Search for a trial

Neo-adjuvant nivolumab or nivolumab with ipilimumab in advanced cutaneous squamous cell carcinoma patients prior to standard of care surgery; the MATISSE trial

Herewith, we present a research protocol for a phase II trial that allows us to examine the efficacy (histopathological response rate) of ICI in the form of nivolumab or nivolumab plus ipilimumab prior to SOC in patients with resectable stage III-…

A PHASE I/II, MULTICENTER, OPEN-LABEL, MULTI-ARM STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ACTIVITY OF IDASANUTLIN IN COMBINATION WITH EITHER CHEMOTHERAPY OR VENETOCLAX IN THE TREATMENT OF PEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE LEUKEMIAS OR SOLID TUMORS.

This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…

B-Fine: An open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in patients with Chronic Hepatitis B via intrahepatic immunophenotyping

Primary objective:To assess the effect of 12 weeks of GSK3228836 on serum hepatitis B virus surface antigen (HBsAg) levels in participants with CHBSecondaryEfficacy: To assess sustainability of serum HBsAg loss by GSK3228836 for up to 24 weeks off-…

A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis

To evaluate the efficacy based on the histological response

A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-3773274 in adults with symptomatic hypertrophic cardiomyopathy

Primary objectives:To determine the safety and tolerability of CK-3773274 in patients with symptomatic HCMSecondary objectives:- To describe the concentration-response relationship of CK-3773274 on the resting and post-Valsalva LVOT-G on…

CV019-010: A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure

The purpose of this study is to evaluate the effectiveness of the BMS-986259 study drug on blood pressure events in stable participants diagnosed with heart failure admitted to the hospital with Acute Decompensated Heart Failure (ADHF).

Guided by light: Optimizing surgical excision of oral cancer using real-time fluorescence imaging

This study has been transitioned to CTIS with ID 2024-512824-13-01 check the CTIS register for the current data. The overarching goal of this study is to improve adequate resection of oral cancer. We will perform a clinical trial to determine the…

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease

The scientific rationale for the study is summarized above and further detailed in Section 3 and the Investigator Brochure (IB). This Phase 2 randomized, double-blind clinical trial is designed to assess the safety and efficacy of BMS-986165 in…

An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn*s disease who have completed previous spesolimab trials.

1. To evaluate the long-term safety of spesolimab in patients with fistulising Crohn*s disease who have completed treatment in previous trials.2. To evaluate the long-term efficacy of spesolimab in patients with fistulising Crohn*s disease who have…

An Open Label, Phase 1/2a Trial to Evaluate the Efficacy, Safety, and Tolerability of KU002 Given as Intravesical Instillations in Subjects with Interstitial Cystitis (IC)/Bladder Pain Syndrome (BPS)*

Primary Objective:The primary objective of this study is to evaluate the safety, tolerability and PK profile following intravesical administration of KU002 in subjects with a diagnosis of BPS/IC.Secondary Objective(s):The secondary objective of the…

A Phase II, randomized, multi-center, placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud*s phenomenon (RP) and peripheral vascular blood flow, in subjects with systemic sclerosis (SSc)

Primary:To determine the safety and efficacy of GS-248 versus placebo on RP in subjects with SSc.Secondary:To determine the efficacy of GS-248 on peripheral vascular blood flow in subjects with SSc and RP.Exploratory:• To explore the…

A Randomized, Open-Label Phase 1b/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor.

The primary objective of the study is to evaluate the progression free survival of patients when these are treated with ramucirumab and cyclophosphamide and vinorelbine, in comparison to treatment without ramucirumab.The secondary objectives of the…

FaR-RMS - An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma

This study has been transitioned to CTIS with ID 2024-510579-40-00 check the CTIS register for the current data. PRIMARY OBJECTIVES*Phase 1 Dose Finding Studies:-To determine the recommended phase II dose (RP2D) of new systemic therapy regimens. *…

18F-Prostate Specific Membrane Antigen PET-CT as a potential novel imaging modality for pancreatic cancer: A pilot study (PANSCAN-2)

To investigate the feasibility of using 18F-PSMA PET-CT as a tumor-specific molecular imaging in PC, thus allowing for improved detection, therapy selection, and therapy response assessment.

A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) (a GalNAc-conjugated Small Interfering RNA [siRNA]) in Subjects with Elevated Lipoprotein(a)

Primary Objective: • To evaluate the effect of Olpasiran administered subcutaneous (SC) once every 12 weeks (Q12W) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]) after 36 weeks of treatment. Secondary Objectives: •…

REtreatment with VEnetoclax and Acalabrutinib after venetoclax Limited duration (REVEAL)
A prospective, multicenter, phase-II trial of venetoclax plus acalabrutinib in patients who have relapsed after first line venetoclax + anti-CD20 mAb treatment for chronic lymphocytic leukemia (CLL or SLL)

This study has been transitioned to CTIS with ID 2023-505449-18-00 check the CTIS register for the current data. Primary objective• To evaluate efficacy of acalabrutinib/venetoclax (AV) in terms of undetectable minimal residual disease (uMRD)…

COUNTER-COVID - Oral imatinib to prevent pulmonary vascular leak in Covid19 * a randomized, double-blind, placebo controlled, clinical trial in patients with severe Covid19 disease

To test whether treatment with oral imatinib reduce disease burden and consumption of medical resources.

A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

To evaluate the long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection with Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP)

Primary Objective• To evaluate the effect of EDP-938 on the progression of RSV infection by assessment of clinical symptomsSecondary Objectives• To evaluate the antiviral efficacy of EDP-938• To evaluate the pharmacokinetics (PK) of EDP-938• To…

A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults with Relapsed or Refractory Osteosarcoma (OLIE)

Primary ObjectiveTo evaluate whether lenvatinib in combination with ifosfamide and etoposide (Arm A) is superior to ifosfamide and etoposide (Arm B) in improving progression-free survival (PFS) by independent imaging review [IIR] using Response…