Villeneuve St Georges Cedex, France
- Featured
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)
For more information, please contact Incyte Corporation at 1.855.463.3463 or visit **[www.incyteclinicaltrials.com](https://www.incyteclinicaltrials.com/)**
Phase
3Span
Sponsor
Vandoeuvre-Les-Nancy, Meurthe-et-Moselle
Recruiting
- Featured
TemPo Studies
**All eligible study participants will receive at no cost:** • Study-related consultation and care • Study visits, tests, assessments, and procedures • Study drugs (investigational drug or placebo)
Phase
N/ASpan
212 weeksSponsor
Cerevel TherapeuticsNancy, France
Recruiting
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Phase
3Span
242 weeksSponsor
Janssen-Cilag Ltd.Vandoeuvre-les-Nancy
Recruiting
Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR
Phase
2/3Span
892 weeksSponsor
University Hospital, AngersVandoeuvre-les-Nancy
Recruiting
French Childhood Cancer Survivor Study
The main objectives of the FCCSS are to: - estimate the relationship between doses received (radiotherapy, chemotherapy) at a given organ and risk of second malignancy tumors; - help identify patients at higher risk; - compare the mortality occurred among the survivors with the general population; - investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (such as cardiovascular, cerebrovascular and thyroid diseases, diabetes,…); - characterize survivors with respect to socioeconomic status and quality of life. The cohort will be ascertained using: - the medical records from the treatment centers in order to characterize the childhood cancer, estimate doses of radiotherapy received by all organs and measure the chemotherapy administered; - the French National Identification Registry and the French Death Registry in order to obtain the vital status and the causes of the deaths for the former patients - a self-questionnaire that covers the entire future of the survivors (e.g. social status, family network, fertile offspring, access to care, access to bank loans, occupation,...); - the French National Health Insurance Information System that contains data on all reimbursements for health expenditure including medicinal products as well as outpatient medical and nursing care, prescribed or performed by healthcare professionals. In an initial cohort, we have already studied the iatrogenic effects of the cancer treatments. We have estimated the doses of ionising radiations delivered by radiotherapy to the target volume and by organs at distance. We found an important role of the radiotherapy and chemotherapy in the risk of a second cancer: - the cancers occuring after childhood cancer are in excess compared to the general population, - we studied the relationship between the brain radiation dose and the cerebrovascular mortality, - there is a high risk of cardiac pathology after anthracyclines administration for a childhood cancer, - cancer treatments increase the risk of second malignant neoplasms in digestive organs after a very long latency period, - the risk of thyroid adenoma increased with the radiation dose received by the thyroid during childhood cancer treatment, and plateaued at high doses, - there is a high long-term mortality risk for all types of second malignant neoplasms whatever the treatment received.
Phase
N/ASpan
1048 weeksSponsor
Institut National de la Santé Et de la Recherche Médicale, FranceVandoeuvre-les-Nancy
Recruiting
Perioperative Dynamics of Energy Expenditure in Oesophagectomy Patients
The results of this study should enable current nutrition protocols to evolve and nutritional support to be incorporated into a more global project of individualised perioperative medicine.
Phase
N/ASpan
174 weeksSponsor
University Hospital, RouenVandoeuvre-les-Nancy
Recruiting
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France
Included patients will be followed until the end of study, death or lost to follow-up even if ribociclib and ET are discontinued. The end of the study is defined as 3 years after the first visit of the last patient included (Last Patient First Visit [LPFV]). The total duration of the study will be 4 years and half (18 months of inclusion + 3 years of follow-up). Thus, a patient included at the beginning of the inclusion period will be followed for 4 years and half and a patient included at the end of the inclusion period will be followed for at least 3 years.
Phase
N/ASpan
290 weeksSponsor
Novartis PharmaceuticalsVandoeuvre-les-Nancy
Recruiting
CARE1 Pragmatic Clinical Trial
In 2020, there were an estimated 431 288 new cases of kidney cancer (Renal Cell Carcinoma, RCC) globally with 138 611 cases in Europe, leading to 179 368 deaths worldwide, including 54 054 deaths in Europe (source: IARC/Globocan). To define high priority topics in academic research and launch dedicated trials, European RCC academic physicians have gathered into a European initiative - the CARE group. Systemic therapy for RCC relies on two classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD-1/PD-L1 axis or CTLA-4. Combination therapy is standard of care (SOC) for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI. However, no head-to-head comparison have been performed between the two approaches and patients are treated based on physician decision without clinical or biomarker factors to guide treatment selection. PD-L1 staining is, to date, the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PD-L1(+) and ICI-VEGFR TKI in PD-L1(-) patients. CARE1 PCT is a prospective randomize phase III study, in first line setting for patients with metastatic clear cell RCC comparing ICI-ICI vs ICI-VEGFR TKI approaches stratified on PD-L1 by local determination. Primary endpoint is overall survival (OS). The trial will enroll 1250 patients over 4 years across eight European countries (France, Spain, Netherlands, Czech Republic, Austria, Germany, Italy, UK) that are part of the CARE consortium. Study Sponsor is Gustave Roussy institute within the GETUG network for France, co-sponsor is developed through main academic networks (eg. SOGUG in Spain) and main institutions across Europe (eg. Cancer Core Europe - CCE). Study design has been develop to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging OS for PD-L1(+) patients and that ICI-VEGFR TKI is superior to ICI-ICI in prolonging OS for PD-L1(-) patients. CARE1 PCT has been designed and will be conducted with patient advocacy group representatives (ARTuR and IKCC) input. CARE1 is an academic phase III study designed to define the optimal combination using a pragmatic routinely implementable biomarker. Therefore, CARE1 will inform practice and has the potential to change treatment guidelines. Taken all together, CARE1 is a unique opportunity to build a large-scale platform to define new biomarker based therapy guidelines as well as to investigate quality of life, patient reported outcome and Health-Economic in front line setting, as well as pathological and blood biobank collection for further translational work. This action is part of the Cancer Mission cluster of projects on 'Diagnosis and treatment'.
Phase
3Span
421 weeksSponsor
Gustave Roussy, Cancer Campus, Grand ParisVandoeuvre-les-Nancy
Recruiting
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
Phase
2Span
175 weeksSponsor
Eli Lilly and CompanyVandoeuvre-les-Nancy
Recruiting
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 2 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Maintenance Extension.
Phase
2Span
222 weeksSponsor
Morphic Therapeutic, IncVandoeuvre-les-Nancy
Recruiting