Search Results
MT2026-02: A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis (SWOG S2213)
The purpose of this study is to compare two treatment approaches for people with amyloidosis: daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) chemotherapy followed by an autologous stem cell transplant versus Dara-VCD followed by daratumumab maintenance therapy without a stem cell transplant.
• diagnosis of systemic amyloid light chain (AL) amyloidosis
• may receive up to one cycle (or 28 days) of therapy prior to starting the study
• may be receiving chronic corticosteroids if they are being given for other disorders
• must be willing to undergo high dose chemotherapy and autologous stem cell transplantation
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding
• other uncontrolled illnesses including diabetes, hypertension, heart or lung disease
• see link to clinicaltrials.gov for complete exclusion criteria
A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (HARMONi-7)
The purpose of this research is to measure the safety and effectiveness of ivonescimab compared to pembrolizumab. Ivonescimab is an antibody designed to block proteins that help cancer cells grow and spread, and by blocking these proteins may potentially slow cancer progression. Participants will have a 50% chance of being assigned to either the ivonescimab treatment group or the pembrolizumab treatment group.
• may be restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• diagnosis of metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC)
• have not received any treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
• small cell lung cancer
• known genetic alterations that have treatment options
• have received treatment for this cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS)
This study is being conducted to compare the efficacy of subcutaneous amivantamab plus lazertinib in previously untreated EGFR mutated non-small cell lung cancer OR subcutaneous amivantamab plus chemotherapy after having received prior therapy for EGFR mutated non-small cell lung cancer.
• new diagnosis of non-small cell lung cancer (NSCLC) OR metastatic (in other areas of the body) or is too advanced for treatment that will cure the cancer
• tumor has an epidermal growth factor receptor gene (EGFR) mutation
• able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work, but can't do strenuous physical activity
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
• not have fully recovered from surgery, or has surgery planned during the time the participant is expected to be in the study
• uncontrolled tumor-related pain
A Window of Opportunity Trial of Mirdametinib plus Vorinostat for NF1 Associated, Malignant Peripheral Nerve Sheath Tumor; MPNST (Le-Na)
This is a small, Phase 0, window of opportunity study to provide human experience to support our pre-clinical data and gain preliminary information regarding the safety and tolerability of mirdametinib and vorinostat when given in combination.
• Known Neurofibromatosis type 1 (NF-1) syndrome based on current diagnostic criteria
• Diagnosis of suspected MPNST by PET or MRI imaging
• Confirmation of histone H3 lysine 27 trimethylation-negative MPSNT by immunohistochemistry
• Twelve years of age or older - Complete blood count (CBC), platelet, liver and kidney function within institutional normal limits performed within 14 days of 1st dose of study drug
• Must be able to swallow capsules
• Females of childbearing potential must use highly effective contraception (see inclusion criteria section) from the time of study enrollment through 6 months after the last dose of vorinostat and mirdametinib
• Males with partners of childbearing potential must use highly effective contraception from the time of study enrollment through 3 months after the last dose of vorinostat
• Provides voluntary written consent prior to any study related activities, with parental/guardian consent and assent for those 12 to 17 years of age at enrollment
• Pregnant or breastfeeding – females of childbearing potential must have a negative pregnancy test (serum and urine) within 7 days prior to the 1st dose of the study drugs
• Significant cardiac disease
• Ophthalmologic conditions
• Radiation therapy or chemotherapy in the past year
• Participants receiving systemic or ocular glucocorticoid therapy within 14 days prior to the first dose of study treatment
MT2015-25: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
The primary purpose of this study is to gain information, especially disease free outcomes, using the tandem approach as compared to the historical information of using a single transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery and how patients are doing at 3 months and 1 year after the treatment. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.
• less than 30 years old when diagnosis of neuroblastoma is made
• no uncontrolled infection
• recovered from acute toxicities of last cycle of induction chemotherapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients with Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) with Documented Viral Infections with Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
The purpose of this research study is to see whether an experimental drug, PUL-042 Inhalation Solution (PUL-042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with viral infections due to PIV, hMPV, or RSV. Participants will receive PUL-042 or a placebo (an inactive agent that appears identical to PUL-042) through a nebulizer. This is a machine that uses a small motor to turn liquid into a mist, like a humidifier, so you can breathe the drug into your lungs. Participants will receive the experimental drug, PUL-042, or a placebo 3 times over a 6-day period.
• nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) AND
• diagnosis of a hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipient of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder
• have undergone active chemotherapy within 6 months or are on an immunosuppressive therapy
• symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough
• must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• pulse oximetry of hemoglobin saturation less than 93% on room air
• history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure
• positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2025-50: An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients with Castration Resistant Prostate Cancer (CRPC)
The main purpose of first part of this study is to see if an experimental cell therapy called AB-3028 is a safe and effective treatment for people with metastatic castration resistant prostate cancer (mCRPC). AB-3028 is a personalized cell therapy made from your own white blood cells. The main goals of the first part are to test the safety of the treatment at different dose levels and find the recommended dose for the second part of the study.
• confirmed adenocarcinoma of the prostate
• progressive metastatic castration-resistant prostate cancer
• prior treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
• Central nervous system (CNS) metastatic disease, leptomeningeal disease, or spinal cord compression
• unwilling to participate in an extended period of monitoring for side effects
• see link to clinicaltrials.gov for complete Exclusion criteria
Identifying hearing loss through neural responses to engaging stories
This research study aims to develop a more efficient hearing test that uses brain activity measured with electroencephalographic (EEG) while listening to narrated stories to identify hearing loss at different sound frequencies.
• adults aged 18-29 years
• normal hearing
• proficient in spoken English
• neurological problems
• auditory neuropathy spectrum disorder (ANSD)
• wear a cochlear implant
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: THE RESTORATIVE303 STUDY (RESTORATiVE303)
The purpose of RESTORATiVE303 is to see if the study drug, which is called VE303, is safe and effective in preventing another episode of Clostridioides Difficile Infection (CDI). VE303 is an investigational drug that has 8 strains of live bacteria, called “commensals.” Commensals are the type of bacteria that live in harmony with the body, without harming health. These specific bacteria are often found in the intestines of normal, healthy people. They were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make one sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.
• at least 12 years old
• laboratory-confirmed Clostridium Difficile Infection (CDI) and at least one prior occurrence of CDI within the last 6 months
• OR 75 years or older with laboratory confirmed CDI
• OR CDI with additional risk factors
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
• history of chronic diarrhea unrelated to CDI
• history of celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months) of intestinal ischemia or ischemic colitis
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
This study is testing an investigational drug called XmAb541 for people with advanced solid tumors that test positive for a protein called CLDN6. XmAb541 is a type of immunotherapy designed to help the body's immune system recognize and attack cancer cells. The first part of the study will test different doses of XmAb541 to determine a safe and appropriate dose for future research. Once a recommended dose is identified, additional participants will receive that dose in the second part of the study. Researchers will evaluate the safety of XmAb541, how the body responds to the treatment, and whether it shows signs of helping to control or shrink cancer.
• ovarian, fallopian tube, peritoneal, endometrial, uterine, or another CLDN6-positive cancer that has returned, spread, or not responded to previous treatment
• able to carry out most daily activities with limited assistance
• see link to ClinicalTrials.gov for complete Inclusion Criteria
• active autoimmune disease
• significant heart, lung, or gastrointestinal disease
• active hepatitis B or hepatitis C infection
• see link to ClinicalTrials.gov for complete Exclusion Criteria
MT2023-46: A Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma
We want to find out whether lifileucel is safe and works in treating untreated, unresectable or metastatic melanoma. Lifileucel is a type of medicine, known as immunotherapy, that uses your body’s immune system to fight cancer. Lifileucel is also called “tumor infiltrating lymphocytes” (TIL) and is made up of specialized white blood cells known as lymphocytes or “T cells” obtained from a piece of your tumor. T cells are a part of your immune system that help your body fight against infections and diseases including fight cancer.
• 18 to 70 years old (in certain cases, people older than 70 may be able to enroll)
• diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma
• may not be able to do physically strenuous activity but walking and able to do light or sedentary work, e.g., light house work, office work
• participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control
• see link to clinicaltrials.gov for complete Inclusion criteria
• melanoma of uveal/ocular (eye) origin
• symptomatic untreated brain metastases
• had another cancer in the previous 3 years
• history of allogeneic cell or organ transplant
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1b Study with IMGN151 Monotherapy and Combinations in Subjects with Gynecologic Cancers
This study is being done to test whether IMGN151, given alone or in combination with approved cancer treatments, is safe, well tolerated, and effective for treating ovarian, fallopian tube, or primary peritoneal cancer. Researchers will also study how the body responds to and processes IMGN151 when given at different doses.
