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NCT ID: NCT04591431 Active, not recruiting - Breast Cancer Clinical Trials

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

ROME
Start date: October 7, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, prospective, multicenter, Proof of Concept, Phase II clinical trial Study. The main objective of the study is to evaluate the efficacy (meant as overall response rate ORR) of TT (targeted Therapy) vs SoC (standard of Care) in patients with progressive disease (recurrent and/or metastatic) of breast cancer, metastatic gastro-intestinal tumors, non small cell lung cancer (NSCLC) or others. Patients should have completed at least 1 line of treatment and no more than 2 as defined by the current version of the AIOM (Italian Association of Medical Oncology) guidelines. Patients are included if surgery is contraindicated.

NCT ID: NCT04590963 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

INTERLINK-1
Start date: October 2, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer.

NCT ID: NCT04586231 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.

NCT ID: NCT04586023 Active, not recruiting - Clinical trials for Relapsing Multiple Sclerosis

Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

FENhance 2
Start date: March 24, 2021
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

NCT ID: NCT04586010 Active, not recruiting - Clinical trials for Relapsing Multiple Sclerosis

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

FENhance
Start date: March 17, 2021
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

NCT ID: NCT04584957 Active, not recruiting - Gynecologic Cancer Clinical Trials

Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.)

GO-VAC
Start date: September 18, 2020
Phase: N/A
Study type: Interventional

A prospective controlled randomized study aimed to prospectively evaluate, the impact and effectiveness of clean incision prophylactic vacuum negative pressure therapy on wound healing (ciNPWT) in women at high risk of developing wound complications who undergo major gynecologic surgery. Gynecologic Oncology patients appear to be more at risk of developing wound complications than the general surgery population, reaching infection rates of 36 vs. 24 % that become 40 and 60% for obese and morbidly obese patients, respectively. Data about the use of ciNPWT are few, controversial and are of poor quality. No randomized, controlled trials have yet been reported in support of the use of ciNPWT in the gynecologic population.

NCT ID: NCT04583683 Active, not recruiting - Obesity Clinical Trials

Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities

ARGOS
Start date: September 30, 2020
Phase: N/A
Study type: Interventional

It is a prospective randomized trial on 218 subjects, 109 for each arms. The purpose of this trial is to compare very low calorie diet and metabolic surgery induced weight loss and its maintenance.

NCT ID: NCT04582539 Active, not recruiting - Multiple Myeloma Clinical Trials

To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma

LIMBER
Start date: August 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.

NCT ID: NCT04581824 Active, not recruiting - Clinical trials for Lung Cancer, Non-Small Cell

Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

Start date: November 19, 2020
Phase: Phase 2
Study type: Interventional

NSCLC comprises of approximately 84 percent (%) of all lung cancers and is often diagnosed at advanced stage due to poor prognosis. Dostarlimab is an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody (mAb) that binds with high affinity to programmed cell death protein 1 (PD 1), resulting in inhibition of binding to programmed death ligand 1 (PD L1) and programmed death ligand 2 (PD L2). This study aims to compare the efficacy and safety PD-1 inhibitors dostarlimab and pembrolizumab, when administered in combination with chemotherapy (pemetrexed, cisplatin and carboplatin), in participants with non-squamous NSCLC without a known sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or receptor tyrosine kinase-1 (ROS-1) mutation, BRAF V600E mutation, or other genomic aberration for which an approved targeted therapy is available. A total of approximately 240 participants will be enrolled in the study for a period of 5 years.

NCT ID: NCT04579679 Active, not recruiting - Clinical trials for Neuroendocrine Tumours

Open-Label Surufatinib in European Patients With NET

Start date: August 13, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, multi-centre study of surufatinib in patients with low to intermediate grade (Grade 1 or Grade 2), well-differentiated neuroendocrine tumours (NETs).