
Search Clinical Trials
Below please find a list of studies actively recruiting volunteers at one of the following GHUCCTS institutions: Georgetown University, Howard University, MedStar Health Research Institute, or Washington DC VA Medical Center. Please enter your search criteria below to help find a study for you. If you have any questions, please email us or call us at 301-560-2963.
Sponsor Condition of Interest |
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A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
AbbVie
Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness,
swelling and loss of joint function. This study will evaluate the efficacy and safety of
targeted therapies through a series of substudies for the treatment of moderately to
severely active Rheumatoid Arthritis (RA1 expand
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. 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: Jun 2025 |
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Dise1
BlueRock Therapeutics
Parkinsons Disease (PD)
Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled,
double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102
adults with Parkinson's Disease (PD). expand
Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD). Type: Interventional Start Date: Jun 2025 |
Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
AbbVie
Psoriatic Arthritis
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune
system attacks healthy cells and tissues causing joint pain, stiffness, and swelling.
Symptoms can get worse and go away for periods of time. This study will evaluate the
efficacy and safety of targeted therapies t1 expand
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms. The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). 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: Apr 2025 |
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Eli Lilly and Company
Immune Thrombocytopenia (ITP)
The purpose of the phase 1 part of this study is to evaluate how well pirtobrutinib is
tolerated and what side effects may occur. The phase 2 part of the study will further
investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo.
The study drug will be administered orally1 expand
The purpose of the phase 1 part of this study is to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo. The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening. Type: Interventional Start Date: Jul 2025 |
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With C1
Pfizer
COVID-19 SARS-CoV-2 Infection
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in
adults and adolescents with COVID-19 who do not need to be in the hospital but who are at
high risk for progression to severe disease. Eligible participants will be randomly
assigned (by chance) to receive ibuzatr1 expand
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months. Type: Interventional Start Date: Dec 2024 |
Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non1
Alliance for Clinical Trials in Oncology
Resectable Lung Non-Small Cell Carcinoma
Stage II Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
This phase III trial compares standard therapy given after surgery (adjuvant) to standard
therapy given before and after surgery (perioperative) in treating patients with stage
II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable).
The usual approach for patients wi1 expand
This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, 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 . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC. Type: Interventional Start Date: Dec 2024 |
The Protrieve PROTECTOR Study
Inari Medical
Venous Thromboembolism
Deep Venous Thrombosis
The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the
Protrieve Sheath. expand
The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath. Type: Interventional Start Date: Mar 2025 |
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Livi1
Eli Lilly and Company
Atherosclerotic Cardiovascular Disease (ASCVD)
Chronic Kidney Disease (CKD)
The main purpose of this study is to determine if retatrutide can significantly lower the
incidence of serious heart-related complications or prevent the worsening of kidney
function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and
Atherosclerotic Cardiovascular Disease an1 expand
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor. Type: Interventional Start Date: Apr 2024 |
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
Seagen, a wholly owned subsidiary of Pfizer
Breast Neoplasms
Gastroesophageal Junction Adenocarcinoma
HER2 Low Breast Neoplasms
HER2 Positive Breast Neoplasms
Stomach Neoplasms
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in
part of your body like your lungs or liver instead of your blood. Once they've grown
bigger in one spot or spread to other parts of the body, they're harder to treat. This is
called advanced or metastatic cance1 expand
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer. Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®. This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease. Type: Interventional Start Date: May 2024 |
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Rel1
Hoffmann-La Roche
Lymphoma
The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared
with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide
with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma
(MCL). expand
The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). Type: Interventional Start Date: Oct 2023 |
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Gilead Sciences
Primary Biliary Cholangitis
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary
Biliary Cholangitis (PBC) and Compensated Cirrhosis. expand
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis. Type: Interventional Start Date: Sep 2023 |
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherap1
National Cancer Institute (NCI)
Muscle Invasive Bladder Urothelial Carcinoma
Muscle Invasive Renal Pelvis Urothelial Carcinoma
Muscle Invasive Ureter Urothelial Carcinoma
Muscle Invasive Urethral Urothelial Carcinoma
Stage II Bladder Urothelial Carcinoma AJCC v6 and v7
This phase II/III trial examines whether patients who have undergone surgical removal of
bladder, kidney, ureter or urethra, but require an additional treatment called
immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back,
can be identified by a blood test. Many typ1 expand
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra. Type: Interventional Start Date: Feb 2024 |
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Xenon Pharmaceuticals Inc.
Primary Generalized Tonic-Clonic Seizures
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as
adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). expand
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). Type: Interventional Start Date: Feb 2023 |
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Massachusetts General Hospital
Myocarditis Acute
Cancer
The primary aim is to test whether abatacept, as compared to placebo, is associated with
a reduction in major adverse cardiac events (MACE) among participants hospitalized with
myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE,
is a composite of first occurren1 expand
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure. Type: Interventional Start Date: Jul 2022 |
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin,1
Novartis Pharmaceuticals
Extensive Stage Small Cell Lung Cancer
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in
combination with carboplatin, etoposide and atezolizumab in this setting and to assess
preliminary efficacy of this combination treatment versus the combination of carboplatin,
etoposide, and atezolizumab.The stud1 expand
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type. Type: Interventional Start Date: Jul 2022 |
Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC1
Verastem, Inc.
