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Intra-operative evaluation of a novel FLUorescENt C-mEt tracer in penile and tongue cancer

This study has been transitioned to CTIS with ID 2024-518046-25-00 check the CTIS register for the current data. Evaluation of the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.

Long-Term Follow-Up (LTFU) of Participants Treated with Adoptive Cell Therapies (study 208750)

This study has been transitioned to CTIS with ID 2024-513033-21-00 check the CTIS register for the current data. Primary:• To monitor participants for delayed AEs associated with administration of autologous cells that have been genetically modified…

A Phase 1 first- in-human dose escalation and expansion study for the evaluation of safety,
pharmacokinetics, pharmacodynamics and anti-tumor activity of SAR441000 administered intratumorally as monotherapy and in combination with cemiplimab in patients with advanced solid tumors

Primary Objectives: Dose Escalation (SAR441000 Monotherapy): -To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the overall safety and tolerability profile of SAR441000 when administered intratumorally as…

The AIM-HN and SEQ-HN Study: A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)

Primary Objective: • To determine the objective response rate (ORR) of tipifarnib in subjects with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS mutations with a VAF>=20% (High VAF population), as assessed by Independent Review…

Motivational coaching to improve physical activity behaviour following a supervised 10-week exercise rehabilitation program in cancer patients

The main objective of this study is to examine the effect of motivational coaching following oncological rehabilitation in cancer patients, on minutes of moderate- to- vigorous physical activity (MVPA) measured after six months, with an…

Ultrasound guided resection of tongue and buccal mucosa cancer

In last decades, ultrasound probes have become smaller, which made adequate intraoral ultrasound of oral tumors possible. Therefore, invasion depth is now determined pre-operatively by intraoral ultrasound for staging of oral cancer. Our feasibility…

INFORM2 exploratory multinational phase I/II combination study of Nivolumab and Entinostat in children and adolescents with refractory high-risk malignancies

This study has been transitioned to CTIS with ID 2024-514409-78-01 check the CTIS register for the current data. Primary objectivePhase I (Phase I of the younger cohort was concluded in May 2023): To determine the recommended phase II dose (RP2D) of…

A PHASE II, RANDOMIZED, ACTIVE-CONTROLLED, MULTI-CENTER STUDY COMPARING THE EFFICACY AND SAFETY OF TARGETED THERAPY OR CANCER IMMUNOTHERAPY GUIDED BY GENOMIC PROFILING VERSUS PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH CANCER OF UNKNOWN PRIMARY SITE WHO HAVE RECEIVED THREE CYCLES OF PLATINUM DOUBLET CHEMOTHERAPY

Study MX39795 will compare the efficacy and safety of molecularly-guided therapy versusstandard platinum-containing chemotherapy in patients with poor prognosis cancer of unknown primary site(CUP; non-specific subset) who have achieved disease…

A Phase I/IIa open-label, multi-center study to evaluate the safety, tolerability, whole-body distribution, radiation dosimetry and anti-tumor activity of [177Lu]-NeoB administered in patients with advanced solid tumors known to overexpress gastrin-releasing peptide receptor (GRPR)

This study has been transitioned to CTIS with ID 2023-507170-41-00 check the CTIS register for the current data. Primary:Phase I: • To identify the maximum tolerated dose (MTD) and/or Recommended Phase II dose (RP2D) of [177Lu]-NeoB Phase IIa:•…

A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001)

Primary Objectives:• To characterize the safety and tolerability and to identify the recommended Phase 2 dose (RP2D) of ALKS 4230 administered subcutaneously (SC) as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced…

Urimon, study of blood and urine for health monitoring

The goals of the Urimon study is to test the hypothesis that microRNA expression profiles in periodic urine- and blood samples from individuals can be used for the sensitive detection of the onset of disease.

ADJUSTment Disorder in Cancer Patients: Effectiveness and Cost-Utility of Tailored Psychological Treatment

The ultimate aim of this project is to provide scientific evidence on tailored psychological interventions for cancer patients with an adjustment disorder. This study investigated the effectiveness, cost-utility and budget impact of a tailored…

Phase I/II pharmacokinetic multi-tumor study of subcutaneous formulation of nivolumab monotherapy

This study has been transitioned to CTIS with ID 2023-503554-12-00 check the CTIS register for the current data. The primary objective of the study is to describe the pharmacokinetics of Nivolumab (how quickly it is absorbed by the body) when…

Mapping of Sentinel lymph node drainage Using SPECT/CT to tailor highly selective elective nodal irradiation in node-negative neck of patients with head and neck cancer - SUSPECT-2

To prospectively evaluate the oncologic safety of selective SPECT/CT-guided ENI in a larger cohort of HNSCC patients

A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects with Advanced Solid Tumours.

Principal objectives: •To determine the safety, tolerability and recommended dose of FP- 1305 in subjects withadvanced solid tumours of the selected tumourtypes without standard treatment options.• To determine the safety, tolerability and early…

PHARMACOKINETICS OF APREPITANT, DEXAMETHASONE AND THEIR INTERACTION IN CHILDREN WITH CHEMOTHERAPY INDUCED NAUSEA AND VOMITING: A PILOT STUDY

we propose a pilot PK study to assess: 1) The interaction between aprepitant and dexamethasone in children using both antiemetogenic agents at the same time, to optimize the dose of both agents in children of different age groups.2) The feasibility…

Safety and tolerability of neoadjuvant nivolumab for locally advanced resectable oral cancer, combined with [18F]BMS-986192 / [18F]-FDG PET imaging and immunomonitoring for response prediction.

1) To assess uptake of [18F]BMS-986192 in tumor lesions before and after treatment with nivolumab, in relation to [18F]-FDG uptake as potential whole body biomarker for response. 2) To evaluate safety and tolerability of neoadjuvant nivolumab 3) To…

Imaging of tumour microenvironment in patients with oropharyngeal head and neck squamous cell carcinoma using RGD PET/CT imaging.

The aim of this study is to assess differences in tumour microenvironment between HPV+ and HPV- oropharyngeal HNSCC using [68Ga]Ga-RGD2 PET/CT and perfusion CT.

A Phase 2, Open-Label, multi-center Study of AL101 in patients with adenoid cystic carcinoma (ACC) bearing activating Notch mutations

Primary objective:To assess the clinical activity of AL101 using radiographic assessments and RECIST v1.1 in ACC patients with activating Notchmutations.Secundary objectives:• To assess quality of life in ACC patients with activating mutations.• To…

Exploratory study on nasal high flow therapy for breath hold in radiotherapy (ENTheR-study)

The objective of this study is to investigate the feasibility of treating breast and lung cancerpatients in mDIBH using nasal a high-flow therapy (NHFT) device.