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Phase 1/2 dose escalation and cohort expansion study evaluating MCLA-158 (Petosemtamab) as single agent or in combination in advanced solid tumors

This study has been transitioned to CTIS with ID 2024-513627-16-01 check the CTIS register for the current data. Dose escalationPrimary• To determine the RP2D of single-agent petosemtamab in mCRC patients who have progressed on chemotherapy, with or…

Standard moderately hypofractionated radiotherapy vs. ultra-hypofractionated focal lesion ablative microboost in prostate cancer, Hypo-FLAME 3.0

To demonstrate superiority of whole gland SBRT with a simultaneous integrated focal boost 35/50 Gy in 5 fractions (Hypo-FLAME) regarding 5-year bDFS compared to the current standard moderately hypofractionated schedule of 62 Gy in 20 fractions of 3.…

Phase II study of oral metformin for intravesical treatment of non-muscle-invasive bladder cancer

The primary objective is to determine the complete response rate to administration of oral metformin Secondary objectives are: to determine the partial response rate, the overall safety of metformin, the quality of life during metformin treatment…

Phase II randomised controlled trial of patient-specific adaptive versus continuous Abiraterone or eNZalutamide in metastatic castration-resistant prostate cancer: the ANZadapt study

The primary objective is to investigate whether the patient-specific adaptive treatment with AA/ENZ leads to a superior time to time to treatment failure (TTTF) while on treatment compared to continuous treatment with AA/ENZ. Secondary/tertiary…

A phase 3, randomized, placebo-controlled, double-blind study of vimseltinib to assess the efficacy and safety in patients with tenosynovial giant cell tumor (MOTION)

This study has been transitioned to CTIS with ID 2024-513624-42-00 check the CTIS register for the current data. Primary Objective: • To evaluate anti-tumor activity of vimseltinib using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by…

A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 in Combination with Obinutuzumab (GA101) in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Indolent Non-Hodgkin*s Lymphoma

Primary Objectives:• Determine the safety and tolerability of CC-122 administered in combination with obinutuzumab.• Determine the non-tolerated dose (NTD), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of CC-122 administered in…

A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible

This study has been transitioned to CTIS with ID 2023-507632-20-00 check the CTIS register for the current data. The primary objective is to compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT,…

Demonstrating the (cost-)effectiveness of a personalized live-remote exercise intervention for cancer survivors using a super umbrella randomized controlled trial:
the LION-RCT

The primary objective of the LION RCT is to assess the (cost-)effectiveness of a personalized, live-remote exercise intervention for cancer survivors on Health-Related Quality of Life (HRQOL) and the participants* main, self-reported side-effect.…

FeelFit: high-intensity interval training to improve self-reported physical fitness in brain tumor patients: a randomized controlled trial

The primary objective is to investigate the efficacy of HIIT on self-reported physical fitness in primary brain tumor patients during stable disease. The secondary objective is to investigate the efficacy of HIIT on the maximal oxygen uptake (VO2max…

A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma

This study has been transitioned to CTIS with ID 2024-518627-29-00 check the CTIS register for the current data. PRIMARY OBJECTIVE• To compare the efficacy of Ampligen® versus control group / no treatment following FOLFIRINOX in subjects with…

A Phase I/II, Single-Arm, Open-label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged >= 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE)

Primary objectives:- To determine the PK of selumetinib after administration of the selumetinib granule formulation. - To assess the safety and tolerability of the selumetinib granule formulation.

Sarcomas and DDR-Inhibition; a neoadjuvant phase I combined modality study - SADDRIN-1

This study has been transitioned to CTIS with ID 2024-514907-32-00 check the CTIS register for the current data. To assess the safety and tolerability profile, in the pre- and perioperative period (up to 30 days post-surgery), of combined modality…

The food-effect of a standardized Dutch breakfast on the pharmacokinetics of oral alectinib (Alecensa®) using a stable isotopically labelled microtracer approach

To determine the food-effect of a standardised Dutch breakfast on the pharmacokinetics of oral alectinib (Alecensa®), especially Cmax, AUC and relative bioavailability, at steady state using a stable isotopically labelled microtracer approach.

A PHASE Ia/Ib, OPEN LABEL, MULTICENTER, DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7502175 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

This study has been transitioned to CTIS with ID 2023-504709-35-00 check the CTIS register for the current data. This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability,…

Detecting cancers Earlier Through Elective plasma-based CancerSEEK
Testing - Ascertaining Serial Cancer patients to Enable New Diagnostic
II (DETECT-ASCEND 2)

The primary objective of this study is to obtain clinically characterized, whole blood specimens from subjects with a new or suspected diagnosis of cancer (cancer subjects) and from subjects who do not have a diagnosis of cancer (healthy) to develop…

A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient- reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin receptor-positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (COMPOSE)

This study has been transitioned to CTIS with ID 2024-510812-64-00 check the CTIS register for the current data. The purpose of this study is to investigate the efficacy and safety of the investigational drug known as Lutetium (177Lu) edotreotide in…

A Phase 1a/1b Open label, Multicenter, Global, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

This study has been transitioned to CTIS with ID 2023-506285-31-00 check the CTIS register for the current data. This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 as a single agent (Phase Ia) or in…

PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE® ) IN
COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE AND/OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN
PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID
TUMORS

Primary: To compare the efficacy of palbociclib in combination with TMZ and IRN vs TMZ and IRN chemotherapy alone in the treatment of children, adolescents, and young adults with recurrent or refractory EWS.Secundary: To further compare the efficacy…

A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers

Primary• To evaluate the safety and tolerability of AMG 199 in adult subjects• To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) Secondary• To characterize the PK of AMG 199 • To evaluate preliminary anti-tumor…

Microsampling for therapeutic drug monitoring of imatinib, dasatinib, nilotinib, gilteritinib, midostaurin, and venetoclax

The primary objective is to perform a clinical validation of dried blood spot microsampling of imatinib, dasatinib, nilotinib, gilteritinib, midostaurin, and venetoclax. The secondary objective is to test the feasibility of home monitoring (…