Non Small Cell Lung Cancer
KRAS Activating Mutation
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination
with sotorasib with or without defactinib in patients with KRAS G12C Non-Small Cell Lung
Cancer (NSCLC) in patients who have been exposed to prior G12C inhibitor and those who
have not been exposed to prior G12C1 expand
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with sotorasib with or without defactinib in patients with KRAS G12C Non-Small Cell Lung Cancer (NSCLC) in patients who have been exposed to prior G12C inhibitor and those who have not been exposed to prior G12C inhibitor. Type: Interventional Start Date: Apr 2022 |
Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation1
NRG Oncology
Metastatic Lung Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Brain
Recurrent Lung Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
This phase III trial compares the effect of stereotactic radiosurgery to standard of care
memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone
of the brain) for the treatment of small cell lung cancer that has spread to the brain.
Stereotactic radiosurgery is a s1 expand
This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine. Type: Interventional Start Date: Jun 2021 |
Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the1
National Cancer Institute (NCI)
Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
This phase II trial studies the effect of pembrolizumab alone compared to the usual
approach (chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery
in treating patients with head and neck squamous cell carcinoma that has come back
(recurrent) or patients with a second head1 expand
This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma. Type: Interventional Start Date: Apr 2021 |
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable1
National Cancer Institute (NCI)
Autoimmune Disease
Crohn Disease
Dermatomyositis
Hematopoietic and Lymphoid Cell Neoplasm
Inflammatory Bowel Disease
This phase Ib trial studies the side effects of nivolumab and to see how well it works in
treating patients with autoimmune disorders and cancer that has spread to other places in
the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as
nivolumab, may help the body's1 expand
This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: Jul 2019 |
The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI
Georgetown University
Breast Neoplasm Female
Early Detection of Cancer
Hereditary Breast and Ovarian Cancer Syndrome
Magnetic Resonance Imaging
The purpose of this study is to test the impact of a multilevel decision support
intervention on informed decisions about breast MRI among high-risk Black and Latina
women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment
+ referral to nurse practitioner) or (2) de1 expand
The purpose of this study is to test the impact of a multilevel decision support intervention on informed decisions about breast MRI among high-risk Black and Latina women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment + referral to nurse practitioner) or (2) decision support (enhanced usual care + decision aid). Assessments will take place at baseline (T0) and 1-month post-intervention (T1). The primary outcome is informed decisions about breast MRI at T1. Type: Interventional Start Date: Jun 2025 |
A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine1
Ipsen
Episodic Migraine
Chronic Migraine
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on
one side of the head. It is often accompanied by feeling or being sick and a sensitivity
to bright lights and sound. Migraines are caused by a series of events when the brain
gets stimulated or activated, which1 expand
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. IPN10200 is a medication that stops the release of these chemical messengers. Participants with episodic migraine (EM) or chronic migraine (CM) will be included in both Step 1 and Step 2. "Headache days" are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms. "Migraine days" occur when the headache displays clear migraine characteristics. This study aims to determine: - The safety and efficacy of injecting IPN10200 directly into the muscles of the head and neck to prevent EM and CM, - The right amount (dose) of IPN10200 to inject at each point, - The total amount (dose) of IPN10200 that provides the best balance between safety and efficacy preventing migraines. Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks. Type: Interventional Start Date: Oct 2024 |
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Allogene Therapeutics
Large B-cell Lymphoma
This is a randomized, open-label study in adult patients who have completed standard
first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or
partial response suitable for observation, but who have minimal residual disease (MRD) as
detected by the Foresight CLARITY™ I1 expand
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide. Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen. Type: Interventional Start Date: Jun 2024 |
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Seconda1
OSE Immunotherapeutics
Patients With Non-Small Cell Lung Cancer
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with
squamous and non-squamous metastatic NSCLC with ICI secondary resistance.
Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with
OSE2101 monotherapy or control Arm B SoC with doce1 expand
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1). Type: Interventional Start Date: Dec 2024 |
ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation1
Mannkind Corporation
MAC Lung Disease
Treatment Refractory MAC Lung Disease
Mycobacterium Infections, Nontuberculous
This clinical trial is designed to compare the efficacy and safety of Clofazimine
Inhalation Suspension versus placebo when added to guideline-based therapy (GBT) expand
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT) Type: Interventional Start Date: Sep 2024 |
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multi1
Sanofi
Relapsing Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Progressive Relapsing Multiple Sclerosis
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and
tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or
NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3
tolebrutinib pivotal trials (GEMI1 expand
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]). SUBSTUDY: ToleDYNAMIC substudy Type: Interventional Start Date: Apr 2024 |
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