• diagnosis of ovarian, fallopian tube, or primary peritoneal cancer
• completed previous cancer treatment before starting the study and have recovered from treatment-related side effects
• able to carry out normal daily activities with little or no assistance
• see link to ClinicalTrials.gov for complete inclusion criteria
• prior treatment with an FRα-targeted therapy
• see link to ClinicalTrials.gov for complete exclusion criteria
An Open-Label Multiple-Dose, 52-Week Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents (ages: 12 to <18 years) with Conditions Associated with Deficiency or Absence of Endogenous Testosterone Due to Primary or Secondary Hypogonadism (Congenital or Acquired)
This is a study to see if a new drug, named XYOSTED Injection (study drug) will help in the treatment of male adolescents ages 12 to less than 18 years old who have low or no testosterone due to a medical condition called Hypogonadism. Male Hypogonadism is a condition in which the body doesn’t produce enough of the hormone called testosterone that plays a key role in masculine growth and development during puberty. Participation in the study will last 52 weeks.
• 12 to < 18 years of age
• diagnosed with a deficiency or absence of testosterone due to hypogonadism
• if receiving testosterone treatment, must be on a stable dose for at least 12 weeks before starting the study
• body mass index (BMI)-for-age greater than the 5th percentile and weigh at least 40 kg (88 pounds)
• see link to clinicaltrials.gov for complete Inclusion criteria
• suspected or known constitutional growth delay in growth and puberty (CDGP)
• possible nutritional or gastrointestinal disorder that may impact growth
• allergy to foods or products containing sesame seeds or sesame oil
• history of suicidal behavior suicide attempts
• have a history of drug or alcohol abuse
• see link to clinicaltrials.gov for complete Exclusion criteria
A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). (APPARENT)
To evaluate the efficacy and safety of iptacopan compared to placebo in patients with idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN)
• 12 to 60 years old
• diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to starting the study for adults and within 3 years for adolescents
• must have a vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• have had cell or a solid organ transplantation, including kidney transplantation
• Body mass index (BMI) >38 kg/m2
• Body weight <35 kg (77 pounds)
• additional criteria that study staff will review
MT2025-31: A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)
The purpose of this study is to test a new CAR T-cell therapy called AZD0120 in adults with multiple myeloma that has returned or has not responded to previous treatments. Researchers want to learn whether this therapy is safe, determine the best dose to use, and see how well it works against the cancer. The study will also look at how the treatment affects the immune system and participants’ quality of life.
• diagnosed with multiple myeloma
• have multiple myeloma that has come back or has not responded to treatment
• have received at least 3 prior lines of treatment, including commonly used multiple myeloma therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• had serious side effects from prior CAR T-cell or similar immune-based therapies
• have another active cancer, significant medical condition (such as heart, neurological, mental health, autoimmune, or serious infection-related conditions), or plasma cell leukemia (some exceptions may apply)
• have had a recent stroke, seizure, bleeding in the brain, dementia, or major changes in mental status
• have multiple myeloma affecting the brain or central nervous system
• see link to clinicaltrials.gov for complete exclusion criteria
Phase I Study of Peptide Alarm Therapy (PAT) Administered by Intratumoral Injection with a PD-1/PD-L1 Inhibitor in Patients with Solid Tumor Cancers Who Have Failed Two Prior Therapies
This study is testing an “investigational” drug referred to as peptide alarm therapy (PAT) that was specially made for this study. PAT is using the peptide to stimulate the immune system for people who have failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi). The goal of the 1st part of the study is to identify an acceptable, safe dose of PAT and up to 3 dose levels of PAT will be tested. If dose level 3 is reached without toxicity, it becomes the dose used for the next part of the study. In the 2nd part of the study, additional patients are treated at the PAT dose identified as safe in the 1st part to gain additional safety information and provide an initial estimate of anti-cancer effect.
