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Displaying 1 - 20 of 1003

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

A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)

The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic active AMR.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Jessie Hsu
Open Actively Recruiting

Trial of 225Ac-DOTATATE (RYZ101) Alone and with Pembrolizumab in Subjects with ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs

Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) alone and with pembrolizumab in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.

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

Dose Escalation and Expansion of BBO-10203 in Advanced Solid Tumors (BREAKER-101)

First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with trastuzumab in patients with advanced solid tumors.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Bhavisha Tailor
Open Actively Recruiting

Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: LISA-MARIA YONEMOTO
Open Actively Recruiting

CATALINA-2: a Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.

A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.

Phase: Phase 2
Primary Purpose: Treatment
Gender: Female
Age Group: Adults
Contact: Cynthia Avina

Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Rana Nikbakht Malvajerdi
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

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)

This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: MARIA ZAMUDIO
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

FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101)

This is a phase 1 study of FT522 administered with rituximab in participants with relapsed/refractory B-cell lymphoma (R/R BCL). The primary objectives of the study are to evaluate the safety and tolerability of FT522 in combination with rituximab, and to determine the recommended phase 2 dose (RP2D) of FT522 in combination with rituximab; each objective will be assessed with or without conditioning chemotherapy.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Bruck Habtemariam
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

Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies

GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal antibody (DFA). This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in adults with advanced malignancies.

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

Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Children
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

ROBOT - ROme foundation research institute BiOmarker and phenotyping projecT

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Open Actively Recruiting

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults, Children
Contact: Bruck Habtemariam
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