Search Clinical Trials
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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Yale University
Intracerebral Hemorrhage
Atrial Fibrillation
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the
composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in
patients with recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared with aspirin, results in1 expand
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale. Type: Interventional Start Date: Jan 2020 |
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A Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystr1
ITF Therapeutics LLC
Duchene Muscular Dystrophy
This is a prospective observational study conducted to evaluate safety, tolerability, and
functional outcomes of patients with DMD newly initiating oral givinostat or having
started therapy within 6 months as part of routine clinical care in the US. The study has
a planned maximum duration of 5 yea1 expand
This is a prospective observational study conducted to evaluate safety, tolerability, and functional outcomes of patients with DMD newly initiating oral givinostat or having started therapy within 6 months as part of routine clinical care in the US. The study has a planned maximum duration of 5 years for the first enrolled patients, including a 24-month enrollment period and a minimum of 2 years of follow-up. Type: Observational Start Date: Oct 2025 |
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A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Ven1
AbbVie
Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells).
The purpose of this study is to assess the safety of venetoclax in combination with
obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in
disease activity will be assessed.
Venetoc1 expand
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. 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: Aug 2024 |
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PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing1
Duke University
Bronchopulmonary Dysplasia (BPD)
Premature Births
Critical Illness
The purpose of the study is to learn how safe montelukast may be in premature infants at
significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how
quickly montelukast moves from the stomach into the bloodstream, and how quickly it is
removed from the bloodstream.
Data1 expand
The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the bloodstream, and how quickly it is removed from the bloodstream. Data supporting the prospect of montelukast benefit involved 6 previous studies involving 206 preterm infants. The dosing ranged from 0.5 to 2.5 mg/kg/day, which aligns with the proposed initial dose of 0.75 mg/kg/day. Though each previous study had a small population, collectively they reveal montelukast as a promising drug in populations of preterm infants developing BPD and for individual preterm infants who are "developing BPD." Thus, researchers expect clinical benefit for preterm infants in this study. Despite the benefit-to-risk ratio presented by these previous studies, the optimal dose remains to be determined; thus, this study design and PK analysis will start with the lowest dose that is likely to provide direct benefit to participants. Type: Interventional Start Date: Feb 2026 |
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Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
C. R. Bard
Kidney Disease, End-Stage
End-stage Renal Disease
Arteriovenous Fistula
A prospective, single-arm, multi-center post-market surveillance study of the BD®
WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients
Requiring Dialysis. expand
A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis. Type: Interventional Start Date: Mar 2021 |
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A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For t1
RedDress Ltd.
Anal Fistula
The goal of this clinical trial is to assesses the safety of autologous RD2 Ver.02 as
compared to a control for managing transsphincteric and intersphinsteric anal fistulas.
The main questions it aims to answer are:
Assess the safety and efficacy of RD2 Ver.02 in anal fistula application, compare1 expand
The goal of this clinical trial is to assesses the safety of autologous RD2 Ver.02 as compared to a control for managing transsphincteric and intersphinsteric anal fistulas. The main questions it aims to answer are: Assess the safety and efficacy of RD2 Ver.02 in anal fistula application, compared to control. Complication rate by 6 months of anal fistula treatment with RD2 Ver.02 compared to control. Recurrence of anal fistula at 12 months post-treatment Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control. Patients will be randomized in to 2 arms. For all patients, blood will be drawn to ensure the blinding of the patients, the fistula will be evaluated and debrided, and then the internal fistula opening will be suture-closed, and a water leak test will be performed to ensure sealing. Following the water leak test, In the treatment arm, the patient's own coagulating blood will be applied into the entire fistula tract, allowing it to clot and serve as a provisional matrix inside the fistula tract. In the control arm, the blood sample will be discarded and saline will be applied to the fistula tract. Type: Interventional Start Date: Jan 2024 |
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Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion N1
Children's Oncology Group
Embryonal Rhabdomyosarcoma
Fusion-Negative Alveolar Rhabdomyosarcoma
Spindle Cell/Sclerosing Rhabdomyosarcoma
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This
phase III trial aims to maintain excellent outcomes in patients with very low risk
rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24
weeks of vincristine and dactinomycin (1 expand
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved. Type: Interventional Start Date: Aug 2022 |
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A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
Nicole Hamblett
Cystic Fibrosis
The REACH study is for people with CF who do not take cystic fibrosis transmembrane
conductance regulator (CFTR) modulators. The goal of the REACH study is to collect
research data, including health data and specimens, from people with CF who do not take
CFTR modulators. This data may be used to in1 expand
The REACH study is for people with CF who do not take cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The goal of the REACH study is to collect research data, including health data and specimens, from people with CF who do not take CFTR modulators. This data may be used to inform CF research, help design CF clinical trials and support the development of new treatments for people with CF who do not take CFTR modulators. Another goal of this study is to learn about research involvement for people with CF who do not take CFTR modulators, engage them in research, and give them an opportunity to learn about what is involved in participating in a CF research study. Type: Observational Start Date: Sep 2024 |
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SAfety of Regional Citrate Anticoagulation (SARCA Study)
Fresenius Medical Care North America
Acute Kidney Injury
ESRD
This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional
Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients
Requiring Continuous Renal Replacement Therapy (SARCA Study). expand
This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study). Type: Interventional Start Date: Oct 2023 |
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Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)
Mirum Pharmaceuticals, Inc.