• positive for Cytomegalovirus (CMV) and Epstein–Barr virus (EBV
• failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi).
• strenuous activity may be restricted; can do light work; able to walk
• people of childbearing potential or with partners of childbearing potential must be willing to abstain from heterosexual activity or use a highly effect form of contraception from the time of study enrollment until at least 4 months after the last dose study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breast feeding
• active metastases to the central nervous system
• active autoimmune disease that has required systemic treatment in the past 2 years
• history of bone marrow and/or solid organ transplant
• other active medical conditions
• see link to clinicaltrials.gov for complete Exclusion criteria
Voice Amplifier to Enhance Critical Care Coordination among Masked Providers
The proposed project seeks to improve speech intelligibility among healthcare workers who wear personal protective equipment for occupational safety while caring for patients with infectious diseases. Respiratory protective equipment such as filtering facepiece respirators, elastomeric half- and full-facepiece respirators and powered air-purifying respirators are routinely worn in the critical care unit as components of personal protective equipment for occupational safety when caring for patients with infectious diseases including COVID-19. Diminished speech intelligibility has been observed to be associated with certain types of respiratory protective equipment. Effective verbal exchanges are vital in critical care and significant reductions in speech intelligibility impact many complex tasks. The project will include two human studies testing a newly designed noninvasive speaker like device as a tool for improved communication
• age 18 or older
• normal hearing (self-reported)
• able to speak and read English
• use of a device for hearing, such as hearing aid or cochlear implant
MT2022-44 Analysis of Autoinflammation in Chronic Granulomatous Disease Patients Undergoing Hematopoietic Cell Transplantation or Gene Therapy (PIDTC 6908)
CGD disorders are a group of diseases that cause the immune system to function abnormally, leading to infections, autoimmunity and/or inflammation that can begin early in life. CGD is usually caused by changes in certain genes in DNA. Researchers are trying to learn what types of medical problems patients with CGD have and how these respond to treatment, including bone marrow transplantation and gene therapy. Researchers also want to learn which genes cause CGD and how specific gene abnormalities lead to medical problems.
• confirmed diagnosis of Chronic Granulomatous Disease (CGD)
• to be scheduled to undergo HCT or GT within one year of enrollment
• additional inclusion criteria (study staff will review)
• .presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD
• HIV infection
• past or current medical problems or findings from physical examination or laboratory testing that are not listed above which, in the opinion of the investigator, may pose additional risks from participation
MT2024-38: A Phase 1/2 Open-Label, Single-Ascending-Dose Study of EN-374, a Helper-Dependent Adenoviral-Based Gene Therapy, in Participants with X-Linked Chronic Granulomatous Disease
To evaluate the safety of the EN-374 treatment regimen (HSC mobilization, immune prophylaxis, EN-374 dose and administration, and enrichment of HSCs with O6BG/TMZ).
• at least 18 years old for initial phase of the study and then at least 3 months old for later phase
• diagnosis of X-CGD
• history of at least 1 severe infection requiring medical intervention or chronic inflammatory disorder
• does not have a suitable, available and willing human related donor
• see link to clinicaltrials.gov for complete Inclusion criteria
• active infection
• history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• had investigational gene therapy
• see link to clinicaltrials.gov for complete Exclusion criteria
Feasibility of Using a Conversational Agent for Promoting Smoking Cessation Treatment Utilization
This study is testing a new digital tool designed to help people who smoke during a quit attempt. The tool is a conversational program that uses artificial intelligence to provide personalized support and suggestions when people are facing situations where they might be more likely to smoke. The goal of the study is to see how easy the tool is to use, whether people find it helpful, and whether it may support smoking cessation.
• 21 years of age or older
• identify as Black or African American
• currently smoke cigarettes and meet minimum smoking requirements for the study
• willing to make a quit attempt within the next 30 days
• see link to ClinicalTrials.gov for complete inclusion criteria
• current use of prescription nicotine medications requiring clinical monitoring
• medical conditions or medications that may significantly interfere with smoking behavior or study participation
• pregnant or breastfeeding
• see link to ClinicalTrials.gov for complete exclusion criteria
A Phase 1, Open-label, Ascending Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Recombinant Human Heparan N-Sulfatase (rhHNS, GC1130A) Via Intracerebroventricular Access Device in Patients with Sanfilippo Syndrome Type A (MPS IIIA).
