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A phase II, open label study to investigate the efficacy and safety of domatinostat in combination with avelumab in patients with advanced unresectable/metastatic Merkel Cell Carcinoma progressing on anti-PD(L)1 antibody therapy - the MERKLIN 2 study

Objectives:Primary Objective: to investigate the anti-tumor efficacy of domatinostat in combination with avelumab in advanced unresectable/metastatic MCC patients progressing on anti-PD-(L)1 antibody monotherapy.Secondary Objectives: to investigate…

Neo-adjuvant T-VEC + Nivolumab combination therapy for resectable early metastatic (stage IIIB/C/D-IV M1a) melanoma with injectable disease.

Primary objective:- To investigate if neo-adjuvant combination of talimogene laherparepvec and nivolumab will achieve a pathologic response rate of 45% complete responses (either *pathological complete response (pCR)* or *pathological near complete…

A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination with Durvalumab and in Combination with Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC).

ObjectivesPrimary* To determine the efficacy (as assessed by radiographic progression free survival [rPFS]) of AZD4635 plus durvalumab and separately of AZD4635 plus durvalumab plus cabazitaxel in participants with mCRPC.Secondary* To evaluate the…

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to
Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with
Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or
Branebrutinib Treatment Followed by Open-label Abatacept Treatment in
Subjects with Active Rheumatoid Arthritis.

pSS: • To compare the efficacy of branebrutinib with PBO at Week 24 in the treatment of subjects with pSS• To compare the safety and tolerability of branebrutinib with PBO in subjects with pSSRA: • To compare the efficacy of branebrutinib with PBO…

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-…

Tiratricol treatment of children with Monocarboxylate Transporter 8 deficiency: Triac Trial II

This study has been transitioned to CTIS with ID 2024-516123-13-00 check the CTIS register for the current data. Part I:Primary Objective: Evaluate the effects of tiratricol on neurodevelopment in young MCT8 deficiency patients, as measured by the…

A PHASE 2 STUDY OF FUTIBATINIB IN PATIENTS WITH SPECIFIC FGFR ABERRATIONS

Cohorts A nd B :The primary objective is to evaluate the objective response rate (ORR) in patients with solid tumors harboring FGFRrearrangements or gastric cancer (including GEJ cancer) harboring FGFR2 amplifications based on independent central…

An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475
(Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin
Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE
667).

This study has been transitioned to CTIS with ID 2023-504821-38-00 check the CTIS register for the current data. Goal of this study is to determine the optimal balance between maintaining high rates of OS in this group and avoiding the long-term…

First line treatment with VeNEtoclaX and ibruTinib induction followed by obinutuzumab intenSificaTion Exclusively in CLL/SLL Patients not in complete remission and/or with detectable bone marrow minimal residual disease (NEXT STEP trial)

Primary objective- To evaluate the efficacy of 6 cycles ibrutinib/obinutuzumab in converting patients who are not in CR or who have detectable MRD on combination ibrutinib and venetoclax in uMRD (BM) CR Secondary objectives- To explore the kinetics…

EMDR Flash Forward as an intervention on the mental images of worst case scenarios in paranoid delusions

Primary Objective: Investigate whether EMDR Flash Forward is an effective intervention to process the mental images of worst case scenarios that occur in paranoid delusions, in order to decreases the preoccupation with the delusion.Secondary…

Prospective registration study on the sentinel node procedure for bulky squamous cell carcinoma of the nasal vestibule

To prospectively document the introduction of the sentinel node procedure for bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal involvement.

Rescue by radiotherapy and anti-CTLA4/PD-1 after failure of anti-PD-1 therapy in metastatic NSCLC patients, a proof-of-concept study.

Primary objectives:• to assess the safety of combining nivolumab, ipilimumab and up to 3 fractions of medium dose hypofractionated radiotherapy (mRT) to multiple tumor sites (1 to 4, with at least 1 site receiving 24Gy)• to explore the efficacy of…

Phase 2 INSPIRE trial: Ipilimumab with Nivolumab in molecular-Selected patients with castration-resistant PRostate cancer

This study has been transitioned to CTIS with ID 2024-513186-39-00 check the CTIS register for the current data. Primary objective:To evaluate the efficacy of nivolumab in combination with ipilimumab in molecular pre-selected patients with…

The Treatment of Breast Cancer with PercutaneousThermal Ablation: A phase 2 screening trial

The overall study aim is to determine the efficacy rate of complete ablation for the most promising types of thermal ablation (RFA, MWA or CA) technique for patients with early stage breast cancer (cT1N0M0) without an extensive component of DCIS (…

A pilot study on oral esketamine for depression and demoralization in patients with advanced cancer receiving palliative care

Evaluation of the feasibility of a trial on the efficacy of oral esketamine for the treatment of depression and/or demoralization in patients with advanced cancer who receive palliative care.

Prostatic Artery Injection vs Intra-Venous Injectin of 18F-DCFPyL to evaluate treatment strategy in Prostate cancer

Primary Objective: • To evaluate the ability to concentrate the radiotracer in prostatic cancer lesions ( with respect to accumulation in background tissues) by prostatic artery injection (PAI), especially within the prostate gland compared to…

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…

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…