Fragile X Syndrome
This study is a multicenter, double-blind, randomized, placebo-controlled study to assess
the safety and tolerability of 3 doses of MRM-3379 in male participants with Fragile X
Syndrome ages 16 to 45 (inclusive). In addition, a parallel cohort of participants ages
13 to <16 will receive open-label1 expand
This study is a multicenter, double-blind, randomized, placebo-controlled study to assess the safety and tolerability of 3 doses of MRM-3379 in male participants with Fragile X Syndrome ages 16 to 45 (inclusive). In addition, a parallel cohort of participants ages 13 to <16 will receive open-label MRM-3379. All participants will participate for 12 weeks of treatment. The study is also intended as a proof-of-concept investigation to evaluate whether MRM-3379 can improve FXS symptoms Type: Interventional Start Date: Nov 2025 |
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Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in1
Genmab
Endometrial Cancer
Recurrent or Progressive Endometrial Cancer
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to
treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard
medical care for the treatment of recurrent or progressive endometrial cancer (EC)
following prior therapy. There is an equal1 expand
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s). Type: Interventional Start Date: Nov 2025 |
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RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
Reunion Neuroscience Inc
Adjustment Disorder
The purpose of this study is to determine if treatment with a single dose of RE104 for
Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms
in participants with Adjustment Disorder due to cancer or other illnesses such as
Amyotrophic Lateral Sclerosis (ALS), Mult1 expand
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo. Type: Interventional Start Date: Jul 2025 |
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A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Takeda
Immune Thrombocytopenic Purpura (ITP)
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly
destroys platelets, which are cells that help stop bleeding. This leads to a low number
of platelets, making it easier to bruise or bleed. The main aim of this study is to learn
whether mezagitamab, when given j1 expand
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously [SC]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it. The participants will be treated with mezagitamab for up to 6 months. During the study, participants will visit their study clinic several times. Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study). Type: Interventional Start Date: Feb 2025 |
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RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects1
Cabaletta Bio
Systemic Lupus Erythematosus
Lupus Nephritis
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201
in Subjects With Active Systemic Lupus Erythematosus expand
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus Type: Interventional Start Date: Feb 2024 |
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ARISe at UMass Chan
University of Massachusetts, Worcester
Vaccination
Vaccination Promotion
The goal is to identify the most impactful strategies for capturing attention and
enhancing effectiveness of vaccine promotion messages. This will be done using an online
survey that employs remote eye-tracking and self report measures to evaluate response to
sample vaccine promotion social media c1 expand
The goal is to identify the most impactful strategies for capturing attention and enhancing effectiveness of vaccine promotion messages. This will be done using an online survey that employs remote eye-tracking and self report measures to evaluate response to sample vaccine promotion social media content in rural populations in New England. Participants will be randomly assigned into one of 14 conditions in a 2(source: expert vs. influencer) by 7 (themes: constructs from 7C Vaccine Framework) experiment and view sample messages and then answer questions about their attitudes and beliefs while being monitored for eye-tracking. Type: Interventional Start Date: Dec 2025 |
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A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Scler1
Novartis Pharmaceuticals
Secondary Progressive Multiple Sclerosis (SPMS)
The purpose of this study is to provide efficacy and safety data for remibrutinib in
patients with secondary progressive multiple sclerosis (SPMS) expand
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS) Type: Interventional Start Date: Nov 2025 |
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Letrozole in Uterine Leiomyosarcoma
GOG Foundation
Uterine Leiomyosarcoma
This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The
main question is will treatment with letrozole extend progression-free survival in
patients. Patients will receive 2/5 mg of letrozole daily. expand
This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The main question is will treatment with letrozole extend progression-free survival in patients. Patients will receive 2/5 mg of letrozole daily. Type: Interventional Start Date: Jul 2024 |
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A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Act1
Bristol-Myers Squibb
Colitis, Ulcerative
The purpose of this study is to evaluate the effectiveness and safety of ozanimod
(RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered
orally to pediatric participants with moderate to severe active ulcerative colitis (UC)
who have had an inadequate response to c1 expand
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. Type: Interventional Start Date: May 2022 |
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A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
Seagen, a wholly owned subsidiary of Pfizer
Urothelial Carcinoma
This study is being done to see if a drug called disitamab vedotin, alone or with
pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how
safe the drug is for participants.
