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NCT ID: NCT04704154 Active, not recruiting - Solid Tumors Clinical Trials

A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors

Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts. The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion). The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years. During the trial, the doctors will take pictures of the participants' tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants' heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems.

NCT ID: NCT04703192 Active, not recruiting - Clinical trials for Relapsed/Refractory Peripheral T-Cell Lymphoma

Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

Start date: June 3, 2021
Phase: Phase 2
Study type: Interventional

This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.

NCT ID: NCT04700124 Active, not recruiting - Bladder Cancer Clinical Trials

Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

KEYNOTE-B15
Start date: April 21, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

NCT ID: NCT04697628 Active, not recruiting - Cervical Cancer Clinical Trials

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

innovaTV 301
Start date: February 22, 2021
Phase: Phase 3
Study type: Interventional

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

NCT ID: NCT04686136 Active, not recruiting - Chronic Migraine Clinical Trials

A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine

Start date: February 19, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine

NCT ID: NCT04685473 Active, not recruiting - Clinical trials for Advanced Refractory Solid Tumors

Safety and Tolerability Study for T-1101 (Tosylate) Capsules to Treat Advanced Refractory Solid Tumors

Start date: January 7, 2021
Phase: Phase 1
Study type: Interventional

T-1101 (Tosylate) is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by Taivex Therapeutics Corp. T-1101 (Tosylate) is a potent anti-cancer agent in numerous human cancer cell lines. In addition, oral administration of T-1101 (Tosylate) showed tumor growth inhibition in different mouse xenograft models of human cancers. In this study, safety, tolerability and pharmacokinetic (PK) of T-1101 (Tosylate) capsules will be evaluated and also the recommended dose and regimen(s) to initiate Phase 2 will be determined.

NCT ID: NCT04680052 Active, not recruiting - Follicular Lymphoma Clinical Trials

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

InMIND
Start date: April 15, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

NCT ID: NCT04675047 Active, not recruiting - Healthy Clinical Trials

Multimodal Brain Decoding of Pain Sensitivity

Start date: September 10, 2019
Phase:
Study type: Observational

Pain is the leading cause of disability worldwide. However, the pain sensitivity of individuals varies to a large extent, which often results in the mismatch between clinical diagnosis or treatment and individual's actual needs. There are still no established objective indicators for comparisons between individuals. This integrated pilot project is the first large-scale, multi-modal brain decoding study for pain sensitivity. We will explore the brain network signature of pain sensitivity by analyzing electroencephalogram (EEG) signals and magnetic resonance imaging (MRI.) Meanwhile, we will integrate the innate, environmental, and humanity factors with aforementioned brain network signatures to establish multi- modal objective model of pain sensitivity using machine learning. This research team is composed of more than 30 physicians, scientists, and IT experts, along with international collaborators with expertise in the fields of neuroscience, medical imaging, and human philosophy. The five elite groups constitute this international research team and establish five multi-disciplinary sub-projects: Sub-project A: Pain sensitivity and associated innate and environmental factors Sub-project B: Electrophysiological brain signatures of pain sensitivity Sub-project C: MRI brain signatures of pain sensitivity Sub-project D: Innovative brain computer interface (BCI) technology in pain sensitivity measurement and prediction Sub-project E: Pain and Art: neuro-mental mechanisms and potential applications There are three key features of this integrated project: scientific novelty, technology and humanity. In terms of scientific novelty, in addition to machine learning and big data applications, we will focus on the deep brain structure such as brainstem, in which the image acquisition has been difficult in the past. We will develop an MRI sequence and EEG protocol optimized for brainstem. In terms of technology, we will develop a wearable EEG cap implanted with algorithm chip for clinical measurement to decode the pain sensitivity real time. In terms of humanity, we will combine music and painting appreciation to explore their impact on brain signatures related to pain sensitivity. Furthermore, we will develop potential applications of art intervention in pain modulation. We expect this pilot project to achieve the four following goals: 1. To establish a Taiwan database of pain sensitivity. Meanwhile, to clarify the interactions between the innate and environmental factors of the individual and the brain network, and to identify brain signatures related to pain sensitivity. (sub- projects A, B, C) 2. To confirm the brain signatures for predicting the pain sensitivity using machine learning. In addition, to develop wearable devices such as EEG cap for large sample screening by combining the brain-computer interface through the industry-university cooperation (sub-projects B, C, D) 3. To explore the plasticity of brain signatures related to pain sensitivity by sensory modulation such as music, painting appreciation or transcutaneous electrical nerve stimulation, and to explore the application potential for pain modulation (sub-projects B, C, D, E) 4. Based on the cooperation model of this international research team, we will cultivate young researchers, and promote academic interactions among different team members, and improve the international visibility and competitiveness of Taiwan (sub-projects A, B, C, D, E)

NCT ID: NCT04666038 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

BRUIN CLL-321
Start date: March 9, 2021
Phase: Phase 3
Study type: Interventional

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

NCT ID: NCT04665843 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

SKYSCRAPER-09
Start date: March 2, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.