The purpose of the study is to see if GC1130A, delivered directly to the central ventricle of the brain is safe and tolerable as a means of treating the neurologic disease in MPS 3A.
• documented MPS IIIA diagnosis
• ≥ 24 months and ≤ 72 months of age
• significant non-MPS IIIA related central nervous system impairment
• previous complication from intraventricular drug administration
• contraindications for MRI scans and for neurosurgery
• received treatment with any investigational drug or a device intended as a treatment for MPS IIIA within 30 days
• received a hematopoietic stem cell or bone marrow transplant or received gene therapy
A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients with Metastatic Castration-Resistant Prostate Cancer (CRPC)
The purpose of this research is to collect information about the safety and tolerability of the study drug ACE-232, along with how well it works to control metastatic castration-resistant prostate cancer (mCRPC).
• diagnosis of Metastatic Castration-resistant Prostate Cancer (MCRPC) with - ongoing androgen deprivation therapy (ADT) or had bilateral orchiectomy
• difficult to treat or intolerant to standard treatment
• may be restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
• spinal cord compression or known brain metastases
• severe cardiovascular disorders
• known gastrointestinal (GI) disorder or GI procedure
• poorly controlled diabetes
• active or uncontrolled autoimmune disease
• see link to clinicaltrials.gov for complete exclusion criteria
COG AALL1821 - A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 147294) in Combination with Nivolumab (NSC # 748726, IND# 147294), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to < 31 Years Old with First Relapse
The overall goal of this study is to determine if treating first relapse B-cell acute lymphoblastic leukemia (B-ALL) with a combination of blinatumomab and nivolumab is more effective than blinatumomab alone.
• 1 to 30 years old
• must have first relapse of CD19+ B-ALL (relapse blasts must express CD19)
• must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• see link to clinicaltrials.gov for completed Inclusion criteria
• other types of blood disorders including: B-lymphoblastic lymphoma (B-LLy), Burkitt leukemia/lymphoma or mature B-cell leukemia, Philadelphia chromosome positive (Ph+) B-ALL, mixed phenotype acute leukemia (MPAL), known Charcot-Marie-Tooth disease, MYC translocation associated with mature (Burkitt) B-cell ALL
• active, uncontrolled infection
• significant central nervous system pathology including history of severe neurologic disorder or autoimmune disease with CNS involvement
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, STUDY EVALUATING THE EFFICACY AND SAFETY OF NANVURANLAT IN PATIENTS WITH PREVIOUSLY TREATED ADVANCED BILIARY TRACT CANCER (Beacon-BTC)
This study is for people with advanced biliary tract cancer (cancer of the bile ducts or gallbladder) that cannot be removed with surgery or has spread to other parts of the body. Participants must have previously received one standard chemotherapy treatment for advanced disease. Researchers are studying an investigational medication called nanvuranlat to see if it is safe and effective for treating advanced biliary tract cancer. The study will compare nanvuranlat with standard treatment to learn how well it works, monitor its safety, and better understand how it affects the body and the cancer.
• diagnosed with advanced or metastatic biliary tract cancer (including intrahepatic, extrahepatic, or gallbladder cancer) that cannot be removed with surgery
• previously received one platinum-based chemotherapy treatment for advanced disease
• able to carry out light daily activities
• see link to clinicaltrials.gov for complete Inclusion criteria
• received certain cancer treatments, radiation therapy, or major surgery too recently before starting the study
• active or untreated brain metastases or uncontrolled serious medical conditions
• pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors with Azirkitug as a Single Agent and in Combination(s) with Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan
This trial will evaluate whether azirkitug (ABBV-514) as monotherapy and in combination with budigalimab (ABBV-181) or bevacizumab is safe and tolerable for people with locally advanced or metastatic solid tumors.
