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A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therap1
Celgene
Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the
investigator's choice of therapy in participants with Metastatic Castration-resistant
Prostate Cancer. expand
The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer. Type: Interventional Start Date: Mar 2025 |
A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
Biogen
Antibody-mediated Rejection
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. expand
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. Type: Interventional Start Date: Dec 2024 |
Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LAB1
Regeneron Pharmaceuticals
Asthma
This study is researching a drug called dupilumab. The study is focused on patients who
have uncontrolled asthma. Asthma is a condition where the airways narrow and swell,
making it difficult to breathe. Uncontrolled asthma means that patients are still having
frequent symptoms while taking their c1 expand
This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: • What side effects may happen from taking dupilumab Type: Interventional Start Date: Aug 2024 |
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydro1
CereVasc Inc
Normal Pressure Hydrocephalus
Prospective, multi-center, randomized, controlled trial of the eShunt System in the
treatment of patients with normal pressure hydrocephalus. expand
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus. Type: Interventional Start Date: Nov 2024 |
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
Celldex Therapeutics
Chronic Spontaneous Urticaria
The purpose of this study is to establish the efficacy, safety and tolerability of
barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately
controlled by non-sedating second generation H1-antihistamines in comparison to placebo. expand
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo. Type: Interventional Start Date: Jul 2024 |
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in1
Celgene
Large B-cell Lymphoma
The purpose of this study is to compare the effectiveness and safety of golcadomide in
combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
(R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants
with previously untreated high-risk1 expand
The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL). Type: Interventional Start Date: Jun 2024 |
A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera M1
Ajax Therapeutics, Inc.
Primary Myelofibrosis
Post-Essential Thrombocythemia Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
PMF
PPV-MF
AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label
clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK),
clinical activity and changes in biomarkers of an orally administered type II JAK2
inhibitor, AJ1-11095, in subjects with prim1 expand
AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), clinical activity and changes in biomarkers of an orally administered type II JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor. Type: Interventional Start Date: Oct 2024 |
Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Partic1
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Multiple Myeloma
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene
Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma. expand
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma. Type: Interventional Start Date: Mar 2024 |
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy f1
Jazz Pharmaceuticals
Biliary Tract Cancer
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus
CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death
protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or
Pembrolizumab, where approved under local reg1 expand
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. Type: Interventional Start Date: Jul 2024 |
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
GB002, Inc.
Pulmonary Arterial Hypertension
This open-label extension study will evaluate the long-term safety, tolerability and
efficacy of orally inhaled seralutinib in subjects who have completed a previous
seralutinib study expand
This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study Type: Interventional Start Date: Sep 2024 |
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advance1
Regeneron Pharmaceuticals
Melanoma
This study is researching an experimental drug called fianlimab (also known as REGN3767),
combined with another medication called cemiplimab (also known as REGN2810), called
"study drugs". The study is focused on patients with a type of skin cancer known as
melanoma. The aim of the study is to see1 expand
This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children. 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 (which could make the drug less effective or could lead to side effects) Type: Interventional Start Date: Sep 2024 |
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
BicycleTx Limited
Metastatic Urothelial Cancer
This is a global, multicenter, randomized, open-label study, with an adaptive design. The
main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide
pevedotin) as monotherapy and in combination with pembrolizumab in participants with
locally advanced or metastatic urot1 expand
This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC. Type: Interventional Start Date: Jan 2024 |
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sc1
Sanofi
Multiple Sclerosis
The purpose of each study is to independently measure the annualized relapse rate (ARR)
with administration of frexalimab compared to a daily oral dose of teriflunomide in male
and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years
at the time of enrollment). People1 expand
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. - The study intervention duration will vary ranging from approximately 12 to 40 months. - The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months. Type: Interventional Start Date: Dec 2023 |
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Pati1
Eli Lilly and Company
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
The purpose of this study is to assess if adding LY3537982 in combination with standard
of care anti-cancer drugs is more effective than standard of care in participants with
untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study
participation, including follow-up, cou1 expand
The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing. Type: Interventional Start Date: Dec 2023 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progr1
Bristol-Myers Squibb
Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in Participants with Progressive Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Effica1
Novartis Pharmaceuticals
Sjogrens Syndrome
The purpose of this study is to measure the long-term safety and tolerability of
ianalumab in participants with Sjogrens syndrome who have previously completed treatment
from one of two NEPTUNUS 1 year core studies (CVAY736A2301 [NCT05350072] or CVAY736A2302
[NCT05349214]).
