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A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Monica Rocha
Open Actively Recruiting

Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.

Phase: Phase 3
Primary Purpose: Prevention
Gender: All
Age Group: Adults
Contact: BARBARA MILLS
Open Actively Recruiting

Parkinson's Foundation PD GENEration Genetic Registry

Development of a central repository for PD-related genomic data for future research.

Gender: All
Age Group: Adults
Contact: Diane Yang
Open Actively Recruiting

Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors

Conditions treated in intensive care units (ICUs) such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are common. These can lead to high rates of depression, anxiety, and PTSD that worsen quality of life. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about the experiences of patients from racially and ethnically minoritized populations because of they haven't been included well in past research.

To address this problem, the investigators developed Blueprint, a mobile app that coaches people to use adaptive coping skills to self-manage their symptoms. The investigators found that it reduced depression symptoms and improved quality of life compared to placebo.

To confirm these promising findings, the investigators are doing a formal test of Blueprint. The investigators will enroll 400 people who received ICU care from 4 hospitals (Duke, UCLA, Colorado, and Oregon). These patients will be randomized to receive either the Blueprint mobile app or a special Education Program mobile app the investigators developed. -both delivered through similar mobile app platforms. Our specific aims are to see which program improves symptoms better across 6 months of follow up.

This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity.

Phase: N/A
Primary Purpose: Supportive care
Gender: All
Age Group: Adults
Open Actively Recruiting

A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis

The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Jose Jesus Torres Salgado
Investigator: Edmund Tsui, MD
Open Actively Recruiting

A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Angela Lool
Open Actively Recruiting

AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Joanna Gutierrez
Open Actively Recruiting

CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR

This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of safety, acceptability, adherence, and PK/PD (sub-study only) are assessed for each product.

Phase: Phase 2
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Contact: Kevin Pizarro
Open Actively Recruiting

Vonafexor ALPort Syndrome Efficacy & Safety TRIAl-1 (ALPESTRIA-1)

This study is a proof-of-concept trial of vonafexor safety, its effects on kidney function in subjects with at risk of progression Alport syndrome.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Gabriel Munoz
Open Actively Recruiting

An Extension Study for Patients Previously Enrolled in Studies with Pelabresib

The purpose of this study is to provide continued access to treatment with pelabresib for patients who previously received pelabresib in a parent study and to continue collecting safety and efficacy information. By collecting efficacy information, the study team monitors if pelabresib helps the patient with their disease. Additionally, survival follow-up data will be collected. Survival follow-up collects information on the patient's leukemia-free survival and overall survival status (life span) during and after the treatment is ended. If a patient stopped pelabresib treatment on the parent study for any other reason than participation in this study, they will not receive further pelabresib treatment, but they can enter the study for survival-follow up only.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Bruck Habtemariam
Open Actively Recruiting

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Karla Largaespada
Open Actively Recruiting

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents.

The first three subprotocols include the following:

Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens

Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6

Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults

Long-term Extension of GTX-102 in Angelman Syndrome

The primary objective of the study is to evaluate the long-term safety profile of GTX-102 in participants with Angelman Syndrome (AS)

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Children
Contact: Natalie Solis
Open Actively Recruiting

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS).

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CINDY TONG
Open Actively Recruiting

A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)

To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Jacqueline Banuelos Murillo
Investigator: Arun S. Singh, MD
Open Actively Recruiting

Study of the CHK1 Inhibitor BBI-355, an EcDNA-directed Therapy (ecDTx), in Subjects with Tumors with Oncogene Amplifications

BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). This is a first-in-human, open-label, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with select therapies.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Open Actively Recruiting

A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion.

The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.

Phase: Phase 3
Primary Purpose: Treatment
Gender: Female
Age Group: Adults
Contact: Surya Nagesh
Investigator: Ritu Salani, MD
Open Actively Recruiting

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.

Phase: Phase 4
Primary Purpose: Diagnostic
Gender: All
Age Group: Adults
Contact: Ladda Douangvila-Chhan
Investigator: Rushi Parikh, MD
Open Actively Recruiting

A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101, a novel anti VISTA IgG1 monoclonal antibody as monotherapy or in combination with cemiplimab in patients with advanced solid tumors.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Open Actively Recruiting

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Monica Rocha