Mass General - Division of Clinical Research

GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531 exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs).

Type: Interventional

Start Date: May 2024

open study

The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS). Participants will be asked to: 1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods 2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour

Type: Interventional

Start Date: Mar 2024

open study

To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP.

Type: Interventional

Start Date: Dec 2023

open study

The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.

Type: Interventional

Start Date: Dec 2023

open study

Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.

Type: Observational

Start Date: Sep 2023

open study

SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke.

Type: Interventional

Start Date: Mar 2024

open study

The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.

Type: Interventional

Start Date: Oct 2023

open study

The goal of this study is to learn about a new, real-time, smartphone-based intervention aimed to decrease risk for suicide in adults who have been hospitalized for suicidal thoughts or behaviors. The main questions the investigators aim to answer are: - Is a real-time, smartphone-based intervention that promotes the use of safety plans and other coping strategies for suicidal thoughts feasible and acceptable? - Does the real-time intervention result in increased use of safety plans and other coping strategies, and reduce suicidal thoughts? Participants will: - Answer questions about current suicidal thoughts on their smartphone up to 6 times each day while they are in the hospital and during the 4 weeks after they leave the hospital - When they report elevated suicidal thoughts on a smartphone survey, be randomly assigned to receive or not receive automated, interactive reminders to use content from their personalized safety plan or general coping strategies - Answer brief follow-up questions on their smartphone within a couple hours of receiving or not receiving automated reminders - Give feedback on their experience with the real-time intervention

Type: Interventional

Start Date: Jul 2023

open study

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Type: Interventional

Start Date: Nov 2023

open study

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

Type: Interventional

Start Date: Mar 2023

open study

The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that scientists can request to use in their research. The samples we collect are all linked to clinical data in the TSC Natural History Database. The TSC Natural History Database captures clinical data to document the impact of the disease on a person's health over his or her lifetime. This data may be collected retrospectively or prospectively.

Type: Observational [Patient Registry]

Start Date: Jan 2016

open study

The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (< 50%).

Type: Interventional

Start Date: Mar 2023

open study

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435. 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

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.

Type: Interventional

Start Date: Dec 2022

open study

The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy aged 12 years and above. The duration of participants participation will be up to 4 weeks for screening, treatment until clinically significant progression of disease, and 4 weeks of safety follow-up, and then long-term follow-up every 12 weeks.1 Cycle = 28 days.

Type: Interventional

Start Date: Sep 2024

open study

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: - is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy - is sensitive to hormonal therapy (it is called estrogen receptor positive); and - is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study A: All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective. Participants will continue to take ARV-471 and abemaciclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks.

Type: Interventional

Start Date: Feb 2023

open study

This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA.

Type: Interventional

Start Date: Oct 2022

open study

Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Type: Interventional

Start Date: Sep 2022

open study

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

Type: Interventional

Start Date: Jul 2022

open study

The purpose of this 8-week double-blind randomized placebo-controlled study is to assess the tolerability, safety, and efficacy of tPBM in adult patients with ASD.

Type: Interventional

Start Date: Feb 2022

open study

The current project will (1) enhance our understanding of the neurobiology of chronic post-surgical pain (CPSP); (2) provide a metric to follow patients with CPSP in the clinic; (3) provide a metric for those who will chronify; and (4) understand the age-related differences in CPSP. Ultimately, an improved comprehension of mechanisms linked to CPSP will provide finer tools for optimizing the selection of treatments for individual patients. Moreover, data that demonstrates the underlying pathobiological pain mechanism(s) active in CPSP, particularly those non-responsive to current therapies, may be used to validate novel strategies both pharmacological and non-pharmacological.

Type: Interventional

Start Date: Apr 2022

open study

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07220060 and PF-07104091) in people with breast cancer. This clinical study consists of 2 parts (part 1 and part 2). In part 1, we are seeking participants who: - Have been diagnosed with Breast Cancer (BC) of either types: - Have HR+, HER2- BC - Refractory HR-positive/HER2-positive BC - Have other solid tumors other than BC In part 2, we are seeking participants who: -Have HR-positive/HER2-negative BC Part 1 will include increasing doses of PF-07220060 with PF-07104091. In part 2, participants will take 1 of 2 study medicine combinations. This will help us decide the highest amount of study medicines that can be safety given to people. All participants in this study will receive PF-07220060 with PF-07104091 by mouth. We will compare participant experiences to help us determine if PF-07220060 with PF-07104091 is safe and effective. Participants will take part in this study for about 2 years. During this time, they will receive the study medicine, an x-ray imaging, and will be observed for safety and effects of the study medicines.

Type: Interventional

Start Date: Mar 2022

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

The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.

Type: Interventional

Start Date: Aug 2022

open study

Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion, first-in-human (FIH) clinical study of CC-91633 (BMS-986397) in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The Dose Escalation part (Part A) of the study will enroll participants with R/R AML and R/R HR-MDS and will evaluate the safety and tolerability of escalating doses of CC-91633 (BMS-986397), administered orally, and determine the maximum tolerated dose (MTD) or preliminary recommended Phase 2 doses (RP2D) and schedule. Throughout the study, final decisions on dose escalation/de-escalation will be made by the safety review committee (SRC). Approximately 60 participants may be enrolled in Part A of the study. The expansion part (Part B) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development. Approximately 60 response-evaluable subjects per indication (R/R AML or R/R HR-MDS) may be enrolled. Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

Type: Interventional

Start Date: Dec 2021

open study