Mass General - Division of Clinical Research

The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 as a monotherapy, in double combination with Azacitidine and in triple combination with Azacitidine and Venetoclax in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Type: Interventional

Start Date: May 2024

open study

The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).

Type: Interventional

Start Date: Jan 2025

open study

The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 111 weeks including screening, treatment phases, and follow-up.

Type: Interventional

Start Date: Jul 2024

open study

This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.

Type: Interventional

Start Date: Mar 2024

open study

This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.

Type: Interventional

Start Date: May 2024

open study

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intrathecal (IT) delivery of ION717.

Type: Interventional

Start Date: Jan 2024

open study

The primary objective of this phase III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.

Type: Interventional

Start Date: Sep 2023

open study

The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival.

Type: Interventional

Start Date: Jan 2024

open study

This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.

Type: Interventional

Start Date: Oct 2023

open study

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.

Type: Interventional

Start Date: May 2023

open study

The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

Type: Interventional

Start Date: Oct 2023

open study

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

Type: Observational [Patient Registry]

Start Date: Jan 2019

open study

This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called "study drug[s]"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs). The study has 2 parts. The aim of the first part (dose escalation) is to find a safe dose of REGN5837 when given in combination with odronextamab. The goal of the second part (dose expansion) is to use the REGN5837 drug dose found in the first part to see how well REGN5837 in combination with odronextamab works. The study is looking at several other research questions, including: - What side effects may happen from taking the study drugs - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)

Type: Interventional

Start Date: Apr 2023

open study

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.

Type: Interventional

Start Date: Jan 2023

open study

The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib. All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib. Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.

Type: Interventional

Start Date: Jul 2022

open study

We are doing this research to identify biomarkers in individuals who are at-risk for familial prion disease. We hope to use these biomarkers to predict timing of disease onset in pre-symptomatic individuals and to guide the direction of future clinical trials.

Type: Observational [Patient Registry]

Start Date: Dec 2017

open study

This research is being done to assess the quality of life and symptom burden in participants who receive (normal tissue sparing whole brain radiation therapy (NTS-WBRT). This research study involves: - NTS-WBRT (normal tissue sparing whole brain radiation therapy) - Memantine standard of care drug

Type: Interventional

Start Date: Feb 2022

open study

This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: - Trastuzumab-emtansine (T-DM1, Kadcyla) - Trastuzumab SC (Herceptin Hylecta) - Paclitaxel

Type: Interventional

Start Date: Jun 2021

open study

The focus of this study is to test the efficacy of a 12-week, phone-delivered Positive Psychology-Motivational Interviewing (PP-MI) intervention, with additional twice weekly PP and health behavior text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to an attention-matched MI-based educational condition, in a randomized trial (NIH Stage II) of 280 patients with New York Heart Association class I-III Heart Failure (HF).

Type: Interventional

Start Date: Nov 2021

open study

DL-VSU-201 is a randomized, double-blind, placebo-controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of MTX-001.

Type: Interventional

Start Date: Feb 2022

open study

The investigators hypothesize that a simple 3-point tracking device that uses motion sensors attached to the abdomen and chest of a child will provide information regarding thoracoabdominal asynchrony (TAA), a major component of respiratory distress, and ultimately help guide a clinician to initiate, escalate, de-escalate, or stop respiratory support interventions. AIMS To determine if the TAA-monitoring device can be used to detect differences in respiratory synchrony in a manner that is clinically applicable. The investigators hope that the device will detect 1) major asynchrony events in a timely manner so as to prompt clinician intervention during future use; and 2) asynchrony events that may be less visible to the naked eye that may be precursors to more severe events.

Type: Interventional

Start Date: Oct 2020

open study

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Type: Interventional

Start Date: Jun 2020

open study

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.

Type: Interventional

Start Date: Aug 2018

open study

This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

Type: Interventional

Start Date: Sep 2017

open study

The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes. The objectives of the Registry are: - To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention. - To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. - To characterize the Pompe disease population. - To evaluate the long-term effectiveness of alglucosidase alfa.

Type: Observational [Patient Registry]

Start Date: Sep 2004

open study