Participants will have cancer that has spread in the body near where it started (locally
advan1 expand
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease. Type: Interventional Start Date: May 2022 |
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Preoperative Fasting vs. Not Fasting in Critically Ill Patients
Massachusetts General Hospital
Critical Illness
Surgical Procedure, Unspecified
Pulmonary Aspiration
Fasting
The goal of this clinical trial is to learn if fasting or not fasting before a procedure
has an effect on recovery in those who are critically ill. The main questions it aims to
answer for patients on a breathing machine who are receiving tube feeding are:
- Does the risk of lung complications1 expand
The goal of this clinical trial is to learn if fasting or not fasting before a procedure has an effect on recovery in those who are critically ill. The main questions it aims to answer for patients on a breathing machine who are receiving tube feeding are: - Does the risk of lung complications and death differ between those who are not fasting, which may have a higher chance of allowing tube feeding to enter the lungs, and fasting, which temporarily stops nutrition before a procedure? - Is there a difference in recovery times, hospital stays, infection rates, need for organ support, safety, and nutrition for those who either fast or do not fast before a procedure? - What is the relationship between nutrition and clinical outcomes? Researchers will compare not fasting and fasting to see if it has an effect on recovery. Participants will: - Be assigned by chance (like a coin toss) to one of two groups. One group (fasting group) will have their tube feeding stopped at least 8 hours before their procedure. The other group (not fasting group) will have their tube feeding stopped right before their procedure. - Be monitored via medical record for amount of protein and calories received, and any complications related to fasting/not fasting. - Data from routine electronic medical records will be reviewed to determine how participants are doing 3 months after their procedure. ' Type: Interventional Start Date: Apr 2025 |
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A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumor1
Children's Oncology Group
Stage I Mixed Cell Type Kidney Wilms Tumor
Stage II Mixed Cell Type Kidney Wilms Tumor
Stage III Mixed Cell Type Kidney Wilms Tumor
Stage IV Mixed Cell Type Kidney Wilms Tumor
This phase III trial studies using risk factors in determining treatment for children
with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common
type of kidney cancer in children, and FHWT is the most common subtype. Previous large
clinical trials have established treatme1 expand
This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT. Type: Interventional Start Date: Apr 2025 |
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Nectero EAST System Clinical Study
Nectero Medical, Inc.
Abdominal Aortic Aneurysm
The purpose of this randomized clinical trial is to treat patients with small to
mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a
locally delivered, single-dose endovascular treatment. The main question the study aims
to answer is to demonstrate efficacy of1 expand
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years. Type: Interventional Start Date: Oct 2023 |
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A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab1
National Cancer Institute (NCI)
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and
nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard
treatment alone in improving survival in patients with stage I and II classical Hodgkin
lymphoma. Brentuximab vedotin i1 expand
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). 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. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone. Type: Interventional Start Date: May 2023 |
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Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer
SWOG Cancer Research Network
Previously Treated Non-Small Cell Lung Cancer
This screening and multi-sub-study randomized phase II/III trial will establish a method
for genomic screening of similar large cancer populations followed by assigning and
accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type
of cancer trait (biomarker) will dete1 expand
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies. Type: Interventional Start Date: Feb 2019 |
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Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment1
National Cancer Institute (NCI)
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 durvalumab to the usual approach (patient observation)
after surgery for the treatment of patients with early-stage non-small cell lung cancer.
Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune
system attack the cancer, and may in1 expand
This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach. Type: Interventional Start Date: Apr 2025 |