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Phase II, Open-label, Study in Subjects with BRAF V600E - Mutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib (BRF117019)

Primary: efficacy of dabrafenib and trametinib combination therapy compared to placebo with respect to overall response rate in subjects with rare BRAF V600E mutated solid tumors or hematologic malignancies.Secondary: duration of response,…

Intraoperative near-infrared fluorescence imaging of colorectal carcinoma with cRGD-ZW800-1 and dedicated imaging systems: A Phase II study

To assess the feasibility of cRGD-ZW800-1 to visualize tumors in real-time using dedicated NIR fluorescence imaging systems

An open label Phase I Positron Emission Tomography Imaging study to investigate the bio-distribution and tumor uptake of [89Zr]Zr-BI 905677 in patients with advanced tumors harbouring an RNF43 mutation or R-Spondin Fusion

BI 905677 is a drug being developed for the treatment of cancer. The main purpose of this study is to investigate how the study drug BI 905677 spreads in the body and in the tumor. This is examined using a technique called Positron emission…

Study of expression of and immunity against neoantigens in patients with constitutional mismatch repair deficiency (CMMR-D) syndrome

In this explorative study, we aim to:• Analyze neoantigens expressed on different tumors of CMMR-D patients, to identify possible target antigens for DC vaccination studies.• Investigate the presence of pre-existing immune responses against…

Microdosing as a tool to individualize docetaxel dosing: development of a limited sampling model

The primary objective of this study is to establish the relationship between microdose and therapeutic dose docetaxel pharmacokinetics. Our secondary objective is to develop a limited sampling model of microdose docetaxel pharmacokinetics to predict…

Pan Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab

Primary:Long-term safety of nivolumab in participants on treatment and in follow upExploratory:To follow participants who have completed therapy and are in or have completed follow-up on a parent study investigating nivolumab or nivolumab…

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…

Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy (ADMIRE) for head and neck cancer by twice re-imaging, re-delineation and re-planning during the course of radiotherapy

Primary objective: To investigate the feasibility of the adaptive radiotherapy scheme.Secundary objectives:To examine the toxicity of the adaptive RT schemeTo investigate the locoregional tumor controlTo examine the prognostic value of the different…

Observational study to evaluate pharmacokinetics and pharmacodynamics of docetaxel, paclitaxel, doxorubicin, gemcitabine, vinorelbine, and capecitabine in elderly patients.

Primary objective To determine the relation between age and pharmacokinetics of docetaxel, paclitaxel, doxorubicin, gemcitabine, vinorelbine and capecitabine, respectively. Secondary objectives All here cited secondary endpoints will be separately…

A phase I open-label clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced solid tumors

Primary objectives- To investigate the safety and tolerability profile of hVEGF26-104/RFASE.- To determine the effective dose of hVEGF26-104/RFASE required to neutralize VEGF in serum, defined as a VEGF level below 9,0 pg/mL.Secondary objectives- To…

Open label multicenter Phase I/II study of the safety and efficacy of PDR001 administered to patients with advanced malignancies (CPDR001X2101)

Primary: Phase 1: To estimate the RP2D and/or the MTD for PDR001.Phase II: To estimate the anti-tumor activity of PDR001.Secondary: Both phases: Safety and tolerability, PK profile, emergence of anti-PDR001 antibodies, other parameters for…

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).…

A phase I study to investigate the safety of TEG001 cell suspension for infusion in patients with relapsed/refractory Acute Myeloid Leukemia/high-risk Myelodysplastic Syndrome (IPSS-R score >4,5) relapsed/refractory or Multiple Myeloma

This study has been transitioned to CTIS with ID 2024-517381-42-00 check the CTIS register for the current data. This study aims to assess the safety of TEG001. Furthermore, the feasibility of TEG001 production with material from intensively pre-…

Vincristine-induced peripheral neuropathy in children with childhood cancer: comparing one-hour infusions with short-term infusions (the VINCA-study)

This study aims to investigate whether the administration of VCR in children with acute lymphoblastic leukemia, nephroblastoma, low-grade glioma, Hodgkin lymphoma and rhabdomyosarcoma by one-hour infusions, resulting in lower peak plasma…

INTERNATIONAL COLLABORATIVE TREATMENT PROTOCOL FOR
CHILDREN AND ADOLESCENTS WITH LANGERHANS CELL HISTIOCYTOSIS

This study has been transitioned to CTIS with ID 2024-512676-36-00 check the CTIS register for the current data. * To decrease mortality in MS-LCH by an early switch of patients with risk organ involvement, who do not respond to front-line therapy,…

A Randomized Phase III study of pembrolizumab given concomitantly with chemoradiation and as maintenance therapy versus chemoradiation alone in subjects with locally advanced head and neck squamous cell carcinoma (KEYNOTE-412)

Primary: To compare Event-free survival (EFS) per RECIST in subjects treated with pembrolizumab in combination with CRT and subjects treated with placebo in combination with CRT.Secondary:(1) To compare Overall Survival (OS) in subjects treated with…

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…

A phase I/II study evaluating the safety and activity of Pegylated recombinant human Arginase (BCT-100) in Relapsed/refractory cancers of Children and young adults

Primary:* Phase I: to establish the recommended phase II dose (RP2D) of BCT-100 in children andyoung adults as assessed by dose limiting toxicity (DLT) and complete arginine depletion.* Phase II: to determine the activity of single agent BCT-100…

A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies

Primary objectives:* Part 1: To evaluate the safety and tolerability and determine the recommended dose(s) of INCB059872 for further study in advancedmalignancies.* Part 2: To further evaluate the safety and tolerability of INCB059872 for further…

A modular, multi-arm, multi-part, first time in patient study to evaluate the
safety and tolerability of OMO-1, alone and in combination with anti-cancer
treatments, in patients with locally advanced, unresectable or metastatic
solid malignancies

Core:Core Primary Objective:* To investigate the safety and tolerability of OMO-1 when given orally to patients with locally advanced, unresectable or metastatic solid malignancies, alone or in combination with anti-cancer treatments, and define the…