• may not be able to do strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• advanced or metastatic cancer who have previously been treated
• see link to clinicaltrials.gov for complete Inclusion Criteria
• active autoimmune or immunodeficiency disease
• women who are pregnant
• significant heart disease
• see link to clinicaltrials.gov for complete Exclusion criteria
A Parallel-Arm, Phase 3, Open-Label, Active-controlled, Multicenter (Global), Randomized Clinical Trial to Investigate the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Participants with Growth Failure or Short Stature due to Growth Hormone Sufficient Causes- Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature
This study is evaluating two growth hormone treatments in children with short stature due to Turner syndrome, SHOX deficiency, being born small for gestational age without catch-up growth, or idiopathic short stature. Researchers want to compare how well the two treatments support growth, monitor their safety, and better understand how they affect the body. Participation in the study will last approximately 52 weeks.
• 2 to 18 years of age
• diagnosed with Turner syndrome, SHOX deficiency, born small for gestational age without catch-up growth, or idiopathic short stature
• have not previously received growth hormone or growth hormone-promoting therapy
• see link to ClinicalTrials.gov for complete inclusion criteria
• receiving medications or have a medical condition that may affect growth
• uncontrolled diabetes, thyroid disease, or other significant medical conditions
• pregnant or breastfeeding
• see link to ClinicalTrials.gov for complete exclusion criteria
A PHASE 2 STUDY OF ALISERTIB IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH HR+, HER2-NEGATIVE RECURRENT OR METASTATIC BREAST CANCER (ALISCA-Breast1)
The purpose of this study is to see if the study drug, called alisertib, in combination with an ‘endocrine therapy’ such as anastrozole, letrozole, exemestane, tamoxifen or fulvestrant can help people with HR+, HER2-negative recurrent or metastatic breast cancer. The study will also look at how well people tolerate treatment with alisertib in combination with one of the endocrine therapies that are commonly used in clinical practice.
• diagnosis of adenocarcinoma of the breast that has reoccurred of spread to other areas of the body (metastatic)
• treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete inclusion criteria
• treatment with chemotherapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete exclusion criteria
Minnesota KPMP CKD and Resilient Diabetes Recruiting Site (KPMP)
The Kidney Precision Medicine Project (KPMP) is a research study. Our goal is learn more about kidney injury and kidney disease. By studying your kidneys, we may learn more about why chronic kidney disease happens and how to treat it more effectively or even how to prevent it. Or participants have had diabetes for many years and have not clinical signs of chronic kidney disease. By studying your kidneys, we may learn more about the factors that help protect you from kidney disease. KPMP will last for at least 10 years.
• at least 18 years old
• diagnosis acute or chronic kidney (renal) disease with diabetes mellitus (type 1 or 2) OR associated with hypertension
• persistent kidney damage based on specific lab values at least 3 months apart (study staff will review)
• Body Mass Index (BMI) greater than 40 kg/m2
• any allergic reaction to iodinated contrast
• receiving chemotherapy or radiation to treat cancer
• transplant recipient (includes solid transplant and bone marrow)
• unwilling to receive blood transfusion (if needed)
• women who are pregnant
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
The purpose of this study is to assess whether JNJ-87189401 given in combination with pasritamig (JNJ-78278343) to men with metastatic castration-resistant prostate cancer (also known as mCRPC) can cause side effects, and to find doses for the two drugs when given in combination. Side effects are unexpected or unwanted reactions from receiving the study drugs. Additionally, the study will look at how long JNJ-87189401 and pasritamig stay in the body, how they act on the body, and how the body responds to them.
• confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted
• Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist)
• fully active, able to carry on all pre-disease performance without restriction or unable to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinical trials.gov for complete Inclusion criteria
• active autoimmune disease in the 12 months that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
• any of the following within past 6 months: myocardial infarction, severe or unstable angina, significant ventricular arrhythmias, congestive heart failure, transient ischemic attack (TIA), or Cerebrovascular accident (CVA, stroke)
• see link to clinicaltrials.gov for complete Exclusion criteria
An Observational Study of VYKATTMXR (Diazoxide Choline Extended-Release Tablets) in Patients with Prader-Willi Syndrome (PWS)
This study is collecting information from people with Prader-Willi syndrome (PWS) who are taking VYKAT XR (diazoxide choline extended-release tablets). Researchers will use information from routine medical care to learn more about the long-term safety, treatment experiences, and health outcomes of people treated with VYKAT XR.
• diagnosed with Prader-Willi syndrome (PWS)
• currently taking or planning to start VYKAT XR (diazoxide choline extended-release tablets)
• see link to ClinicalTrials.gov for complete inclusion criteria