Metformin and Chloroquine in IDH1/2-mutated Solid Tumors (MACIST).

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Head and neck cancer

EORTC-1206-HNCG (Principal Investigator: dr. J. Buter)
A randomized phase II study to evaluate the efficacy and safety of chemotherpay (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs).

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Checkmate 714 (CA209-714) (Principal Investigator: dr. J. Buter)
A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in Combination with Ipilimumab Placebo In Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).

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MK3475-412 (Principal Investigator: dr. J. Buter)
A Randomized Phase III study of pembrolizumab given concomitantly to chemoradiation and as maintenance therapy versus chemoradiation alone in patients with locally advanced squamous cell carcinoma of the head and neck.

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Breast cancer 

IMPACT Breast (Principal Investigator: dr. C.W. Menke-van der Houven van Oordt)
Towards patient tailored cancer treatment supported by molecular imaging - IMPACT: IMaging PAtients for Cancer drug selecTion - Metastatic Breast Cancer.

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PALM (Principal Investigator: L. Buffart)
Physical Activity Levels in patients with Mammacarcinoma (PALM) study

SUBITO (Principal Investigator: dr. I.R.H.M. Konings)
Substantially improving the cure rate of highrisk BRCA1-like breast cancer patients with personalized therapy (SUBITO) an international randomized phase III trial.    

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SONIA trial (Principal Investigator: dr. I.R.H.M. Konings)
Selecting the Optimal PositioN of CDK4/6 Inhibitors in HR+ Advanced Breast Cancer: the SONIA trial.

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AIPAC (Principal Investigator: dr. C.W. Menke-van der Houven van Oordt)
A multicentre, phase IIb, randomised, double blind, placebo-controlled study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3lg fusion protein) or placebo as adjunctive to a standard chemotherapy treatment regimen of paclitaxel.

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Tumors of the colon and rectum

ORCHESTRA (Principal Investigator: prof. dr. H.M.W. Verheul)
A randomized multicenter clinical trial for patients with multi-ORgan, Colorectal cancer metastases comparing the combination of cHEmotherapy and maximal tumor debulking versuS chemoTheRapy Alone: ORCHESTRA.

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CAIRO 4 (Principal Investigator: prof. dr. H.M.W. Verheul)
The role of surgery of the primary tumour with few or -absent symptoms in patients with synchronous unresectable metastases of colon cancer,a randomized phase III study.

COLONUT (Principal Investigator: Dr. M.A.E van Bokhorst- de van der Schueren and Prof. dr. H.M.W. Verheul)
The effect of individualized nutritional counselling on muscle mass and treatment outcome in patients with metastatic colorectal cancer undergoing chemotherapy. 

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IMPACT CRC (Principal Investigator: prof. dr. H.M.W. Verheul)
Image guided treatment optimalization with cetuximab for patients with metastatic colorectal cancer: IMPACT - CRC.

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Corsica (Principal Investigator: prof. dr. H.M.W. Verheul)
A fase I study of SGI-110 Combined with irinotecan followed by a Randomized phase II study of SGI-110 combined with irinotecan versus regorafenib in previously treated metastatic colorectal cancer patients.

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METRIC study (Co-Investigator: prof. dr. H.M.W. Verheul)
MEchanisms of TRaining In patients with Cancer (METRIC) study.  

CAIRO 5  (Principal Investigator: prof. dr. H.M.W. Verheul)
Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases: CAIRO5, a randomised phase 3 study of the Dutch Colorectal Cancer Group (DCCG).

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GemDoc (Principal Investigator: prof. dr. H.M.W. Verheul)
A multi-institutional open label, trial evaluating the efficacy of Gemcitabine and Docetaxel in patients with relapsed or refractory metastatic colorectal adenocarcinoma with methylated CHFR and/or microsatellite instability phenotype.

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TESAR trial (Principal Investigator: dr. J. Tuynman)
Rectal preserving treatment for early rectal cancer. A multicentred randomized trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer.

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PremAb-DOSE TRIAL (Principal Investigator: dr. M. van Egmond and dr. J. van der Vliet)
Pre-operative Administration of Anti-EFGR Monoclonal Antibodies (Cetuximab) for the Eradication of Circulating Tumor Cells in Patients Undergoing Curative Resection of Colorectal Liver Metastases; a dose finding study.

CAIRO 6 (Principal Investigator: dr. J. Tuynman)
Peri-operative systemic therapy and surgery versus surgery alone for resectable colorectal peritoneal metastases: the multicentre, phase II-III, randomised CAIRO 6 study.

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Pancreatic cancer

Currently there are no ongoing clinical trials for patients with pancreatic cancer.

Esophageal and gastric tumors

VEGF expression in EC (Principal Investigator: prof. dr. H.M.W. Verheul)
Pilot study to determine the effect of fractionated radiotherapy on expression of pro-angiogenic factors in oesofagus carcinoma

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Liver tumors

Currently there are no ongoing clinical trials for patients with liver tumors.                                                                                                                                                                                                                   

Urological tumors 

INCYTE INCB054828 (Principal Investigator: dr. J. Voortman)
A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations.