- The study treatmen1 expand
The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 [NCT05350072] or CVAY736A2302 [NCT05349214]). - The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe (PFS) or in a 2 mL autoinjector (AI) for injection. All participants will receive ianalumab either monthly or every 3 months. - The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years. - The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up. Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding. Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study. Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens: - ianalumab 300 mg monthly or - ianalumab 300 mg once every 3 months Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study. Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe or a 2 mL autoinjector. Participants will be given the opportunity to self-inject at home on some visits after receiving training. Type: Interventional Start Date: Oct 2023 |
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Pos1
Novartis Pharmaceuticals
Oligometastatic Prostate Cancer (OMPC)
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu)
vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer
(OMPC) progressing after definitive therapy to their primary tumor. The data generated
from this study will provide evidence for t1 expand
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT). Type: Interventional Start Date: Mar 2024 |
Assessment of Combined CCM and ICD Device in HFrEF
Impulse Dynamics
Heart Failure
Heart Failure With Reduced Ejection Fraction
Implantable Defibrillator User
CCM Therapy
Non-ischemic Cardiomyopathy
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D
System (the "CCM-D System") can safely and effective convert induced ventricular
fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation
(VT/VF) episodes in subjects with Stage C or1 expand
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years. Type: Interventional Start Date: May 2023 |
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autolog1
Bristol-Myers Squibb
Multiple Myeloma
The purpose of this study is to compare the effectiveness of iberdomide maintenance to
lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in
participants with newly diagnosed multiple myeloma (NDMM). expand
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM). Type: Interventional Start Date: Jun 2023 |
A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary1
Genentech, Inc.
Idiopathic Pulmonary Fibrosis
Systemic Sclerosis With Lung Involvement
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with
placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in
participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Participants who complete 52-weeks of1 expand
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is enrolling participants. Type: Interventional Start Date: May 2023 |
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Aza1
Kura Oncology, Inc.
Acute Myeloid Leukemia
Mixed Lineage Acute Leukemia
Mixed Lineage Leukemia Gene Mutation
Mixed Phenotype Acute Leukemia
Refractory AML
This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic
activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and
7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r. expand
This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r. Type: Interventional Start Date: Jul 2023 |
LGMD R1 Natural History Study
Virginia Commonwealth University
Calpain-3 Deficiency Limb Girdle Muscular Dystrophy Type 2A
Limb Girdle Muscular Dystrophy
Limb Girdle Muscular Dystrophy Type R1
LGMD2A
This is a 24-month, observational study of 100 participants with Limb Girdle Muscular
Dystrophy type R1, also known as CAPN3. expand
This is a 24-month, observational study of 100 participants with Limb Girdle Muscular Dystrophy type R1, also known as CAPN3. Type: Observational Start Date: Jan 2024 |
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
Genmab
High Grade Epithelial Ovarian Cancer
High Grade Serous Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Endometrial Cancer
This study will test the safety, including side effects, and determine the
characteristics of a drug called Rina-S in participants with solid tumors.
Participants will have solid tumor cancer that has spread through the body (metastatic)
or cannot be removed with surgery (unresectable). expand
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). Type: Interventional Start Date: Dec 2022 |
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Alliance for Clinical Trials in Oncology
Cigarette Smoking-Related Carcinoma
This phase III trial compares the effect of text-based cessation intervention to a manual
in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction
may reduce the frequency of cigarette use to zero and may be effective in quitting
smoking. expand
This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking. Type: Interventional Start Date: Apr 2022 |
Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
Alliance for Clinical Trials in Oncology
Angioimmunoblastic T-cell Lymphoma
Enteropathy-Associated T-Cell Lymphoma
Follicular T-Cell Lymphoma
Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy
consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in
treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of
cancer cells by blocking some of the enzyme1 expand
This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help find out if this approach is better or worse than the usual approach for treating peripheral T-cell lymphoma. Type: Interventional Start Date: Oct 2021 |
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