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Healthy men vs. prostate cancer patients (Principal Investigator: dr. A.J.M. van den Eertwegh)
Monitoring of DC and T cell functions in patients with prostate cancer treated with GM-CSF transduced allogeneic vaccines and anti-CTLA-4.

CAPRI (Principal Investigator: H. Westgeest)
Castration-resistant Prostate cancer RegIstry (CAPRI): an observational study in the Netherlands.

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Viable (Principal Investigator: dr. A.J.M. van den Eertwegh)
A randomized, double blind, multicenter, parallel-group, phase III study to evaluate efficacy and safety of DCVAV/PCa versus placebo in men with metastatic castration resistant prostate cancer eligible for 1st line chemotherapy.

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IMvigor010 / WO29636 (Principal Investigator: dr. J. Voortman)

A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection.

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IMPACT mRCC (Principal Investigator:  dr. C.W. Menke- van der Houven van Oordt)
Watchful waiting in patients with good and intermediate risk metastatic renal cell carcinoma; an imaging guided observational approach.

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ROTOR14 (Principal Investigator: dr. A.J.M. van den Eertwegh)
Registry of Treatment Outcomes in a non-study population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated with Radium-223 (ROTOR-registry).

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RECAB2 (Principal Investigator: dr. A.J.M. van den Eertwegh)
A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment.  

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CABAZIPET (Principal Investigator: dr. A.J.M. van den Eertwegh)
Towards early identification of response to cabazitaxel in patients with metastatic castration-resistant prostate cancer: potential of 18F-Choline PET-CT.

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GALAHAD / Niraparib (Principal Investigator: dr. A.J.M. van den Eertwegh)
A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies.

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WO39210 Atezolizumab (IMmotion010) (Principal Investigator: dr. A.J.M. van den Eertwegh)
This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

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Medimmune 2 (Principal Investigator: dr. J. Voortman)
A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination with Immune Therapeutic Agents in Adult Subjects with Advanced Solid Tumors.

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Gynaecological tumors

Currently there are no ongoing clinical trials for patients with gynaecological tumors.

Melanomas

REPOSIT (Principal investigator: dr. A.J.M. van den Eertwegh)
A Phase II, Open-Label, Multicenter Study of Vemurafenib plus Cobimetinib (GDC-0973) in Unresectable Stage IIIc or Stage IV Melanoma -Response Monitoring and Resistance Prediction with Positron Emission Tomography and Tumor Characteristics.

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Zirconipi (Principal investigator: dr. A.J.M. van den Eertwegh)
Uptake and biodistribution of 89Zirconium-labeled ipilimumab in ipilimumab treated patients with metastic melanoma.

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Masterkey-265 (Principal investigator: dr. A.J.M. van den Eertwegh)
A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected, Stage IIIB to IVM1c Melanoma.

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Various tumor types

Pilot ICK (Principal Investigator:  prof. dr. H.M.W. Verheul / drs. M. Labots)
Pilot study on the determination of intratumoral concentrations of kinase inhibitors in patients with advanced solid malignancies.

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MEDEA (Principal Investigator: Prof. dr. H.M.W. Verheul)
Metoclopramide, Dexamethasone or Aloxi for the prevention of delayed chemotherapy-induced nausea and vomiting in moderately emetogenic non-AC-based chemotherapy: the MEDEA trial.

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OptiMal-trial (Principal Investigator: Prof. dr. H.M.W. Verheul)
Optimization of systemic treatment strategies in elderly patients with advanced solid Malignancies.

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CPCT- 02 biopsy protocol (Principal Investigator: Prof. dr. H.M.W. Verheul)
Development of a platform for next-generation DNA sequencing based personalized treatment for cancer patients: Protocol to obtain biopsies from patients with locally advanced (incurable) or metastatic cancer.

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SIGN protocol (Principal Investigator: Prof. dr. H.M.W. Verheul/ Prof. dr. J. Dekker)
Supporting Resilience and Case Finding. Evaluation of an Innovative Procedure for Detecting Psychological Distress in Patients with Cancer

ROAR (BRF117019) (Principal Investigator: dr. M. van Linde)
A Phase II, Open-label, Study in Subjects with BRAF V600EMutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib.

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The DRUP trial (Principal Investigator: prof. dr. H.M.W. Verheul)
A National Study to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to determine the Potential Efficacy in Treatment of Advanced Cancers with a Known Molecular Profile.

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Counting steps (Principal Investigator: prof. dr. H.M.W. Verheul)
Counting steps in cancer patients.

Palliative care

Currently there are no ongoing clinical trials for palliative care.

Contact for patients

For more information regarding participation in a clinical trial please contact your treating physician.
Or u can mail to trialoffice-onc@vumc.nl

Referral information

For referral of patients for participation in a clinical trial please contact the Principal Investigator at tel. +31 20 444  4321.
Or u can mail to trialoffice-onc@vumc.nl

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